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Ibuprofen
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 202413-001 | IBUPROFEN | TABLET | IBUPROFEN | Prescription | AB | ||
| 202413-002 | IBUPROFEN | TABLET | IBUPROFEN | Prescription | AB | ||
| 202413-003 | IBUPROFEN | TABLET | IBUPROFEN | Prescription | AB | ||
| 202413-004 | IBUPROFEN | TABLET | IBUPROFEN | Prescription | — |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 21 | Labeling | Approved | November 21, 2024 | Standard |
| Supplement | 20 | Labeling | Approved | November 15, 2024 | Standard |
| Supplement | 17 | Labeling | Approved | June 25, 2021 | Standard |
| Supplement | 16 | Labeling | Approved | June 25, 2021 | Standard |
| Supplement | 9 | Labeling | Approved | July 22, 2019 | Standard |
| Supplement | 5 | Manufacturing (CMC) | Approved | July 23, 2018 | Unknown |
| Original application | 1 | Approved | November 23, 2016 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260826). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingCardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. [See Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ]. • Ibuprofen tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ]. Gastrointestinal Risk • NSAIDS cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. [See Error! Hyperlink reference not valid. ].
Indications and Usage
openFDA Drug LabelingIndications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Ibuprofen tablets are indicated for relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis. Ibuprofen tablets are indicated for relief of mild to moderate pain. Ibuprofen tablets are also indicated for the treatment of primary dysmenorrhea. Controlled clinical trials to establish the safety and effectiveness of ibuprofen tablets in children have not been conducted.
Purpose
openFDA Drug LabelingPurpose Pain reliever/fever reducer **non steroidal anto-inflammatory drug
Dosage and Administration
openFDA Drug LabelingDosage and Administration Section DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ibuprofen tablets and other treatment options before deciding to use ibuprofen tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). After observing the response to initial therapy with ibuprofen tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Do not exceed 3200 mg total daily dose. If gastrointestinal complaints occur, administer ibuprofen tablets with meals or milk. Rheumatoid arthritis and osteoarthritis, including flare-ups of chronic disease: Suggested Dosage: 1200 mg to 3200 mg daily (300 mg four times a day, 400 mg, 600 mg or 800 mg three times a day or four times a day). Individual patients may show a better response to 3200 mg daily, as compared with 2400 mg, although in well-controlled clinical trials patients on 3200 mg did not show a better mean response in terms of efficacy. Therefore, when treating patients with 3200 mg/day, the physician should observe sufficient increased clinical benefits to offset potential increased risk. The dose should be tailored to each patient and may be lowered or raised depending on the severity of symptoms either at time of initiating drug therapy or as the patient responds or fails to respond. In general, patients with rheumatoid arthritis seem to require higher doses of ibuprofen tablets than do patients with osteoarthritis. The smallest dose of ibuprofen tablets that yields acceptable control should be employed. A linear blood level dose-response relationship exists with single doses up to 800 mg (see CLINICAL PHARMACOLOGY for effects of food on rate of absorption). The availability of three tablet strengths facilitates dosage adjustment. In chronic conditions, a therapeutic response to therapy with ibuprofen tablets is some times seen in a few days to a week but most often is observed by two weeks. After a satisfactory response has been achieved, the patient's dose should be reviewed and adjusted as required. Mild to moderate pain: 400 mg every 4 to 6 hours as necessary for relief of pain. In controlled analgesic clinical trials, doses of ibuprofen tablets greater than 400 mg were no more effective than the 400 mg dose. Dysmenorrhea: For the treatment of dysmenorrhea, beginning with the earliest onset of such pain, ibuprofen tablets should be given in a dose of 400 mg every 4 hours as necessary for the relief of pain.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Ibuprofen tablets are contraindicated in patients with known hypersensitivity to ibuprofen. Ibuprofen tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients [see WARNINGS , Anaphylactoid Reactions, and PRECAUTIONS , Preexisting Asthma ]. Ibuprofen tablets are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS ].
Warnings and Cautions
openFDA Drug LabelingWarnings and Precautions CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as ibuprofen, increases the risk of serious gastrointestinal (GI) events [see WARNINGS]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG [see CONTRAINDICATIONS]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ibuprofen tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs including ibuprofen tablets can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen tablets should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additional …
Warnings
openFDA Drug LabelingWARNINGS CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as ibuprofen, increases the risk of serious gastrointestinal (GI) events (see WARNINGS). Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG (see CONTRAINDICATIONS). Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up. Avoid the use of ibuprofen tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If ibuprofen tablets is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs including ibuprofen tablets, can lead to onset of new hypertension or worsening of pre-existing hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including ibuprofen tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid rete …
Do Not Use
openFDA Drug LabelingDo not use • if you have ever had an allergic reaction to ibuprofen or any other pain reliever/fever reducer • right before or after heart surgery
Ask a Doctor
openFDA Drug LabelingAsk a doctor before use if Ask a doctor before use if the stomach bleeding warning applies to you you have problems or serious side effects from taking pain relievers or fever reducers you have a history of stomach problems, such as heartburn you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma or had a stroke you are taking a diuretic
Stop Use
openFDA Drug LabelingStop use and ask a doctor if • you experience any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that does not get better • you have symptoms of heart problems or stroke: • chest pain • trouble breathing • weakness in one part or side of the body • slurred speech • leg swelling • pain gets worse or lasts more than 10 days • fever gets worse or lasts more than 3 days • redness or swelling is present in the painful area • any new symptoms appear
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The most frequent type of adverse reaction occurring with Ibuprofen tablets is gastrointestinal. In controlled clinical trials the percentage of patients reporting one or more gastrointestinal complaints ranged from 4% to 16%. In controlled studies when Ibuprofen tablets were compared to aspirin and indomethacin in equally effective doses, the overall incidence of gastrointestinal complaints was about half that seen in either the aspirin- or indomethacin-treated patients. Adverse reactions observed during controlled clinical trials at an incidence greater than 1% are listed in the table. Those reactions listed in Column one encompass observations in approximately 3,000 patients. More than 500 of these patients were treated for periods of at least 54 weeks. Still other reactions occurring less frequently than 1 in 100 were reported in controlled clinical trials and from marketing experience. These reactions have been divided into two categories: Column two of the table lists reactions with therapy with Ibuprofen tablets where the probability of a causal relationship exists: for the reactions in Column three, a causal relationship with Ibuprofen tablets has not been established. Reported side effects were higher at doses of 3200 mg/day than at doses of 2400 mg or less per day in clinical trials of patients with rheumatoid arthritis. The increases in incidence were slight and still within the ranges reported