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Diclofenac Sodium
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 |
| Decreased Prostaglandin Production [PE] | PE | All 54 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 |
|---|---|---|---|---|---|---|---|
| 075185-001 | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE | DICLOFENAC SODIUM | Prescription | AB | ||
| 075185-002 | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE | DICLOFENAC SODIUM | Prescription | AB | ||
| 075185-003 | DICLOFENAC SODIUM | TABLET, DELAYED RELEASE | DICLOFENAC SODIUM | Prescription | AB |
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 | 20 | Labeling | Approved | November 21, 2024 | Standard |
| Supplement | 16 | Labeling | Approved | April 29, 2021 | Standard |
| Supplement | 15 | Labeling | Approved | April 29, 2021 | Standard |
| Supplement | 13 | Labeling | Approved | April 20, 2021 | Standard |
| Supplement | 12 | Labeling | Approved | May 9, 2016 | Standard |
| Supplement | 11 | Labeling | Approved | August 24, 2015 | — |
| Supplement | 8 | Labeling | Approved | February 18, 2010 | — |
| Supplement | 5 | Labeling | Approved | February 23, 2006 | — |
| Supplement | 3 | Labeling | Approved | November 19, 2003 | — |
| Original application | 1 | Approved | November 13, 1998 | — |
Review documents
- 0 · Original application · November 13, 1998
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260603). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBoxed Warning WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular 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 WARNINGS). Diclofenac sodium delayed-release tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs cause an increased risk of serious gastrointestinal (GI) 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 and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events (see WARNINGS).
Indications and Usage
openFDA Drug LabelingIndications and Usage INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS: GASTROINTESTINAL BLEEDING, ULCERATION AND PERFORATION). Diclofenac sodium delayed-release tablets are indicated: For relief of the signs and symptoms of osteoarthritis For relief of the signs and symptoms of rheumatoid arthritis For acute or long-term use in the relief of signs and symptoms of ankylosing spondylitis
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ) . After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of osteoarthritis, the recommended dosage is 100 mg/day to 150 mg/day in divided doses (50 mg twice a day or three times a day, or 75 mg twice a day). For the relief of rheumatoid arthritis, the recommended dosage is 150 mg/day to 200 mg/day in divided doses (50 mg three times a day. or four times a day, or 75 mg twice a day). For the relief of ankylosing spondylitis, the recommended dosage is 100 mg/day to 125 mg/day, administered as 25 mg four times a day, with an extra 25-mg dose at bedtime if necessary. Different formulations of diclofenac (diclofenac sodium delayed-release tablets, USP; diclofenac sodium extended-release tablets, USP; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Diclofenac sodium delayed-release tablets are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product (see WARNINGS; Anaphylactic Reactions , Serious Skin Reactions ) . • History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients (see WARNINGS; Anaphylactic Reactions , Exacerbation of Asthma Related to Aspirin Sensitivity ) . • In the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS; Cardiovascular Thrombotic Events ) .
Warnings and Cautions
openFDA Drug LabelingWarnings and Precautions 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 diclofenac, increases the risk of serious gastrointestinal (GI) events ( see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). 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 -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 reinfection, 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 diclofenac sodium delayed-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium delayed-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased risk for …
Warnings
openFDA Drug LabelingWARNINGS 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 diclofenac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). 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 diclofenac in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac is used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year. However, even short-term therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events (see WARNINGS ) GI Bleeding, Ulceration and Perforation (see WARNINGS ) Hepatotoxicity (see WARNINGS ) Hypertension (see WARNINGS ) Heart Failure and Edema (see WARNINGS ) Renal Toxicity and Hyperkalemia (see WARNINGS ) Anaphylactic Reactions (see WARNINGS ) Serious Skin Reactions (see WARNINGS ) Hematologic Toxicity (see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1%-10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal) and vomiting. Abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritus, rashes and tinnitus. Additional adverse experiences reported occasionally include: Body as a Whole: fever, infection, sepsis Cardiovascular System: congestive heart failure, hypertension, tachycardia, syncope Digestive System: dry mouth, esophagitis, gastric/peptic ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis, hepatitis, jaundice Hemic and Lymphatic System: ecchymosis, eosinophilia, leukopenia, melena, purpura, rectal bleeding, stomatitis, thrombocytopenia Metabolic and Nutritional: weight changes Nervous System: anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia,malaise, nervousness, paresthesia, somnolence, tremors, vertigo anxiety, asthenia, confusion, depression, dream abnormalities, drowsiness, insomnia, malaise, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity, sweating increased alopecia, photosensitivity, sweating increased Special Senses: blurred vision blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/ polyuria, proteinuria, renal failure Other adverse reactions, which occur rarely are: Other adverse reactions, which occur rarely are: Body as a Whole: anaphylactic reactions, appetite changes, death Cardiovascular System: arrhythmia, hypotension, myocardial infarction, palpitations, vasculitis Digestive System: colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis colitis, eructation, fulminant hepatitis with and without jaundice, liver failure, liver necrosis, pancreatitis Hemic and Lymphatic System: agranulocytosis, hemolytic anemia, aplastic anemia, lymphadenopathy, pancytopenia Metabolic and Nutritional: hyperglycemia Nervous System: convulsions, coma, hallucinations, meningitis Respiratory System: respiratory depression, pneumonia Skin and appendages: Angioedema, toxic epidermal necrosis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption (FDE), urticaria angioedema, toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption (FDE), urticaria Special Senses: conjunctivitis, hearing impairment
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking diclofenac sodium delayed-release tablets, or other NSAIDs, the most frequently reported adverse experiences occurring in approxi …
Drug Interactions
openFDA Drug LabelingDrug Interactions See Table 2 for clinically significant drug interactions with diclofenac. Table 2. Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of diclofenac sodium delayed-release tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding (see PRECAUTIONS: Hematologic Toxicity ) . Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone (see WARNINGS: Gastrointestinal Bleeding, Ulceration, and Perforation ). Intervention: Concomitant use of diclofenac sodium delayed-release tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see PRECAUTIONS: Hematologic Toxicity ) . Diclofenac sodium delayed-release tablets are not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of diclofenac and ACEinhibitors, ARBs, or betablockers, monitor blood pressure to ensure that the desired blood pressure is obtained. During concomitant use of diclofenac and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function (see WARNINGS: Renal Toxicity and Hyperkalemia ) . When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter. Diuretics Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of diclofenac with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects (see WARNINGS: Renal Toxicity and Hyperkalemia ). Digoxin Clinical Impact: The concomitant use of diclofenac with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin. Intervention: During concomitant use of diclofenac sodium delayed-release tablets and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium delayed-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro . Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Description
openFDA Drug LabelingDESCRIPTION Diclofenac sodium delayed-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium delayed-release tablets, USP are available as enteric-coated tablets of 50 mg (light brown) or 75 mg (pale pink) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following structural formula. The inactive ingredients in diclofenac sodium delayed-release tablets include: crospovidone, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, povidone, simethicone emulsion, sodium hydroxide pellets, talc and titanium dioxide. The 50 mg tablets also contain FD&C Blue #2/Indigo Carmine Aluminum Lake and yellow iron oxide. The 75 mg tablets also contain FD&C Red #40/Allura Red AC Aluminum Lake. The imprinting ink contains the following inactive ingredients: black iron oxide, propylene glycol and shellac glaze. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare. (see WARNINGS; Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hypertension , Renal Toxicity and Hyperkalemia ) . Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg of body weight in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment contact a poison control center (1-800-222-1222).