in the table. Incidence Greater than 1% (but less than 3%) Probable Causal Relationship* Precise Incidence Unknown (but less than 1%) Probable Causal Relationship** Precise Incidence Unknown (but less than 1%) Causal Relationship Unknown** GASTROINTESTINAL Nausea*, epigastric pain*, heartburn*, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or Pain, fullness of GI tract (bloating or flatulence) Gastric or duodenal ulcer with bleeding and / or perforation, gastrointestinal hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver function tests; pancreatitis CENTRAL NERVOUS SYSTEM Dizziness*, headache, nervousness Depression, insomnia, confusion, emotional liability, somnolence, aseptic meningitis with fever and coma (see PRECAUTIONS ) Paresthesias, hallucinations, dream abnormalities, pseudotumor cerebri DERMATOLOGIC Rash*, (including maculopapular type), pruritus Vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-Johnson syndrome, alopecia Toxic epidermal necrolysis, photoallergic skin reactions SPECIAL SENSES Tinnitus Hearing loss, amblyopia (blurred and/or diminished vision, scotomata and/or changes in color vision) (see PRECAUTIONS ) Conjunctivitis, diplopia, optic neuritis, cataracts HEMATOLOGIC Neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia (sometimes Coombs positive), thrombocytopenia with or without purpura, eosinophilia, decreases in hemoglobin and hematocrit (see PRECAUTIONS ) Bleeding episodes (e.g., epistaxis,menorrhagia) METABOLIC/ ENDOCRINE Decreased appetite Gynecomastia, hypoglycemic reaction, acidosis CARDIOVASCULAR Edema, fluid retention (generally responds promptly to drug discontinuation) (see PRECAUTIONS ) Congestive heart failure in patients with marginal cardiac function, elevated blood pressure, palpitations Arrhythmias (sinus tachycardia, sinus bradycardia) ALLERGIC Syndrome of abdominal pain, fever, chills, nausea and vomiting; anaphylaxis; bronchospasm (see CONTRAINDICATIONS ) Serum sickness, lupus erythematosus syndrome. Henoch Schonlein vasculitis, angioedema RENAL Acute renal failure (see PRECAUTIONS ), decreased creatinine clearance, poliuria, azotemia, cystitis, Hematuria Renal papillary necrosis MISCELLANEOUS Dry eyes and mouth, gingival ulcer, rhinitis * Reactions occurring in 3% to 9% of patients treated with ibuprofen tablets. (Those reactions occurring in less than 3% of the patients are unmarked.) ** Reactions are classified under "Probable Causal Relationship (PCR)" if there has be …
Drug Interactions
openFDA Drug LabelingDRUG INTERACTION ACE-inhibitors Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors. Aspirin Pharmacodynamic studies have demonstrated interference with the antiplatelet activity of aspirin when ibuprofen 400 mg, given three times daily, is administered with enteric coated low-dose aspirin. The interaction exists even following a once-daily regimen of ibuprofen 400 mg, particularly when ibuprofen is dosed prior to aspirin. The interaction is alleviated if immediate-release low-dose aspirin is dosed at least 2 hours prior to a once daily regimen of ibuprofen; however, this finding cannot be extended to enteric-coated low-dose aspirin [see Clinical Pharmacology /Pharmacodynamics]. Because there may be an increased risk of cardiovascular events due to the interference of ibuprofen with the antiplatelet effect of aspirin, for patients taking low-dose aspirin for cardio protection who require analgesics, consider use of an NSAID that does not interfere with the antiplatelet effect of aspirin, or non-NSAID analgesics, where appropriate. When ibuprofen tablets are administered with aspirin, its protein binding is reduced, although the clearance of free ibuprofen tablets is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential for increased adverse effects. Diuretics Clinical studies, as well as postmarketing observations, have shown that ibuprofen tablets can reduce the natriuretic effect-of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS , Renal Effects ), as well as to assure diuretic efficacy. Lithium Ibuprofen produced an elevation of plasma lithium levels and a reduction in renal lithium clearance in a study of eleven normal volunteers. The mean minimum lithium concentration increased 15% and the renal clearance of lithium was decreased by 19% during this period of concomitant drug administration. This effect has been attributed to inhibition of renal prostaglandin synthesis by ibuprofen. Thus, when ibuprofen and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. (Read circulars for lithium preparation before use of such concurrent therapy.) Methotrexate NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin-type anticoagulants Several short-term controlled studies failed to show that ibuprofen tablets significantly affected prothrombin times or a variety of other clotting factors when administered to individuals on coumarin-type anticoagulants. However, because bleeding has been reported when ibuprofen tablets and other NSAIDs have been administered to patients on coumarin-type anticoagulants, the physician should be cautious when administering ibuprofen tablets to patients on anticoagulants. The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone. H-2 Antagonists In studies with human volunteers, co-administration of cimetidine or ranitidine with ibuprofen had no substantive effect on ibuprofen serum concentrations. Pregnancy Risk Summary Use of NSAIDs, including ibuprofen tablets, can cause premature closure of the fetal ductus arteriosus and fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. Because of …
Description
openFDA Drug LabelingDESCRIPTION Ibuprofen tablets, USP contain the active ingredient ibuprofen, which is (±) - 2 - (p - isobutylphenyl) propionic acid. Ibuprofen is a white powder with a melting point of 74-77°C and is very slightly soluble in water (<1 mg/mL) and readily soluble in organic solvents such as ethanol and acetone. The structural formula is represented below: Ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), is available in 300 mg, 400 mg, 600 mg, and 800 mg tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, lecithin (soy), magnesium stearate, microcrystalline cellulose, pregelatinized starch, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, stearic acid, talc, titanium dioxide. chemical-structure.jpg
Active Ingredient
openFDA Drug LabelingActive ingredient Active ingredient (in each tablet) Ibuprofen Tablets USP, 200 mg (NSAID*). *nonsteroidal anti-inflammatory drug Purpose Purpose Pain reliever/Fever reducer
Overdosage
openFDA Drug LabelingOVERDOSAGE Approximately 1Â1⁄2 hours after the reported ingestion of from 7 to 10 ibuprofen tablets (400 mg), a 19-month old child weighing 12 kg was seen in the hospital emergency room, apneic and cyanotic, responding only to painful stimuli. This type of stimulus, however, was sufficient to induce respiration. Oxygen and parenteral fluids were given; a greenish-yellow fluid was aspirated from the stomach with no evidence to indicate the presence of ibuprofen. Two hours after ingestion the child's condition seemed stable; she still responded only to painful stimuli and continued to have periods of apnea lasting from 5 to 10 seconds. She was admitted to intensive care and sodium bicarbonate was administered as well as infusions of dextrose and normal saline. By four hours post-ingestion she could be aroused easily, sit by herself and respond to spoken commands. Blood level of ibuprofen was 102.9 Âμg/mL approximately 8Â1⁄2 hours after accidental ingestion. At 12 hours she appeared to be completely recovered. In two other reported cases where children (each weighing approximately 10 kg) accidentally, acutely ingested approximately 120 mg/kg, there were no signs of acute intoxication or late sequelae. Blood level in one child 90 minutes after ingestion was 700 Âμg/mL — about 10 times the peak levels seen in absorption-excretion studies. A 19-year old male who had taken 8,000 mg of ibuprofen over a period of a few hours complained of dizziness, and nystagmus was noted. After hospitalization, parenteral hydration and three days bed rest, he recovered with no reported sequelae. In cases of acute overdosage, the stomach should be emptied by vomiting or lavage, though little drug will likely be recovered if more than an hour has elapsed since ingestion. Because the drug is acidic and is excreted in the urine, it is theoretically beneficial to administer alkali and induce diuresis. In addition to supportive measures, the use of oral activated charcoal may help to reduce the absorption and reabsorption of ibuprofen tablets.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Ibuprofen Tablets, USP are available in the following strengths: The 400 mg tablets are film-coated clear, round shaped, white tablets, debossed “C5” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets – NDC 71921-180-01 Bottles of 500 tablets – NDC 71921-180-50 (PACKAGE NOT CHILD-RESISTANT) The 600 mg tablets are film -coated clear, oval-shaped, white tablets, debossed “C7” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets – NDC 71921-181-01 Bottles of 500 tablets – NDC 71921-181-50 (PACKAGE NOT CHILD-RESISTANT) The 800 mg tablets are film -coated clear, oval-shaped, white tablets, debossed “C11” on one side and plain on the other side. They are available as follows: Bottles of 100 tablets – NDC 71921-182-01 Bottles of 500 tablets – NDC 71921-182-50 (PACKAGE NOT CHILD-RESISTANT) Store at 20o to 25oC (68o to 77oF); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat 40°C (104°F). Manufactured by: Contract Pharmacal Corp. 165 Oser Avenue Hauppauge, NY 11788 USA Distributed by: Florida Pharmaceutical Products, LLC 6111 Broken Sound Pkwy NW Suite 160 Boca Raton, FL 33487 Toll Free Number: 1-800-315-0985 14464-04-21 MEDICATION GUIDE Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) What it the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" increasing use of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used : exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take a NSAIDs? Do not take NSAIDs: if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs right before or after heart bypass surgery Before taking NSAIDs, tell your healthcare provider about all your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Taking NSAIDs at about 20 weeks of pregnancy or later may harm your unborn baby. If you need to take NSAIDs for more than 2 days when you are between 20 and 30 weeks of pregnancy, your healthcare provider may need to monitor the amount of fluid in your womb around your baby. You should not take NSAIDs after about 30 weeks of pregnancy. are breastfeeding or plan to breast feed Tell your healthcare provider about all of the medicines you take, including prescription or over the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medic …
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: IBUPROFEN. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | May 2, 2018 | Time-Cap Laboratories, Inc. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Terminated |
| Class II | August 9, 2017 | Time-Cap Laboratories, Inc. | Presence of foreign tablets/capsules: Ibuprofen Tablets USP, 600 mg bottles were found to contain some Ibuprofen Tablets USP 800 mg. | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2549-0 | 50090-2549 | A-S Medication Solutions | 4 TABLET, FILM COATED in 1 BOTTLE (50090-2549-0) | October 19, 2018 |
| 50090-2549-4 | 50090-2549 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-2549-4) | November 7, 2016 |
| 50090-2549-5 | 50090-2549 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2549-5) | October 20, 2016 |
| 50090-2549-7 | 50090-2549 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-2549-7) | October 20, 2016 |
| 50090-2597-0 | 50090-2597 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2597-0) | November 4, 2016 |
| 50090-2625-0 | 50090-2625 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-2625-0) | August 9, 2018 |
| 50090-2625-2 | 50090-2625 | A-S Medication Solutions | 16 TABLET, FILM COATED in 1 BOTTLE (50090-2625-2) | January 26, 2017 |
| 50090-2625-3 | 50090-2625 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2625-3) | November 21, 2016 |
| 50090-2625-4 | 50090-2625 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-2625-4) | November 18, 2016 |
| 50090-2625-5 | 50090-2625 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-2625-5) | November 17, 2016 |
| 50090-2625-7 | 50090-2625 | A-S Medication Solutions | 40 TABLET, FILM COATED in 1 BOTTLE (50090-2625-7) | November 17, 2016 |
| 50090-2625-8 | 50090-2625 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-2625-8) | November 29, 2016 |
| 50090-2625-9 | 50090-2625 | A-S Medication Solutions | 24 TABLET, FILM COATED in 1 BOTTLE (50090-2625-9) | December 8, 2016 |
| 50090-2626-0 | 50090-2626 | A-S Medication Solutions | 15 TABLET, FILM COATED in 1 BOTTLE (50090-2626-0) | June 12, 2017 |
| 50090-2626-1 | 50090-2626 | A-S Medication Solutions | 21 TABLET, FILM COATED in 1 BOTTLE (50090-2626-1) | December 14, 2016 |
| 50090-2626-4 | 50090-2626 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-2626-4) | January 20, 2017 |
| 50090-2626-5 | 50090-2626 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-2626-5) | November 17, 2016 |
| 50090-2629-0 | 50090-2629 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-2629-0) | November 17, 2016 |
| 50090-3007-0 | 50090-3007 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-3007-0) | May 15, 2017 |
| 50090-3007-2 | 50090-3007 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-3007-2) | May 8, 2017 |
| 50090-5223-0 | 50090-5223 | A-S Medication Solutions | 50 TABLET, FILM COATED in 1 BOTTLE (50090-5223-0) | October 7, 2020 |
| 50090-5223-3 | 50090-5223 | A-S Medication Solutions | 24 TABLET, FILM COATED in 1 BOTTLE (50090-5223-3) | October 7, 2020 |
| 50090-5223-8 | 50090-5223 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5223-8) | October 7, 2020 |
| 50090-5818-0 | 50090-5818 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-5818-0) | October 19, 2021 |
| 50090-5818-2 | 50090-5818 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-5818-2) | October 19, 2021 |
| 50090-5819-0 | 50090-5819 | A-S Medication Solutions | 16 TABLET, FILM COATED in 1 BOTTLE (50090-5819-0) | October 19, 2021 |
| 50090-5819-1 | 50090-5819 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-5819-1) | October 19, 2021 |
| 50090-5819-3 | 50090-5819 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-5819-3) | October 19, 2021 |
| 50090-5819-4 | 50090-5819 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-5819-4) | October 19, 2021 |
| 50090-5819-8 | 50090-5819 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-5819-8) | October 19, 2021 |
| 50090-6645-0 | 50090-6645 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6645-0) | August 29, 2023 |
| 50090-7281-5 | 50090-7281 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7281-5) | October 8, 2024 |
| 50090-7281-7 | 50090-7281 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7281-7) | October 8, 2024 |
| 50090-7282-0 | 50090-7282 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7282-0) | October 8, 2024 |
| 50090-7283-0 | 50090-7283 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7283-0) | October 8, 2024 |
| 50090-7283-1 | 50090-7283 | A-S Medication Solutions | 15 TABLET, FILM COATED in 1 BOTTLE (50090-7283-1) | October 8, 2024 |
| 50090-7283-2 | 50090-7283 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7283-2) | October 8, 2024 |
| 50090-7283-3 | 50090-7283 | A-S Medication Solutions | 45 TABLET, FILM COATED in 1 BOTTLE (50090-7283-3) | October 8, 2024 |
| 50090-7283-4 | 50090-7283 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7283-4) | October 8, 2024 |
| 50090-7283-5 | 50090-7283 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7283-5) | October 8, 2024 |
| 50090-7283-7 | 50090-7283 | A-S Medication Solutions | 21 TABLET, FILM COATED in 1 BOTTLE (50090-7283-7) | October 8, 2024 |
| 50090-7283-8 | 50090-7283 | A-S Medication Solutions | 12 TABLET, FILM COATED in 1 BOTTLE (50090-7283-8) | October 8, 2024 |
| 50090-7283-9 | 50090-7283 | A-S Medication Solutions | 40 TABLET, FILM COATED in 1 BOTTLE (50090-7283-9) | October 8, 2024 |
| 50090-7286-0 | 50090-7286 | A-S Medication Solutions | 15 TABLET, FILM COATED in 1 BOTTLE (50090-7286-0) | October 10, 2024 |
| 50090-7286-1 | 50090-7286 | A-S Medication Solutions | 21 TABLET, FILM COATED in 1 BOTTLE (50090-7286-1) | October 8, 2024 |
| 50090-7286-4 | 50090-7286 | A-S Medication Solutions | 28 TABLET, FILM COATED in 1 BOTTLE (50090-7286-4) | October 8, 2024 |
| 50090-7286-5 | 50090-7286 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7286-5) | October 8, 2024 |
| 50090-7288-0 | 50090-7288 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7288-0) | October 8, 2024 |
| 50090-7288-2 | 50090-7288 | A-S Medication Solutions | 16 TABLET, FILM COATED in 1 BOTTLE (50090-7288-2) | October 8, 2024 |