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Diclofenac sodium delayed-release tablets, USP, for oral administration, are available as: 25 mg: round, light brown, enteric-coated tablets P 25 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 30.......................................NDC 76420-571-30 (repackaged from NDC 16571-203-10) Bottles of 60.......................................NDC 76420-571-60 (repackaged from NDC 16571-203-10) Bottles of 90.......................................NDC 76420-571-90 (repackaged from NDC 16571-203-10) Bottles of 100.....................................NDC 76420-571-01 (relabeled from NDC 16571-203-10) 50 mg: round, light brown, enteric-coated tablets P 50 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 30.......................................NDC 76420-572-30 (repackaged from NDC 16571-202-XX) Bottles of 60.......................................NDC 76420-572-60 (relabeled and repackaged from NDC 16571-202-06) Bottles of 90.......................................NDC 76420-572-90 (repackaged from NDC 16571-202-XX) Bottles of 100.....................................NDC 76420-572-01 (relabeled from NDC 16571-202-10) 75 mg: round, light brown, enteric-coated tablets P 75 imprinted on one side in black ink and plain on the reverse side are supplied as: Bottles of 30.......................................NDC 76420-670-30 (repackaged from NDC 16571-201-XX) Bottles of 60.......................................NDC 76420-670-60 (repackaged/relabeled from NDC 16571-201-XX/NDC 16571-202-06) Bottles of 90.......................................NDC 76420-670-90 (repackaged from NDC 16571-201-XX) Bottles of 100.....................................NDC 76420-670-01 (relabeled from NDC 16571-201-10) Bottles of 500.....................................NDC 76420-670-05 (relabeled from NDC 16571-201-50) Bottles of 1000.....................................NDC 76420-670-00 (relabeled from NDC 16571-201-11) Store at 20° to 25°C (68° to 77°F) (see USP Controlled Room Temperature). Protect from moisture. Dispense in a tight, light-resistant container. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DICLOFENAC SODIUM. 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.
Shortages
Source: FDA Drug Shortages| Status | Availability | Company | Presentation | Updated |
|---|---|---|---|---|
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-06) | August 13, 2026 | |
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-06) | August 13, 2026 | |
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-96) | August 13, 2026 | |
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 50 mg (NDC 0228-2550-11) | August 13, 2026 | |
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-96) | August 13, 2026 | |
| To Be Discontinued | Teva Pharmaceuticals USA, Inc. | Diclofenac Sodium, Tablet, Delayed Release, 75 mg (NDC 0228-2551-11) | August 13, 2026 |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0538-0 | 50090-0538 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-0) | November 28, 2014 |
| 50090-0538-2 | 50090-0538 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-2) | June 29, 2016 |
| 50090-0538-5 | 50090-0538 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0538-5) | June 29, 2016 |
| 50090-0539-1 | 50090-0539 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0539-1) | November 28, 2014 |
| 50090-0540-0 | 50090-0540 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0540-0) | November 28, 2014 |
| 50090-0540-2 | 50090-0540 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0540-2) | November 28, 2014 |
| 50090-0540-5 | 50090-0540 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0540-5) | March 28, 2022 |
| 50090-0541-0 | 50090-0541 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0541-0) | November 28, 2014 |
| 50090-0541-1 | 50090-0541 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0541-1) | November 28, 2014 |
| 50090-0542-0 | 50090-0542 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-0) | November 28, 2014 |
| 50090-0542-2 | 50090-0542 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-2) | November 28, 2014 |
| 50090-0542-5 | 50090-0542 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0542-5) | July 20, 2015 |
| 50090-0545-0 | 50090-0545 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-0) | November 28, 2014 |
| 50090-0545-1 | 50090-0545 | A-S Medication Solutions | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-1) | November 28, 2014 |
| 50090-0545-2 | 50090-0545 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-2) | November 28, 2014 |
| 50090-0545-3 | 50090-0545 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-3) | November 28, 2014 |
| 50090-0545-4 | 50090-0545 | A-S Medication Solutions | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-4) | November 28, 2014 |
| 50090-0545-8 | 50090-0545 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-8) | November 28, 2014 |
| 50090-0545-9 | 50090-0545 | A-S Medication Solutions | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-0545-9) | November 28, 2014 |
| 50090-6924-0 | 50090-6924 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-6924-0) | December 14, 2023 |
| 50090-7646-0 | 50090-7646 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-0) | September 3, 2025 |
| 50090-7646-1 | 50090-7646 | A-S Medication Solutions | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-1) | September 3, 2025 |
| 50090-7646-2 | 50090-7646 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-2) | September 3, 2025 |
| 50090-7646-3 | 50090-7646 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-3) | September 3, 2025 |
| 50090-7646-4 | 50090-7646 | A-S Medication Solutions | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-4) | September 3, 2025 |
| 50090-7646-8 | 50090-7646 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-8) | September 3, 2025 |
| 50090-7646-9 | 50090-7646 | A-S Medication Solutions | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7646-9) | September 3, 2025 |
| 50090-7647-0 | 50090-7647 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7647-0) | September 3, 2025 |
| 50090-7818-0 | 50090-7818 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7818-0) | December 11, 2025 |
| 50090-7838-0 | 50090-7838 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-0) | December 29, 2025 |
| 50090-7838-1 | 50090-7838 | A-S Medication Solutions | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-1) | December 29, 2025 |
| 50090-7838-2 | 50090-7838 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-2) | December 29, 2025 |
| 50090-7838-3 | 50090-7838 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-3) | December 29, 2025 |
| 50090-7838-4 | 50090-7838 | A-S Medication Solutions | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-4) | December 29, 2025 |
| 50090-7838-8 | 50090-7838 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-8) | December 29, 2025 |
| 50090-7838-9 | 50090-7838 | A-S Medication Solutions | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7838-9) | December 29, 2025 |
| 50090-7839-0 | 50090-7839 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7839-0) | December 29, 2025 |
| 50090-7855-0 | 50090-7855 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-0) | January 14, 2026 |
| 50090-7855-1 | 50090-7855 | A-S Medication Solutions | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-1) | January 14, 2026 |
| 50090-7855-2 | 50090-7855 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-2) | January 14, 2026 |
| 50090-7855-3 | 50090-7855 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-3) | January 14, 2026 |
| 50090-7855-4 | 50090-7855 | A-S Medication Solutions | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-4) | January 14, 2026 |
| 50090-7855-8 | 50090-7855 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-8) | January 14, 2026 |
| 50090-7855-9 | 50090-7855 | A-S Medication Solutions | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7855-9) | January 14, 2026 |
| 50090-7856-0 | 50090-7856 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7856-0) | January 14, 2026 |
| 50090-7880-1 | 50090-7880 | A-S Medication Solutions | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7880-1) | February 4, 2026 |
| 50090-7881-0 | 50090-7881 | A-S Medication Solutions | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7881-0) | February 4, 2026 |
| 50090-7881-2 | 50090-7881 | A-S Medication Solutions | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7881-2) | February 4, 2026 |
| 50090-7881-5 | 50090-7881 | A-S Medication Solutions | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-7881-5) | February 4, 2026 |
| 0228-2550-06 | 0228-2550 | Actavis Pharma, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-06) | March 26, 1996 |
| 0228-2550-11 | 0228-2550 | Actavis Pharma, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-11) | March 26, 1996 |
| 0228-2550-96 | 0228-2550 | Actavis Pharma, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2550-96) | March 26, 1996 |
| 0228-2551-06 | 0228-2551 | Actavis Pharma, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2551-06) | March 26, 1996 |
| 0228-2551-11 | 0228-2551 | Actavis Pharma, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2551-11) | March 26, 1996 |
| 0228-2551-96 | 0228-2551 | Actavis Pharma, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0228-2551-96) | March 26, 1996 |
| 72888-109-00 | 72888-109 | Advagen Pharma Ltd | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-00) | June 1, 2023 |
| 72888-109-01 | 72888-109 | Advagen Pharma Ltd | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-01) | June 1, 2023 |
| 72888-109-05 | 72888-109 | Advagen Pharma Ltd | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-05) | August 1, 2023 |
| 72888-109-30 | 72888-109 | Advagen Pharma Ltd | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-30) | June 1, 2023 |
| 72888-109-60 | 72888-109 | Advagen Pharma Ltd | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-109-60) | June 1, 2023 |
| 72888-110-00 | 72888-110 | Advagen Pharma Ltd | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-110-00) | September 27, 2023 |
| 72888-110-01 | 72888-110 | Advagen Pharma Ltd | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-110-01) | June 1, 2023 |
| 72888-110-05 | 72888-110 | Advagen Pharma Ltd | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-110-05) | August 1, 2023 |
| 72888-110-30 | 72888-110 | Advagen Pharma Ltd | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-110-30) | June 1, 2023 |
| 72888-110-60 | 72888-110 | Advagen Pharma Ltd | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-110-60) | June 1, 2023 |
| 72888-111-00 | 72888-111 | Advagen Pharma Ltd | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-00) | June 1, 2023 |
| 72888-111-01 | 72888-111 | Advagen Pharma Ltd | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-01) | June 1, 2023 |
| 72888-111-05 | 72888-111 | Advagen Pharma Ltd | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-05) | August 1, 2023 |
| 72888-111-30 | 72888-111 | Advagen Pharma Ltd | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-30) | June 1, 2023 |
| 72888-111-60 | 72888-111 | Advagen Pharma Ltd | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72888-111-60) | June 1, 2023 |
| 80425-0055-1 | 80425-0055 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0055-1) | November 13, 1998 |
| 80425-0189-1 | 80425-0189 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-1) | November 13, 1998 |
| 80425-0189-2 | 80425-0189 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-2) | November 13, 1998 |
| 80425-0189-3 | 80425-0189 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0189-3) | November 13, 1998 |
| 80425-0197-2 | 80425-0197 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-2) | October 27, 2023 |
| 80425-0197-3 | 80425-0197 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0197-3) | October 27, 2023 |
| 80425-0102-2 | 80425-0102 | Advanced Rx of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0102-2) | December 31, 2010 |
| 80425-0102-3 | 80425-0102 | Advanced Rx of Tennessee, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0102-3) | December 31, 2010 |
| 80425-0564-1 | 80425-0564 | Advanced Rx of Tennessee, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-1) | December 5, 2025 |
| 80425-0564-2 | 80425-0564 | Advanced Rx of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-2) | December 5, 2025 |
| 80425-0564-3 | 80425-0564 | Advanced Rx of Tennessee, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0564-3) | December 5, 2025 |
| 80425-0569-1 | 80425-0569 | Advanced Rx of Tennessee, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-1) | January 5, 2026 |
| 80425-0569-2 | 80425-0569 | Advanced Rx of Tennessee, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80425-0569-2) | January 5, 2026 |
| 60687-606-01 | 60687-606 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-606-01) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-606-11) | June 7, 2022 |
| 60687-658-01 | 60687-658 | American Health Packaging | 100 BLISTER PACK in 1 CARTON (60687-658-01) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-658-11) | August 22, 2022 |
| 71610-068-80 | 71610-068 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (71610-068-80) | May 14, 2018 |
| 76420-571-01 | 76420-571 | Asclemed USA, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-01) | March 7, 2024 |
| 76420-571-30 | 76420-571 | Asclemed USA, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-30) | March 7, 2024 |
| 76420-571-60 | 76420-571 | Asclemed USA, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-60) | March 7, 2024 |
| 76420-571-90 | 76420-571 | Asclemed USA, Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-571-90) | March 7, 2024 |