| 50090-7288-3 | 50090-7288 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7288-3) | October 8, 2024 |
| 50090-7288-4 | 50090-7288 | A-S Medication Solutions | 60 TABLET, FILM COATED in 1 BOTTLE (50090-7288-4) | October 8, 2024 |
| 50090-7288-5 | 50090-7288 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7288-5) | October 8, 2024 |
| 50090-7288-7 | 50090-7288 | A-S Medication Solutions | 40 TABLET, FILM COATED in 1 BOTTLE (50090-7288-7) | October 8, 2024 |
| 50090-7288-8 | 50090-7288 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7288-8) | October 8, 2024 |
| 50090-7288-9 | 50090-7288 | A-S Medication Solutions | 24 TABLET, FILM COATED in 1 BOTTLE (50090-7288-9) | October 8, 2024 |
| 50090-7320-0 | 50090-7320 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7320-0) | October 14, 2024 |
| 50090-7321-0 | 50090-7321 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7321-0) | October 15, 2024 |
| 50090-7788-0 | 50090-7788 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-7788-0) | November 24, 2025 |
| 50090-7789-0 | 50090-7789 | A-S Medication Solutions | 16 TABLET, FILM COATED in 1 BOTTLE (50090-7789-0) | November 24, 2025 |
| 50090-7789-1 | 50090-7789 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-7789-1) | November 24, 2025 |
| 50090-7789-3 | 50090-7789 | A-S Medication Solutions | 100 TABLET, FILM COATED in 1 BOTTLE (50090-7789-3) | November 24, 2025 |
| 50090-7789-4 | 50090-7789 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7789-4) | November 24, 2025 |
| 50090-7905-0 | 50090-7905 | A-S Medication Solutions | 500 TABLET, FILM COATED in 1 BOTTLE (50090-7905-0) | February 16, 2026 |
| 67060-001-67 | 67060-001 | ADVANCED FIRST AID, INC. | 250 PACKET in 1 CARTON (67060-001-67) / 2 TABLET, FILM COATED in 1 PACKET | April 9, 2015 |
| 67060-001-68 | 67060-001 | ADVANCED FIRST AID, INC. | 100 PACKET in 1 CARTON (67060-001-68) / 2 TABLET, FILM COATED in 1 PACKET | April 9, 2015 |
| 55301-291-03 | 55301-291 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE, PLASTIC in 1 PACKAGE (55301-291-03) / 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 55301-291-06 | 55301-291 | ARMY AND AIR FORCE EXCHANGE SERVICE | 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-291-06) | May 24, 1988 |
| 55301-291-12 | 55301-291 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE, PLASTIC in 1 CARTON (55301-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 55301-291-14 | 55301-291 | ARMY AND AIR FORCE EXCHANGE SERVICE | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-291-14) | May 24, 1988 |
| 55301-292-12 | 55301-292 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE in 1 CARTON (55301-292-12) / 100 TABLET, FILM COATED in 1 BOTTLE | May 24, 1988 |
| 55301-292-15 | 55301-292 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE in 1 CARTON (55301-292-15) / 50 TABLET, FILM COATED in 1 BOTTLE | May 24, 1988 |
| 55301-392-15 | 55301-392 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE, PLASTIC in 1 CARTON (55301-392-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | March 1, 1999 |
| 55301-393-06 | 55301-393 | ARMY AND AIR FORCE EXCHANGE SERVICE | 200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55301-393-06) | March 1, 1999 |
| 55301-393-15 | 55301-393 | ARMY AND AIR FORCE EXCHANGE SERVICE | 1 BOTTLE, PLASTIC in 1 CARTON (55301-393-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | March 1, 1999 |
| 80425-0132-1 | 80425-0132 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0132-1) | December 30, 2015 |
| 80425-0132-2 | 80425-0132 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0132-2) | December 30, 2015 |
| 80425-0132-3 | 80425-0132 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0132-3) | December 30, 2015 |
| 80425-0154-1 | 80425-0154 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0154-1) | December 21, 2015 |
| 80425-0154-2 | 80425-0154 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0154-2) | December 21, 2015 |
| 80425-0154-3 | 80425-0154 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0154-3) | December 21, 2015 |
| 80425-0154-4 | 80425-0154 | Advanced Rx Pharmacy of Tennessee, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (80425-0154-4) | May 16, 2023 |
| 80425-0243-4 | 80425-0243 | Advanced Rx Pharmacy of Tennessee, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (80425-0243-4) | January 10, 2023 |
| 80425-0046-1 | 80425-0046 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0046-1) | December 21, 2015 |
| 80425-0046-2 | 80425-0046 | Advanced Rx of Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (80425-0046-2) | December 21, 2015 |
| 80425-0046-3 | 80425-0046 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0046-3) | December 21, 2015 |
| 80425-0046-4 | 80425-0046 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0046-4) | December 21, 2015 |
| 80425-0046-5 | 80425-0046 | Advanced Rx of Tennessee, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (80425-0046-5) | December 21, 2015 |
| 80425-0089-1 | 80425-0089 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0089-1) | December 30, 2015 |
| 80425-0089-2 | 80425-0089 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0089-2) | December 30, 2015 |
| 80425-0089-3 | 80425-0089 | Advanced Rx of Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (80425-0089-3) | December 30, 2015 |
| 80425-0089-4 | 80425-0089 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0089-4) | December 30, 2015 |
| 80425-0553-1 | 80425-0553 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0553-1) | October 15, 2025 |
| 80425-0553-2 | 80425-0553 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0553-2) | October 15, 2025 |
| 80425-0553-3 | 80425-0553 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (80425-0553-3) | October 15, 2025 |
| 80425-0553-4 | 80425-0553 | Advanced Rx of Tennessee, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (80425-0553-4) | October 15, 2025 |
| 11788-008-01 | 11788-008 | AiPing Pharmaceutical, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (11788-008-01) | December 15, 2025 |
| 11788-008-05 | 11788-008 | AiPing Pharmaceutical, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (11788-008-05) | December 15, 2025 |
| 11788-008-20 | 11788-008 | AiPing Pharmaceutical, Inc. | 1250 TABLET, FILM COATED in 1 BOTTLE (11788-008-20) | September 1, 2026 |
| 11788-009-01 | 11788-009 | AiPing Pharmaceutical, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (11788-009-01) | December 15, 2025 |
| 11788-009-05 | 11788-009 | AiPing Pharmaceutical, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (11788-009-05) | December 15, 2025 |
| 11788-009-20 | 11788-009 | AiPing Pharmaceutical, Inc. | 1250 TABLET, FILM COATED in 1 BOTTLE (11788-009-20) | September 1, 2026 |
| 11788-010-01 | 11788-010 | AiPing Pharmaceutical, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (11788-010-01) | December 15, 2025 |
| 11788-010-05 | 11788-010 | AiPing Pharmaceutical, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (11788-010-05) | December 15, 2025 |
| 11788-010-20 | 11788-010 | AiPing Pharmaceutical, Inc. | 1250 TABLET, FILM COATED in 1 BOTTLE (11788-010-20) | September 1, 2026 |
| 69168-466-05 | 69168-466 | Allegiant Health | 500 TABLET, FILM COATED in 1 BOTTLE (69168-466-05) | April 16, 2025 |
| 72288-080-09 | 72288-080 | Amazon.com Services LLC | 50 POUCH in 1 CARTON (72288-080-09) / 2 TABLET, FILM COATED in 1 POUCH (72288-080-54) | July 23, 2026 |
| 72288-143-78 | 72288-143 | Amazon.com Services LLC | 1 BOTTLE in 1 CARTON (72288-143-78) / 100 TABLET, FILM COATED in 1 BOTTLE (72288-143-00) | July 30, 2026 |
| 72288-143-90 | 72288-143 | Amazon.com Services LLC | 500 TABLET, FILM COATED in 1 BOTTLE (72288-143-90) | September 3, 2026 |
| 69238-1101-5 | 69238-1101 | Amneal Pharmaceuticals NY LLC | 500 TABLET, FILM COATED in 1 BOTTLE (69238-1101-5) | April 1, 2014 |
| 69238-1102-5 | 69238-1102 | Amneal Pharmaceuticals NY LLC | 500 TABLET, FILM COATED in 1 BOTTLE (69238-1102-5) | April 1, 2014 |
| 69238-1103-5 | 69238-1103 | Amneal Pharmaceuticals NY LLC | 500 TABLET, FILM COATED in 1 BOTTLE (69238-1103-5) | April 1, 2014 |
| 71610-222-60 | 71610-222 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-222-60) | January 14, 2019 |
| 71610-222-80 | 71610-222 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-222-80) | January 14, 2019 |
| 71610-222-92 | 71610-222 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-222-92) | January 14, 2019 |
| 71610-532-60 | 71610-532 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-532-60) | March 9, 2021 |