| 76420-572-01 | 76420-572 | Asclemed USA, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-01) | March 7, 2024 |
| 76420-572-30 | 76420-572 | Asclemed USA, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-30) | March 7, 2024 |
| 76420-572-60 | 76420-572 | Asclemed USA, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-60) | March 7, 2024 |
| 76420-572-90 | 76420-572 | Asclemed USA, Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-572-90) | March 7, 2024 |
| 76420-670-00 | 76420-670 | Asclemed USA, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-00) | March 25, 2026 |
| 76420-670-01 | 76420-670 | Asclemed USA, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-01) | March 7, 2024 |
| 76420-670-05 | 76420-670 | Asclemed USA, Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-05) | March 25, 2026 |
| 76420-670-30 | 76420-670 | Asclemed USA, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-30) | March 7, 2024 |
| 76420-670-60 | 76420-670 | Asclemed USA, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-60) | March 7, 2024 |
| 76420-670-90 | 76420-670 | Asclemed USA, Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (76420-670-90) | March 7, 2024 |
| 59651-842-01 | 59651-842 | Aurobindo Pharma Limited | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-842-01) | April 17, 2025 |
| 59651-842-60 | 59651-842 | Aurobindo Pharma Limited | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-842-60) | April 17, 2025 |
| 59651-842-99 | 59651-842 | Aurobindo Pharma Limited | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-842-99) | April 17, 2025 |
| 59651-843-01 | 59651-843 | Aurobindo Pharma Limited | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-01) | April 17, 2025 |
| 59651-843-05 | 59651-843 | Aurobindo Pharma Limited | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-05) | April 17, 2025 |
| 59651-843-60 | 59651-843 | Aurobindo Pharma Limited | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-60) | April 17, 2025 |
| 59651-843-99 | 59651-843 | Aurobindo Pharma Limited | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-843-99) | April 17, 2025 |
| 42291-230-10 | 42291-230 | AvKARE | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-230-10) | September 22, 2011 |
| 42291-231-10 | 42291-231 | AvKARE | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-10) | May 16, 2013 |
| 42291-231-18 | 42291-231 | AvKARE | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-231-18) | March 17, 2011 |
| 68001-279-00 | 68001-279 | BluePoint Laboratories | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-279-00) | December 21, 2015 |
| 68001-280-00 | 68001-280 | BluePoint Laboratories | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-00) | December 21, 2015 |
| 68001-280-06 | 68001-280 | BluePoint Laboratories | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-06) | December 21, 2015 |
| 68001-280-08 | 68001-280 | BluePoint Laboratories | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-280-08) | December 21, 2015 |
| 68001-281-00 | 68001-281 | BluePoint Laboratories | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-00) | December 21, 2015 |
| 68001-281-03 | 68001-281 | BluePoint Laboratories | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-03) | December 21, 2015 |
| 68001-281-06 | 68001-281 | BluePoint Laboratories | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-281-06) | December 21, 2015 |
| 68001-281-08 | 68001-281 | BluePoint Laboratories | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-08) | December 21, 2015 |
| 63629-2010-1 | 63629-2010 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63629-2010-1) | February 16, 2021 |
| 63629-2011-1 | 63629-2011 | Bryant Ranch Prepack | 12 BOTTLE, PLASTIC in 1 BOX (63629-2011-1) / 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 63629-2012-1 | 63629-2012 | Bryant Ranch Prepack | 12 BOTTLE, PLASTIC in 1 BOX (63629-2012-1) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 63629-2013-1 | 63629-2013 | Bryant Ranch Prepack | 24 BOTTLE, PLASTIC in 1 BOX (63629-2013-1) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 63629-2077-1 | 63629-2077 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-2077-1) | February 4, 2021 |
| 63629-3726-1 | 63629-3726 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63629-3726-1) | April 2, 2024 |
| 71335-0357-0 | 71335-0357 | Bryant Ranch Prepack | 40 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-0) | May 4, 2022 |
| 71335-0357-1 | 71335-0357 | Bryant Ranch Prepack | 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-1) | May 4, 2022 |
| 71335-0357-2 | 71335-0357 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-2) | May 4, 2022 |
| 71335-0357-3 | 71335-0357 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-3) | May 4, 2022 |
| 71335-0357-4 | 71335-0357 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-4) | May 4, 2022 |
| 71335-0357-5 | 71335-0357 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-5) | May 4, 2022 |
| 71335-0357-6 | 71335-0357 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-6) | May 4, 2022 |
| 71335-0357-7 | 71335-0357 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-7) | May 4, 2022 |
| 71335-0357-8 | 71335-0357 | Bryant Ranch Prepack | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-8) | May 4, 2022 |
| 71335-0357-9 | 71335-0357 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71335-0357-9) | May 4, 2022 |
| 71335-0456-0 | 71335-0456 | Bryant Ranch Prepack | 40 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-0) | August 24, 2009 |
| 71335-0456-1 | 71335-0456 | Bryant Ranch Prepack | 28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-1) | August 24, 2009 |
| 71335-0456-2 | 71335-0456 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-2) | August 24, 2009 |
| 71335-0456-3 | 71335-0456 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-3) | August 24, 2009 |
| 71335-0456-4 | 71335-0456 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-4) | August 24, 2009 |
| 71335-0456-5 | 71335-0456 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-5) | August 24, 2009 |
| 71335-0456-6 | 71335-0456 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-6) | August 24, 2009 |
| 71335-0456-7 | 71335-0456 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-7) | August 24, 2009 |
| 71335-0456-8 | 71335-0456 | Bryant Ranch Prepack | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-8) | August 24, 2009 |
| 71335-0456-9 | 71335-0456 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0456-9) | August 24, 2009 |
| 71335-0481-1 | 71335-0481 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-1) | May 15, 2018 |
| 71335-0481-2 | 71335-0481 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-2) | February 21, 2018 |
| 71335-0481-3 | 71335-0481 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-3) | February 28, 2018 |
| 71335-0481-4 | 71335-0481 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-4) | June 7, 2018 |
| 71335-0481-5 | 71335-0481 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-5) | April 5, 2022 |
| 71335-0481-6 | 71335-0481 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-6) | May 21, 2018 |
| 71335-0481-7 | 71335-0481 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0481-7) | April 16, 2019 |
| 71335-2543-1 | 71335-2543 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-1) | January 8, 2025 |
| 71335-2543-2 | 71335-2543 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-2) | January 8, 2025 |
| 71335-2543-3 | 71335-2543 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-3) | January 8, 2025 |
| 71335-2543-4 | 71335-2543 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-4) | January 8, 2025 |
| 71335-2543-5 | 71335-2543 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-5) | January 8, 2025 |
| 71335-2543-6 | 71335-2543 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-6) | January 8, 2025 |
| 71335-2543-7 | 71335-2543 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2543-7) | January 8, 2025 |
| 71335-2684-0 | 71335-2684 | Bryant Ranch Prepack | 40 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-0) | February 13, 2026 |
| 71335-2684-1 | 71335-2684 | Bryant Ranch Prepack | 28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-1) | February 13, 2026 |
| 71335-2684-2 | 71335-2684 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-2) | February 13, 2026 |
| 71335-2684-3 | 71335-2684 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-3) | February 13, 2026 |
| 71335-2684-4 | 71335-2684 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-4) | February 13, 2026 |
| 71335-2684-5 | 71335-2684 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-5) | February 13, 2026 |
| 71335-2684-6 | 71335-2684 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-6) | February 13, 2026 |
| 71335-2684-7 | 71335-2684 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-7) | February 13, 2026 |
| 71335-2684-8 | 71335-2684 | Bryant Ranch Prepack | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-8) | February 13, 2026 |
| 71335-2684-9 | 71335-2684 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-2684-9) | February 13, 2026 |
| 72162-1733-0 | 72162-1733 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-0) | August 12, 2024 |
| 72162-1733-1 | 72162-1733 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-1) | August 12, 2024 |
| 72162-1733-2 | 72162-1733 | Bryant Ranch Prepack | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-2) | August 12, 2024 |
| 72162-1733-3 | 72162-1733 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-3) | August 12, 2024 |
| 72162-1733-6 | 72162-1733 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-6) | August 12, 2024 |
| 72162-1733-7 | 72162-1733 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-7) | August 12, 2024 |
| 72162-1733-8 | 72162-1733 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-8) | August 12, 2024 |
| 72162-1733-9 | 72162-1733 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1733-9) | August 12, 2024 |
| 72162-1734-0 | 72162-1734 | Bryant Ranch Prepack | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-0) | May 8, 2023 |
| 72162-1734-1 | 72162-1734 | Bryant Ranch Prepack | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-1) | May 8, 2023 |
| 72162-1734-3 | 72162-1734 | Bryant Ranch Prepack | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-3) | May 8, 2023 |
| 72162-1734-4 | 72162-1734 | Bryant Ranch Prepack | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-4) | May 8, 2023 |
| 72162-1734-5 | 72162-1734 | Bryant Ranch Prepack | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-5) | May 8, 2023 |
| 72162-1734-6 | 72162-1734 | Bryant Ranch Prepack | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-6) | May 8, 2023 |
| 72162-1734-7 | 72162-1734 | Bryant Ranch Prepack | 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-7) | May 8, 2023 |
| 72162-1734-8 | 72162-1734 | Bryant Ranch Prepack | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-8) | May 8, 2023 |
| 72162-1734-9 | 72162-1734 | Bryant Ranch Prepack | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72162-1734-9) | May 8, 2023 |
| 61442-101-01 | 61442-101 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-101-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-101-10 | 61442-101 | Carlsbad Technology, Inc. | 12 BOTTLE, PLASTIC in 1 BOX (61442-101-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-101-60 | 61442-101 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-101-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-102-01 | 61442-102 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-102-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-102-10 | 61442-102 | Carlsbad Technology, Inc. | 12 BOTTLE, PLASTIC in 1 BOX (61442-102-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-102-60 | 61442-102 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-102-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | November 13, 1998 |
| 61442-103-01 | 61442-103 | Carlsbad Technology, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-01) | November 13, 1998 |
| 61442-103-05 | 61442-103 | Carlsbad Technology, Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-05) | November 13, 1998 |
| 61442-103-10 | 61442-103 | Carlsbad Technology, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-10) | November 13, 1998 |
| 61442-103-60 | 61442-103 | Carlsbad Technology, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-103-60) | November 13, 1998 |
| 61442-226-01 | 61442-226 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-226-01) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | March 28, 2025 |
| 61442-226-10 | 61442-226 | Carlsbad Technology, Inc. | 12 BOTTLE, PLASTIC in 1 BOX (61442-226-10) / 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | March 28, 2025 |
| 61442-226-60 | 61442-226 | Carlsbad Technology, Inc. | 24 BOTTLE, PLASTIC in 1 BOX (61442-226-60) / 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC | March 28, 2025 |
| 61442-227-01 | 61442-227 | Carlsbad Technology, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-01) | March 28, 2025 |
| 61442-227-05 | 61442-227 | Carlsbad Technology, Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-05) | March 28, 2025 |
| 61442-227-10 | 61442-227 | Carlsbad Technology, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-10) | March 28, 2025 |
| 61442-227-60 | 61442-227 | Carlsbad Technology, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (61442-227-60) | March 28, 2025 |
| 67046-1482-3 | 67046-1482 | Coupler LLC | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (67046-1482-3) | January 29, 2025 |