| 71610-532-80 | 71610-532 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-532-80) | March 9, 2021 |
| 71610-532-92 | 71610-532 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-532-92) | March 9, 2021 |
| 71610-629-60 | 71610-629 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-60) | December 17, 2021 |
| 71610-629-80 | 71610-629 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-80) | December 17, 2021 |
| 71610-629-92 | 71610-629 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71610-629-92) | January 14, 2022 |
| 71610-890-60 | 71610-890 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-890-60) | March 21, 2025 |
| 71610-890-80 | 71610-890 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-890-80) | March 21, 2025 |
| 71610-895-60 | 71610-895 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-895-60) | April 1, 2025 |
| 71610-895-70 | 71610-895 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-895-70) | April 1, 2025 |
| 71610-895-80 | 71610-895 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-895-80) | April 1, 2025 |
| 71610-895-92 | 71610-895 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-895-92) | April 1, 2025 |
| 71610-901-60 | 71610-901 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-901-60) | May 1, 2025 |
| 71610-901-70 | 71610-901 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-901-70) | May 1, 2025 |
| 71610-901-80 | 71610-901 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-901-80) | May 1, 2025 |
| 71610-901-92 | 71610-901 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-901-92) | May 1, 2025 |
| 71610-902-53 | 71610-902 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (71610-902-53) | May 1, 2025 |
| 71610-902-60 | 71610-902 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-902-60) | May 1, 2025 |
| 71610-902-70 | 71610-902 | Aphena Pharma Solutions - Tennessee, LLC | 120 TABLET, FILM COATED in 1 BOTTLE (71610-902-70) | May 1, 2025 |
| 71610-902-80 | 71610-902 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-902-80) | May 1, 2025 |
| 71610-902-92 | 71610-902 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-902-92) | May 1, 2025 |
| 71610-916-60 | 71610-916 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (71610-916-60) | June 24, 2025 |
| 71610-916-80 | 71610-916 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, FILM COATED in 1 BOTTLE (71610-916-80) | June 24, 2025 |
| 71610-916-92 | 71610-916 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET, FILM COATED in 1 BOTTLE (71610-916-92) | June 24, 2025 |
| 67877-319-01 | 67877-319 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-319-01) | December 21, 2015 |
| 67877-319-05 | 67877-319 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-319-05) | December 21, 2015 |
| 67877-319-29 | 67877-319 | Ascend Laboratories, LLC | 21000 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-319-29) | April 14, 2017 |
| 67877-319-30 | 67877-319 | Ascend Laboratories, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (67877-319-30) | December 21, 2015 |
| 67877-319-50 | 67877-319 | Ascend Laboratories, LLC | 50 TABLET, FILM COATED in 1 BOTTLE (67877-319-50) | December 21, 2015 |
| 67877-320-01 | 67877-320 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-320-01) | December 21, 2015 |
| 67877-320-05 | 67877-320 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-320-05) | December 21, 2015 |
| 67877-320-28 | 67877-320 | Ascend Laboratories, LLC | 15000 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-320-28) | April 14, 2017 |
| 67877-320-30 | 67877-320 | Ascend Laboratories, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (67877-320-30) | December 21, 2015 |
| 67877-320-50 | 67877-320 | Ascend Laboratories, LLC | 50 TABLET, FILM COATED in 1 BOTTLE (67877-320-50) | December 21, 2015 |
| 67877-321-01 | 67877-321 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-321-01) | December 21, 2015 |
| 67877-321-05 | 67877-321 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-321-05) | December 21, 2015 |
| 67877-321-27 | 67877-321 | Ascend Laboratories, LLC | 11400 TABLET, FILM COATED in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (67877-321-27) | April 14, 2017 |
| 67877-321-30 | 67877-321 | Ascend Laboratories, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (67877-321-30) | December 21, 2015 |
| 67877-321-50 | 67877-321 | Ascend Laboratories, LLC | 50 TABLET, FILM COATED in 1 BOTTLE (67877-321-50) | December 21, 2015 |
| 67877-737-01 | 67877-737 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-737-01) | September 15, 2026 |
| 67877-737-05 | 67877-737 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-737-05) | September 15, 2026 |
| 67877-737-33 | 67877-737 | Ascend Laboratories, LLC | 1 BLISTER PACK in 1 CARTON (67877-737-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK | September 15, 2026 |
| 67877-737-90 | 67877-737 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-737-90) | September 15, 2026 |
| 67877-738-01 | 67877-738 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-738-01) | September 15, 2026 |
| 67877-738-05 | 67877-738 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-738-05) | September 15, 2026 |
| 67877-738-30 | 67877-738 | Ascend Laboratories, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (67877-738-30) | September 15, 2026 |
| 67877-738-33 | 67877-738 | Ascend Laboratories, LLC | 1 BLISTER PACK in 1 CARTON (67877-738-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK | September 15, 2026 |
| 67877-738-50 | 67877-738 | Ascend Laboratories, LLC | 50 TABLET, FILM COATED in 1 BOTTLE (67877-738-50) | September 15, 2026 |
| 67877-738-90 | 67877-738 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-738-90) | September 15, 2026 |
| 67877-739-01 | 67877-739 | Ascend Laboratories, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (67877-739-01) | September 15, 2026 |
| 67877-739-05 | 67877-739 | Ascend Laboratories, LLC | 500 TABLET, FILM COATED in 1 BOTTLE (67877-739-05) | September 15, 2026 |
| 67877-739-30 | 67877-739 | Ascend Laboratories, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (67877-739-30) | September 15, 2026 |
| 67877-739-33 | 67877-739 | Ascend Laboratories, LLC | 1 BLISTER PACK in 1 CARTON (67877-739-33) / 10 TABLET, FILM COATED in 1 BLISTER PACK | September 15, 2026 |
| 67877-739-50 | 67877-739 | Ascend Laboratories, LLC | 50 TABLET, FILM COATED in 1 BOTTLE (67877-739-50) | September 15, 2026 |
| 67877-739-60 | 67877-739 | Ascend Laboratories, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (67877-739-60) | September 15, 2026 |
| 67877-739-90 | 67877-739 | Ascend Laboratories, LLC | 90 TABLET, FILM COATED in 1 BOTTLE (67877-739-90) | September 15, 2026 |
| 76420-846-01 | 76420-846 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-846-01) | September 8, 2024 |
| 76420-846-05 | 76420-846 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-846-05) | September 8, 2024 |
| 76420-846-30 | 76420-846 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-846-30) | September 8, 2024 |
| 76420-846-60 | 76420-846 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-846-60) | September 8, 2024 |
| 76420-846-90 | 76420-846 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-846-90) | September 8, 2024 |
| 76420-847-01 | 76420-847 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-847-01) | September 8, 2024 |
| 76420-847-05 | 76420-847 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-847-05) | September 8, 2024 |
| 76420-847-30 | 76420-847 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-847-30) | September 8, 2024 |
| 76420-847-60 | 76420-847 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-847-60) | September 8, 2024 |
| 76420-847-90 | 76420-847 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-847-90) | September 8, 2024 |
| 76420-848-01 | 76420-848 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-848-01) | September 8, 2024 |
| 76420-848-05 | 76420-848 | Asclemed USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (76420-848-05) | September 8, 2024 |
| 76420-848-30 | 76420-848 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-848-30) | September 8, 2024 |
| 76420-848-60 | 76420-848 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-848-60) | September 8, 2024 |
| 76420-848-90 | 76420-848 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-848-90) | September 8, 2024 |
| 21130-393-14 | 21130-393 | Better Living Brands, LLC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (21130-393-14) | March 1, 1999 |