| 51407-536-01 | 51407-536 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-536-01) | April 8, 2025 |
| 51407-537-01 | 51407-537 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-01) | April 8, 2025 |
| 51407-537-10 | 51407-537 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-10) | April 8, 2025 |
| 51407-537-18 | 51407-537 | Golden State Medical Supply, Inc. | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-537-18) | April 8, 2025 |
| 51407-538-01 | 51407-538 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-01) | April 8, 2025 |
| 51407-538-10 | 51407-538 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-10) | April 8, 2025 |
| 51407-538-18 | 51407-538 | Golden State Medical Supply, Inc. | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-538-18) | April 8, 2025 |
| 51407-967-01 | 51407-967 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-967-01) | December 4, 2025 |
| 51407-967-10 | 51407-967 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-967-10) | December 4, 2025 |
| 51407-967-18 | 51407-967 | Golden State Medical Supply, Inc. | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-967-18) | December 4, 2025 |
| 51407-968-01 | 51407-968 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-968-01) | December 4, 2025 |
| 51407-968-10 | 51407-968 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-968-10) | December 4, 2025 |
| 51407-968-18 | 51407-968 | Golden State Medical Supply, Inc. | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51407-968-18) | December 4, 2025 |
| 60429-421-01 | 60429-421 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-421-01) | July 27, 2015 |
| 60429-421-10 | 60429-421 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-421-10) | July 27, 2015 |
| 60429-422-01 | 60429-422 | Golden State Medical Supply, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-01) | July 27, 2015 |
| 60429-422-10 | 60429-422 | Golden State Medical Supply, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-10) | July 27, 2015 |
| 60429-422-18 | 60429-422 | Golden State Medical Supply, Inc. | 180 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-18) | July 27, 2015 |
| 60429-422-60 | 60429-422 | Golden State Medical Supply, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (60429-422-60) | July 27, 2015 |
| 72603-600-01 | 72603-600 | NorthStar Rx LLC | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-600-01) | April 23, 2025 |
| 72603-601-01 | 72603-601 | NorthStar Rx LLC | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-601-01) | April 23, 2025 |
| 72603-604-01 | 72603-604 | NorthStar Rx LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-01) | April 23, 2025 |
| 72603-604-02 | 72603-604 | NorthStar Rx LLC | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-02) | April 23, 2025 |
| 72603-604-03 | 72603-604 | NorthStar Rx LLC | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (72603-604-03) | April 23, 2025 |
| 51655-176-26 | 51655-176 | Northwind Health Company, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-176-26) | July 17, 2023 |
| 51655-176-52 | 51655-176 | Northwind Health Company, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-176-52) | July 14, 2022 |
| 51655-176-84 | 51655-176 | Northwind Health Company, LLC | 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-176-84) | September 29, 2020 |
| 51655-280-26 | 51655-280 | Northwind Health Company, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-280-26) | December 6, 2022 |
| 51655-280-52 | 51655-280 | Northwind Health Company, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (51655-280-52) | October 26, 2022 |
| 82868-101-30 | 82868-101 | Northwind Health Company, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-101-30) | August 19, 2026 |
| 82868-101-90 | 82868-101 | Northwind Health Company, LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-101-90) | February 12, 2026 |
| 82868-114-30 | 82868-114 | Northwind Health Company, LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (82868-114-30) | August 17, 2026 |
| 68071-3184-1 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-1) | March 21, 2017 |
| 68071-3184-2 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-2) | March 21, 2017 |
| 68071-3184-3 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-3) | March 21, 2017 |
| 68071-3184-5 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-5) | March 21, 2017 |
| 68071-3184-6 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-6) | March 21, 2017 |
| 68071-3184-9 | 68071-3184 | NuCare Pharmaceuticals, Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-3184-9) | March 21, 2017 |
| 68071-5319-1 | 68071-5319 | NuCare Pharmaceuticals, Inc. | 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-5319-1) | September 2, 2026 |
| 66267-071-14 | 66267-071 | NuCare Pharmaceuticals,Inc. | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-071-14) | January 16, 2018 |
| 66267-071-20 | 66267-071 | NuCare Pharmaceuticals,Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-071-20) | January 16, 2018 |
| 66267-071-60 | 66267-071 | NuCare Pharmaceuticals,Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (66267-071-60) | January 14, 2025 |
| 68071-4117-2 | 68071-4117 | NuCare Pharmaceuticals,Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4117-2) | October 11, 2017 |
| 68071-4117-3 | 68071-4117 | NuCare Pharmaceuticals,Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4117-3) | October 11, 2017 |
| 68071-4117-4 | 68071-4117 | NuCare Pharmaceuticals,Inc. | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4117-4) | October 11, 2017 |
| 68071-4117-6 | 68071-4117 | NuCare Pharmaceuticals,Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4117-6) | October 11, 2017 |
| 68071-4117-9 | 68071-4117 | NuCare Pharmaceuticals,Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4117-9) | October 11, 2017 |
| 68071-4231-1 | 68071-4231 | NuCare Pharmaceuticals,Inc. | 21 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-1) | January 12, 2018 |
| 68071-4231-3 | 68071-4231 | NuCare Pharmaceuticals,Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-3) | January 12, 2018 |
| 68071-4231-5 | 68071-4231 | NuCare Pharmaceuticals,Inc. | 45 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-5) | January 12, 2018 |
| 68071-4231-6 | 68071-4231 | NuCare Pharmaceuticals,Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-6) | January 12, 2018 |
| 68071-4231-9 | 68071-4231 | NuCare Pharmaceuticals,Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4231-9) | January 12, 2018 |
| 68071-4934-4 | 68071-4934 | NuCare Pharmaceuticals,Inc. | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (68071-4934-4) | June 21, 2019 |
| 43063-467-14 | 43063-467 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-14) | August 23, 2013 |
| 43063-467-15 | 43063-467 | PD-Rx Pharmaceuticals, Inc. | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-15) | August 23, 2013 |
| 43063-467-20 | 43063-467 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-20) | August 23, 2013 |
| 43063-467-30 | 43063-467 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-467-30) | August 23, 2013 |
| 55289-150-10 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-10) | March 31, 2011 |
| 55289-150-15 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-15) | March 31, 2011 |
| 55289-150-20 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-20) | March 31, 2011 |
| 55289-150-28 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-28) | March 31, 2011 |
| 55289-150-30 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-30) | March 31, 2011 |
| 55289-150-60 | 55289-150 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (55289-150-60) | March 31, 2011 |
| 72789-578-20 | 72789-578 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-20) | August 12, 2026 |
| 72789-578-30 | 72789-578 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72789-578-30) | June 29, 2026 |
| 85509-1103-3 | 85509-1103 | PHOENIX RX LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-3) | November 14, 2025 |
| 85509-1103-6 | 85509-1103 | PHOENIX RX LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-6) | November 14, 2025 |
| 85509-1103-9 | 85509-1103 | PHOENIX RX LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1103-9) | November 14, 2025 |
| 85509-1201-3 | 85509-1201 | PHOENIX RX LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-3) | January 7, 2026 |
| 85509-1201-6 | 85509-1201 | PHOENIX RX LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85509-1201-6) | January 7, 2026 |
| 85509-1201-9 | 85509-1201 | PHOENIX RX LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85509-1201-9) | January 7, 2026 |
| 68788-8193-1 | 68788-8193 | Preferred Pharmaceuticals Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-1) | May 16, 2022 |
| 68788-8193-3 | 68788-8193 | Preferred Pharmaceuticals Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-3) | May 16, 2022 |
| 68788-8193-6 | 68788-8193 | Preferred Pharmaceuticals Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-6) | May 16, 2022 |
| 68788-8193-8 | 68788-8193 | Preferred Pharmaceuticals Inc. | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-8) | May 16, 2022 |
| 68788-8193-9 | 68788-8193 | Preferred Pharmaceuticals Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8193-9) | May 16, 2022 |
| 68788-8784-1 | 68788-8784 | Preferred Pharmaceuticals Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-1) | December 12, 2024 |
| 68788-8784-3 | 68788-8784 | Preferred Pharmaceuticals Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-3) | December 12, 2024 |
| 68788-8784-6 | 68788-8784 | Preferred Pharmaceuticals Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-6) | December 12, 2024 |
| 68788-8784-8 | 68788-8784 | Preferred Pharmaceuticals Inc. | 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-8) | December 12, 2024 |
| 68788-8784-9 | 68788-8784 | Preferred Pharmaceuticals Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (68788-8784-9) | December 12, 2024 |
| 68788-8952-1 | 68788-8952 | Preferred Pharmaceuticals Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-1) | November 20, 2015 |
| 68788-8952-3 | 68788-8952 | Preferred Pharmaceuticals Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-3) | November 20, 2015 |
| 68788-8952-6 | 68788-8952 | Preferred Pharmaceuticals Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-6) | November 20, 2015 |
| 68788-8952-8 | 68788-8952 | Preferred Pharmaceuticals Inc. | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-8) | November 20, 2015 |
| 68788-8952-9 | 68788-8952 | Preferred Pharmaceuticals Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-8952-9) | November 20, 2015 |
| 68788-9806-1 | 68788-9806 | Preferred Pharmaceuticals Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-1) | August 31, 2015 |
| 68788-9806-2 | 68788-9806 | Preferred Pharmaceuticals Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-2) | August 31, 2015 |
| 68788-9806-3 | 68788-9806 | Preferred Pharmaceuticals Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-3) | August 31, 2015 |
| 68788-9806-6 | 68788-9806 | Preferred Pharmaceuticals Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-6) | August 31, 2015 |
| 68788-9806-8 | 68788-9806 | Preferred Pharmaceuticals Inc. | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-8) | August 31, 2015 |
| 68788-9806-9 | 68788-9806 | Preferred Pharmaceuticals Inc. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68788-9806-9) | August 31, 2015 |
| 63187-012-06 | 63187-012 | Proficient Rx LP | 6 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-06) | May 13, 2026 |
| 63187-012-15 | 63187-012 | Proficient Rx LP | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-15) | November 22, 2019 |
| 63187-012-20 | 63187-012 | Proficient Rx LP | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-20) | November 1, 2016 |
| 63187-012-30 | 63187-012 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-30) | April 1, 2014 |
| 63187-012-60 | 63187-012 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-012-60) | October 1, 2014 |
| 63187-222-15 | 63187-222 | Proficient Rx LP | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-15) | September 1, 2014 |
| 63187-222-30 | 63187-222 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-30) | September 1, 2014 |
| 63187-222-60 | 63187-222 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-60) | September 1, 2014 |
| 63187-222-90 | 63187-222 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (63187-222-90) | September 1, 2014 |
| 63187-522-30 | 63187-522 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-30) | February 1, 2015 |
| 63187-522-60 | 63187-522 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-60) | February 1, 2015 |
| 63187-522-90 | 63187-522 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-522-90) | February 1, 2015 |
| 63187-714-15 | 63187-714 | Proficient Rx LP | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-714-15) | June 1, 2016 |
| 63187-714-30 | 63187-714 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-714-30) | June 1, 2016 |
| 63187-714-60 | 63187-714 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-714-60) | June 1, 2016 |
| 63187-714-90 | 63187-714 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-714-90) | June 1, 2016 |
| 63187-761-15 | 63187-761 | Proficient Rx LP | 15 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-15) | January 2, 2017 |
| 63187-761-30 | 63187-761 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-30) | October 3, 2016 |
| 63187-761-60 | 63187-761 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-60) | October 3, 2016 |
| 63187-761-90 | 63187-761 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (63187-761-90) | October 3, 2016 |
| 71205-494-30 | 71205-494 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-494-30) | October 20, 2020 |