| 70729-291-12 | 70729-291 | Breeden Brothers, LLC | 1 BOTTLE, PLASTIC in 1 CARTON (70729-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 73614-201-03 | 73614-201 | Brisk Pharmaceuticals | 30 TABLET, FILM COATED in 1 BOTTLE (73614-201-03) | February 10, 2025 |
| 63629-1467-0 | 63629-1467 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-1467-0) | November 20, 2013 |
| 63629-1467-1 | 63629-1467 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (63629-1467-1) | July 15, 2005 |
| 63629-1467-2 | 63629-1467 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (63629-1467-2) | June 19, 2017 |
| 63629-1467-3 | 63629-1467 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (63629-1467-3) | January 17, 2005 |
| 63629-1467-4 | 63629-1467 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (63629-1467-4) | February 21, 2006 |
| 63629-1467-5 | 63629-1467 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (63629-1467-5) | February 10, 2006 |
| 63629-1467-6 | 63629-1467 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (63629-1467-6) | January 15, 2009 |
| 63629-1467-7 | 63629-1467 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (63629-1467-7) | June 6, 2008 |
| 63629-1467-8 | 63629-1467 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (63629-1467-8) | June 14, 2010 |
| 63629-1467-9 | 63629-1467 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (63629-1467-9) | October 29, 2010 |
| 63629-7676-1 | 63629-7676 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (63629-7676-1) | July 25, 2018 |
| 63629-7676-2 | 63629-7676 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (63629-7676-2) | February 5, 2019 |
| 63629-7676-3 | 63629-7676 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (63629-7676-3) | June 15, 2018 |
| 71335-0690-1 | 71335-0690 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-0690-1) | February 1, 2019 |
| 71335-0690-2 | 71335-0690 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-0690-2) | February 19, 2018 |
| 71335-0690-3 | 71335-0690 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-0690-3) | February 27, 2018 |
| 71335-0690-4 | 71335-0690 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-0690-4) | February 26, 2018 |
| 71335-0690-5 | 71335-0690 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-0690-5) | July 26, 2018 |
| 71335-0690-6 | 71335-0690 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-0690-6) | April 5, 2018 |
| 71335-0690-7 | 71335-0690 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-0690-7) | December 27, 2021 |
| 71335-0690-8 | 71335-0690 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-0690-8) | August 21, 2018 |
| 71335-0690-9 | 71335-0690 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-0690-9) | February 20, 2018 |
| 71335-1073-0 | 71335-1073 | Bryant Ranch Prepack | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1073-0) | December 28, 2021 |
| 71335-1073-1 | 71335-1073 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1073-1) | February 14, 2019 |
| 71335-1073-2 | 71335-1073 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1073-2) | February 13, 2019 |
| 71335-1073-3 | 71335-1073 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1073-3) | February 26, 2019 |
| 71335-1073-4 | 71335-1073 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1073-4) | February 14, 2019 |
| 71335-1073-5 | 71335-1073 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1073-5) | June 6, 2019 |
| 71335-1073-6 | 71335-1073 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1073-6) | February 21, 2019 |
| 71335-1073-7 | 71335-1073 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1073-7) | February 19, 2019 |
| 71335-1073-8 | 71335-1073 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1073-8) | July 18, 2019 |
| 71335-1073-9 | 71335-1073 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1073-9) | February 27, 2019 |
| 71335-1206-0 | 71335-1206 | Bryant Ranch Prepack | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1206-0) | May 6, 2019 |
| 71335-1206-1 | 71335-1206 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1206-1) | September 5, 2019 |
| 71335-1206-2 | 71335-1206 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1206-2) | May 6, 2019 |
| 71335-1206-3 | 71335-1206 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1206-3) | September 10, 2019 |
| 71335-1206-4 | 71335-1206 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1206-4) | September 25, 2019 |
| 71335-1206-5 | 71335-1206 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1206-5) | May 8, 2019 |
| 71335-1206-6 | 71335-1206 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1206-6) | October 14, 2019 |
| 71335-1206-7 | 71335-1206 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1206-7) | October 10, 2019 |
| 71335-1206-8 | 71335-1206 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1206-8) | May 6, 2019 |
| 71335-1206-9 | 71335-1206 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1206-9) | May 6, 2019 |
| 71335-1207-0 | 71335-1207 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1207-0) | October 30, 2019 |
| 71335-1207-1 | 71335-1207 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1207-1) | December 26, 2019 |
| 71335-1207-2 | 71335-1207 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1207-2) | September 4, 2020 |
| 71335-1207-3 | 71335-1207 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1207-3) | May 6, 2019 |
| 71335-1207-4 | 71335-1207 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1207-4) | July 29, 2020 |
| 71335-1207-5 | 71335-1207 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1207-5) | April 15, 2019 |
| 71335-1207-6 | 71335-1207 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1207-6) | November 20, 2019 |
| 71335-1207-7 | 71335-1207 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1207-7) | September 4, 2020 |
| 71335-1207-8 | 71335-1207 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1207-8) | September 4, 2020 |
| 71335-1207-9 | 71335-1207 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1207-9) | January 22, 2020 |
| 71335-1218-0 | 71335-1218 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1218-0) | February 9, 2022 |
| 71335-1218-1 | 71335-1218 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1218-1) | February 9, 2022 |
| 71335-1218-2 | 71335-1218 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1218-2) | February 9, 2022 |
| 71335-1218-3 | 71335-1218 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1218-3) | February 9, 2022 |
| 71335-1218-4 | 71335-1218 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1218-4) | February 9, 2022 |
| 71335-1218-5 | 71335-1218 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1218-5) | February 9, 2022 |
| 71335-1218-6 | 71335-1218 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1218-6) | February 9, 2022 |
| 71335-1218-7 | 71335-1218 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1218-7) | February 9, 2022 |
| 71335-1218-8 | 71335-1218 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1218-8) | February 9, 2022 |
| 71335-1218-9 | 71335-1218 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1218-9) | February 9, 2022 |
| 71335-1270-1 | 71335-1270 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1270-1) | February 9, 2020 |
| 71335-1270-2 | 71335-1270 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1270-2) | February 9, 2020 |
| 71335-1270-3 | 71335-1270 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1270-3) | February 9, 2020 |
| 71335-1270-4 | 71335-1270 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1270-4) | February 9, 2020 |
| 71335-1270-5 | 71335-1270 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1270-5) | February 9, 2020 |
| 71335-1270-6 | 71335-1270 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1270-6) | February 9, 2020 |
| 71335-1270-7 | 71335-1270 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1270-7) | February 9, 2020 |
| 71335-1270-8 | 71335-1270 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1270-8) | February 9, 2020 |
| 71335-1270-9 | 71335-1270 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1270-9) | February 9, 2020 |
| 71335-1396-0 | 71335-1396 | Bryant Ranch Prepack | 84 TABLET, FILM COATED in 1 BOTTLE (71335-1396-0) | November 18, 2019 |
| 71335-1396-1 | 71335-1396 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1396-1) | November 18, 2019 |
| 71335-1396-2 | 71335-1396 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1396-2) | November 18, 2019 |
| 71335-1396-3 | 71335-1396 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1396-3) | November 18, 2019 |
| 71335-1396-4 | 71335-1396 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1396-4) | November 18, 2019 |
| 71335-1396-5 | 71335-1396 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1396-5) | November 18, 2019 |
| 71335-1396-6 | 71335-1396 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1396-6) | November 18, 2019 |
| 71335-1396-7 | 71335-1396 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1396-7) | November 18, 2019 |
| 71335-1396-8 | 71335-1396 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1396-8) | November 18, 2019 |
| 71335-1396-9 | 71335-1396 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1396-9) | November 18, 2019 |
| 71335-1503-0 | 71335-1503 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1503-0) | February 12, 2020 |
| 71335-1503-1 | 71335-1503 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1503-1) | February 12, 2020 |
| 71335-1503-2 | 71335-1503 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1503-2) | February 12, 2020 |
| 71335-1503-3 | 71335-1503 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1503-3) | February 12, 2020 |
| 71335-1503-4 | 71335-1503 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1503-4) | February 12, 2020 |
| 71335-1503-5 | 71335-1503 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1503-5) | February 12, 2020 |
| 71335-1503-6 | 71335-1503 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1503-6) | February 12, 2020 |
| 71335-1503-7 | 71335-1503 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1503-7) | February 12, 2020 |
| 71335-1503-8 | 71335-1503 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1503-8) | February 12, 2020 |
| 71335-1503-9 | 71335-1503 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1503-9) | February 12, 2020 |
| 71335-1517-1 | 71335-1517 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1517-1) | February 20, 2020 |
| 71335-1517-2 | 71335-1517 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1517-2) | February 20, 2020 |
| 71335-1517-3 | 71335-1517 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1517-3) | February 20, 2020 |
| 71335-1517-4 | 71335-1517 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1517-4) | February 20, 2020 |
| 71335-1517-5 | 71335-1517 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1517-5) | February 20, 2020 |
| 71335-1517-6 | 71335-1517 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1517-6) | February 20, 2020 |
| 71335-1517-7 | 71335-1517 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1517-7) | February 20, 2020 |
| 71335-1517-8 | 71335-1517 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-1517-8) | February 20, 2020 |
| 71335-1517-9 | 71335-1517 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1517-9) | February 20, 2020 |
| 71335-1911-0 | 71335-1911 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1911-0) | July 15, 2021 |
| 71335-1911-1 | 71335-1911 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-1911-1) | July 15, 2021 |
| 71335-1911-2 | 71335-1911 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-1911-2) | July 15, 2021 |
| 71335-1911-3 | 71335-1911 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1911-3) | July 15, 2021 |
| 71335-1911-4 | 71335-1911 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1911-4) | July 15, 2021 |
| 71335-1911-5 | 71335-1911 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1911-5) | July 15, 2021 |
| 71335-1911-6 | 71335-1911 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-1911-6) | July 15, 2021 |
| 71335-1911-7 | 71335-1911 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-1911-7) | July 15, 2021 |
| 71335-1911-8 | 71335-1911 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1911-8) | July 15, 2021 |
| 71335-1911-9 | 71335-1911 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-1911-9) | July 15, 2021 |
| 71335-2068-0 | 71335-2068 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2068-0) | March 29, 2022 |
| 71335-2068-1 | 71335-2068 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2068-1) | March 29, 2022 |
| 71335-2068-2 | 71335-2068 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2068-2) | March 29, 2022 |
| 71335-2068-3 | 71335-2068 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2068-3) | March 29, 2022 |
| 71335-2068-4 | 71335-2068 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2068-4) | March 29, 2022 |
| 71335-2068-5 | 71335-2068 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2068-5) | March 29, 2022 |
| 71335-2068-6 | 71335-2068 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-2068-6) | March 29, 2022 |
| 71335-2068-7 | 71335-2068 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-2068-7) | March 29, 2022 |
| 71335-2068-8 | 71335-2068 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2068-8) | March 29, 2022 |
| 71335-2068-9 | 71335-2068 | Bryant Ranch Prepack | 56 TABLET, FILM COATED in 1 BOTTLE (71335-2068-9) | March 29, 2022 |
| 71335-3108-1 | 71335-3108 | Bryant Ranch Prepack | 500 TABLET, FILM COATED in 1 BOTTLE (71335-3108-1) | March 30, 2026 |
| 71335-3121-0 | 71335-3121 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE (71335-3121-0) | April 13, 2026 |
| 71335-3121-1 | 71335-3121 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-3121-1) | April 13, 2026 |
| 71335-3121-2 | 71335-3121 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-3121-2) | April 13, 2026 |
| 71335-3121-3 | 71335-3121 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3121-3) | April 13, 2026 |
| 71335-3121-4 | 71335-3121 | Bryant Ranch Prepack | 40 TABLET, FILM COATED in 1 BOTTLE (71335-3121-4) | April 13, 2026 |
| 71335-3121-5 | 71335-3121 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-3121-5) | April 13, 2026 |
| 71335-3121-6 | 71335-3121 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3121-6) | April 13, 2026 |
| 71335-3121-7 | 71335-3121 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-3121-7) | April 13, 2026 |
| 71335-3121-8 | 71335-3121 | Bryant Ranch Prepack | 50 TABLET, FILM COATED in 1 BOTTLE (71335-3121-8) | April 13, 2026 |
| 71335-3121-9 | 71335-3121 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3121-9) | April 13, 2026 |
| 83615-0001-3 | 83615-0001 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (83615-0001-3) | August 23, 2023 |
| 63868-773-05 | 63868-773 | CHAIN DRUG MARKETING ASSOCIATION INC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63868-773-05) | May 24, 1988 |
| 63868-773-10 | 63868-773 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-773-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63868-773-24 | 63868-773 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-773-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63868-773-50 | 63868-773 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-773-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63868-979-10 | 63868-979 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63868-979-24 | 63868-979 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63868-979-50 | 63868-979 | CHAIN DRUG MARKETING ASSOCIATION INC | 1 BOTTLE, PLASTIC in 1 CARTON (63868-979-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 63981-291-14 | 63981-291 | COSTCO WHOLESALE CORPORATION | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-291-14) | May 24, 1988 |
| 63981-393-14 | 63981-393 | COSTCO WHOLESALE CORPORATION | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (63981-393-14) | March 1, 1999 |
| 59779-291-10 | 59779-291 | CVS Pharmacy | 1 BOTTLE in 1 PACKAGE (59779-291-10) / 10 TABLET, FILM COATED in 1 BOTTLE | May 24, 1988 |
| 59779-291-98 | 59779-291 | CVS Pharmacy | 2 BOTTLE in 1 PACKAGE (59779-291-98) / 10 TABLET, FILM COATED in 1 BOTTLE | May 24, 1988 |
| 59779-438-12 | 59779-438 | CVS Pharmacy | 1 BOTTLE, PLASTIC in 1 CARTON (59779-438-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | March 1, 1999 |
| 59779-517-71 | 59779-517 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-517-71) / 50 TABLET, FILM COATED in 1 BOTTLE | April 27, 2006 |
| 59779-517-78 | 59779-517 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-517-78) / 100 TABLET, FILM COATED in 1 BOTTLE | April 27, 2006 |
| 59779-604-00 | 59779-604 | CVS Pharmacy | 2 BOTTLE in 1 PACKAGE (59779-604-00) / 500 TABLET, FILM COATED in 1 BOTTLE | April 15, 2025 |
| 59779-604-62 | 59779-604 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-604-62) / 24 TABLET, FILM COATED in 1 BOTTLE | July 31, 2001 |
| 59779-604-71 | 59779-604 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-604-71) / 50 TABLET, FILM COATED in 1 BOTTLE | July 31, 2001 |
| 59779-604-78 | 59779-604 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-604-78) / 100 TABLET, FILM COATED in 1 BOTTLE | July 31, 2001 |
| 59779-604-82 | 59779-604 | CVS Pharmacy | 2 BOTTLE in 1 CARTON (59779-604-82) / 100 TABLET, FILM COATED in 1 BOTTLE | March 3, 2010 |
| 59779-604-90 | 59779-604 | CVS Pharmacy | 500 TABLET, FILM COATED in 1 BOTTLE (59779-604-90) | July 10, 2001 |
| 59779-647-71 | 59779-647 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-647-71) / 50 TABLET, FILM COATED in 1 BOTTLE | July 31, 2001 |
| 59779-647-78 | 59779-647 | CVS Pharmacy | 1 BOTTLE in 1 CARTON (59779-647-78) / 100 TABLET, FILM COATED in 1 BOTTLE | August 2, 2001 |
| 59779-647-90 | 59779-647 | CVS Pharmacy | 500 TABLET, FILM COATED in 1 BOTTLE (59779-647-90) | March 28, 2007 |
| 59779-647-93 | 59779-647 | CVS Pharmacy | 2 BOTTLE in 1 PACKAGE (59779-647-93) / 500 TABLET, FILM COATED in 1 BOTTLE | June 10, 2025 |
| 55154-0669-0 | 55154-0669 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-0669-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | June 3, 2011 |
| 55154-0741-0 | 55154-0741 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-0741-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | June 10, 2009 |
| 55154-1342-0 | 55154-1342 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-1342-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | June 10, 2009 |
| 55154-1380-0 | 55154-1380 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-1380-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK | June 10, 2009 |
| 70000-0291-1 | 70000-0291 | Cardinal Health 110, LLC. DBA Leader | 1 BOTTLE, PLASTIC in 1 CARTON (70000-0291-1) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | March 1, 1999 |
| 68016-634-00 | 68016-634 | Chain Drug Consortium | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-00) | May 24, 1988 |
| 68016-634-05 | 68016-634 | Chain Drug Consortium | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-05) | May 24, 1988 |
| 68016-634-10 | 68016-634 | Chain Drug Consortium | 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-10) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 68016-634-24 | 68016-634 | Chain Drug Consortium | 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 68016-634-25 | 68016-634 | Chain Drug Consortium | 250 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68016-634-25) | May 24, 1988 |
| 68016-634-50 | 68016-634 | Chain Drug Consortium | 1 BOTTLE, PLASTIC in 1 CARTON (68016-634-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 83324-056-01 | 83324-056 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-056-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | August 13, 2024 |
| 83324-056-24 | 83324-056 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-056-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | August 13, 2024 |
| 83324-056-50 | 83324-056 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-056-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | August 13, 2024 |
| 83324-059-01 | 83324-059 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-059-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | September 17, 2024 |
| 83324-059-24 | 83324-059 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-059-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | September 17, 2024 |
| 83324-059-50 | 83324-059 | Chain Drug Marketing Association, Inc. | 1 BOTTLE, PLASTIC in 1 CARTON (83324-059-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | September 17, 2024 |
| 62135-400-12 | 62135-400 | Chartwell RX, LLC | 120 TABLET, FILM COATED in 1 PACKAGE (62135-400-12) | August 10, 2022 |
| 62135-401-12 | 62135-401 | Chartwell RX, LLC | 120 TABLET, FILM COATED in 1 PACKAGE (62135-401-12) | August 10, 2022 |
| 62135-402-12 | 62135-402 | Chartwell RX, LLC | 120 TABLET, FILM COATED in 1 PACKAGE (62135-402-12) | August 10, 2022 |
| 67046-1606-3 | 67046-1606 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1606-3) | October 13, 2025 |
| 67046-1646-3 | 67046-1646 | Coupler LLC | 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1646-3) | January 12, 2026 |
| 72189-231-21 | 72189-231 | DIRECT RX | 21 TABLET, FILM COATED in 1 BOTTLE (72189-231-21) | June 4, 2021 |
| 72189-231-30 | 72189-231 | DIRECT RX | 30 TABLET, FILM COATED in 1 BOTTLE (72189-231-30) | June 4, 2021 |
| 72189-231-60 | 72189-231 | DIRECT RX | 60 TABLET, FILM COATED in 1 BOTTLE (72189-231-60) | June 4, 2021 |
| 72189-231-90 | 72189-231 | DIRECT RX | 90 TABLET, FILM COATED in 1 BOTTLE (72189-231-90) | June 4, 2021 |
| 72189-266-15 | 72189-266 | DIRECT RX | 15 TABLET, FILM COATED in 1 BOTTLE (72189-266-15) | September 16, 2021 |
| 72189-266-30 | 72189-266 | DIRECT RX | 30 TABLET, FILM COATED in 1 BOTTLE (72189-266-30) | September 16, 2021 |
| 72189-266-40 | 72189-266 | DIRECT RX | 40 TABLET, FILM COATED in 1 BOTTLE (72189-266-40) | September 16, 2021 |
| 72189-266-60 | 72189-266 | DIRECT RX | 60 TABLET, FILM COATED in 1 BOTTLE (72189-266-60) | September 16, 2021 |
| 72189-266-71 | 72189-266 | DIRECT RX | 100 TABLET, FILM COATED in 1 BOTTLE (72189-266-71) | September 16, 2021 |
| 72189-266-72 | 72189-266 | DIRECT RX | 120 TABLET, FILM COATED in 1 BOTTLE (72189-266-72) | September 16, 2021 |
| 72189-266-90 | 72189-266 | DIRECT RX | 90 TABLET, FILM COATED in 1 BOTTLE (72189-266-90) | September 16, 2021 |
| 55910-791-08 | 55910-791 | DOLGENCORP, LLC | 1 BOTTLE, PLASTIC in 1 CARTON (55910-791-08) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 12, 2023 |
| 55910-791-96 | 55910-791 | DOLGENCORP, LLC | 2 BOTTLE, PLASTIC in 1 CARTON (55910-791-96) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 12, 2023 |
| 72189-324-30 | 72189-324 | Direct Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-324-30) | February 21, 2022 |
| 72189-324-60 | 72189-324 | Direct Rx | 60 TABLET, FILM COATED in 1 BOTTLE (72189-324-60) | February 21, 2022 |
| 61919-463-15 | 61919-463 | Direct_Rx | 15 TABLET, FILM COATED in 1 BOTTLE (61919-463-15) | August 22, 2019 |
| 61919-463-21 | 61919-463 | Direct_Rx | 21 TABLET, FILM COATED in 1 BOTTLE (61919-463-21) | August 22, 2019 |
| 61919-463-40 | 61919-463 | Direct_Rx | 40 TABLET, FILM COATED in 1 BOTTLE (61919-463-40) | August 22, 2019 |
| 61919-463-45 | 61919-463 | Direct_Rx | 45 TABLET, FILM COATED in 1 BOTTLE (61919-463-45) | August 22, 2019 |
| 61919-463-60 | 61919-463 | Direct_Rx | 60 TABLET, FILM COATED in 1 BOTTLE (61919-463-60) | August 22, 2019 |
| 61919-463-71 | 61919-463 | Direct_Rx | 100 TABLET, FILM COATED in 1 BOTTLE (61919-463-71) | August 22, 2019 |
| 61919-463-72 | 61919-463 | Direct_Rx | 120 TABLET, FILM COATED in 1 BOTTLE (61919-463-72) | August 22, 2019 |
| 61919-463-90 | 61919-463 | Direct_Rx | 90 TABLET, FILM COATED in 1 BOTTLE (61919-463-90) | August 22, 2019 |
| 72189-643-21 | 72189-643 | Direct_Rx | 21 TABLET, FILM COATED in 1 BOTTLE (72189-643-21) | September 30, 2025 |
| 72189-643-30 | 72189-643 | Direct_Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-643-30) | September 30, 2025 |
| 72189-643-60 | 72189-643 | Direct_Rx | 60 TABLET, FILM COATED in 1 BOTTLE (72189-643-60) | September 30, 2025 |
| 72189-643-90 | 72189-643 | Direct_Rx | 90 TABLET, FILM COATED in 1 BOTTLE (72189-643-90) | September 30, 2025 |
| 53943-291-12 | 53943-291 | Discount Drug Mart | 1 BOTTLE, PLASTIC in 1 CARTON (53943-291-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 53943-291-14 | 53943-291 | Discount Drug Mart | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53943-291-14) | May 24, 1988 |
| 53943-291-15 | 53943-291 | Discount Drug Mart | 1 BOTTLE, PLASTIC in 1 CARTON (53943-291-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 53943-292-12 | 53943-292 | Discount Drug Mart | 1 BOTTLE, PLASTIC in 1 CARTON (53943-292-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 53943-292-14 | 53943-292 | Discount Drug Mart | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (53943-292-14) | May 24, 1988 |
| 53943-292-15 | 53943-292 | Discount Drug Mart | 1 BOTTLE, PLASTIC in 1 CARTON (53943-292-15) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC | May 24, 1988 |
| 55910-847-02 | 55910-847 | Dolgencorp, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (55910-847-02) | March 12, 2020 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Orange Book | FDA | Therapeutic equivalence codes, reference drug flags, patents, exclusivity |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 13 sections on this page.