| 71205-494-60 | 71205-494 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-494-60) | October 20, 2020 |
| 71205-494-90 | 71205-494 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-494-90) | October 20, 2020 |
| 71205-991-00 | 71205-991 | Proficient Rx LP | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-00) | April 1, 2020 |
| 71205-991-11 | 71205-991 | Proficient Rx LP | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-11) | April 1, 2020 |
| 71205-991-30 | 71205-991 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-30) | April 1, 2020 |
| 71205-991-55 | 71205-991 | Proficient Rx LP | 500 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-55) | April 1, 2020 |
| 71205-991-60 | 71205-991 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-60) | April 1, 2020 |
| 71205-991-72 | 71205-991 | Proficient Rx LP | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-72) | April 1, 2020 |
| 71205-991-78 | 71205-991 | Proficient Rx LP | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-78) | April 1, 2020 |
| 71205-991-90 | 71205-991 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-991-90) | April 1, 2020 |
| 71205-995-00 | 71205-995 | Proficient Rx LP | 100 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-00) | April 1, 2020 |
| 71205-995-11 | 71205-995 | Proficient Rx LP | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-11) | April 1, 2020 |
| 71205-995-30 | 71205-995 | Proficient Rx LP | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-30) | April 1, 2020 |
| 71205-995-60 | 71205-995 | Proficient Rx LP | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-60) | April 1, 2020 |
| 71205-995-72 | 71205-995 | Proficient Rx LP | 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-72) | April 1, 2020 |
| 71205-995-78 | 71205-995 | Proficient Rx LP | 180 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-78) | April 1, 2020 |
| 71205-995-90 | 71205-995 | Proficient Rx LP | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (71205-995-90) | April 1, 2020 |
| 70518-0627-1 | 70518-0627 | REMEDYREPACK INC. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-1) | October 23, 2017 |
| 70518-0627-2 | 70518-0627 | REMEDYREPACK INC. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0627-2) | November 11, 2019 |
| 70518-0756-0 | 70518-0756 | REMEDYREPACK INC. | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-0756-0) | October 4, 2017 |
| 70518-1104-2 | 70518-1104 | REMEDYREPACK INC. | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-1104-2) | April 16, 2024 |
| 70518-2707-3 | 70518-2707 | REMEDYREPACK INC. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-2707-3) | August 11, 2025 |
| 70518-4602-0 | 70518-4602 | REMEDYREPACK INC. | 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70518-4602-0) | April 21, 2026 |
| 70518-4694-0 | 70518-4694 | REMEDYREPACK INC. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70518-4694-0) | July 8, 2026 |
| 67296-1197-2 | 67296-1197 | RedPharm Drug, Inc. | 20 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-1197-2) | November 13, 1998 |
| 67296-1197-3 | 67296-1197 | RedPharm Drug, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-1197-3) | November 13, 1998 |
| 67296-1197-6 | 67296-1197 | RedPharm Drug, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-1197-6) | November 13, 1998 |
| 67296-2151-8 | 67296-2151 | Redpharm Drug | 28 TABLET, DELAYED RELEASE in 1 BOTTLE (67296-2151-8) | August 1, 2023 |
| 67296-2215-1 | 67296-2215 | Redpharm Drug | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67296-2215-1) | March 28, 2025 |
| 67296-2215-2 | 67296-2215 | Redpharm Drug | 28 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (67296-2215-2) | March 28, 2025 |
| 16571-201-06 | 16571-201 | Rising Pharma Holdings, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (16571-201-06) | August 19, 2008 |
| 16571-201-10 | 16571-201 | Rising Pharma Holdings, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-10) | August 19, 2008 |
| 16571-201-11 | 16571-201 | Rising Pharma Holdings, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-11) | August 19, 2008 |
| 16571-201-50 | 16571-201 | Rising Pharma Holdings, Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-201-50) | August 19, 2008 |
| 16571-202-06 | 16571-202 | Rising Pharma Holdings, Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-06) | December 31, 2010 |
| 16571-202-10 | 16571-202 | Rising Pharma Holdings, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-10) | December 31, 2010 |
| 16571-202-11 | 16571-202 | Rising Pharma Holdings, Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-202-11) | December 31, 2010 |
| 16571-203-03 | 16571-203 | Rising Pharma Holdings, Inc. | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-203-03) | July 22, 2024 |
| 16571-203-10 | 16571-203 | Rising Pharma Holdings, Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (16571-203-10) | December 31, 2010 |
| 70512-784-60 | 70512-784 | SOLA Pharmaceuticals, LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (70512-784-60) | November 14, 2025 |
| 85766-010-01 | 85766-010 | Sportpharm LLC | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-01) | June 18, 2025 |
| 85766-010-06 | 85766-010 | Sportpharm LLC | 6 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-06) | August 17, 2026 |
| 85766-010-14 | 85766-010 | Sportpharm LLC | 14 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-14) | September 24, 2025 |
| 85766-010-30 | 85766-010 | Sportpharm LLC | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-30) | June 18, 2025 |
| 85766-010-60 | 85766-010 | Sportpharm LLC | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (85766-010-60) | June 18, 2025 |
| 85766-010-90 | 85766-010 | Sportpharm LLC | 90 TABLET, DELAYED RELEASE in 1 BOTTLE (85766-010-90) | June 18, 2025 |
| 60760-090-15 | 60760-090 | St. Mary's Medical Park Pharmacy | 15 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-15) | July 5, 2022 |
| 60760-090-20 | 60760-090 | St. Mary's Medical Park Pharmacy | 20 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-20) | June 3, 2022 |
| 60760-090-30 | 60760-090 | St. Mary's Medical Park Pharmacy | 30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-30) | May 13, 2025 |
| 60760-090-60 | 60760-090 | St. Mary's Medical Park Pharmacy | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-60) | July 7, 2022 |
| 60760-090-90 | 60760-090 | St. Mary's Medical Park Pharmacy | 90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (60760-090-90) | June 25, 2025 |
| 60290-082-01 | 60290-082 | Umedica Laboratories USA Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-082-01) | February 15, 2026 |
| 60290-083-01 | 60290-083 | Umedica Laboratories USA Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-01) | February 15, 2026 |
| 60290-083-02 | 60290-083 | Umedica Laboratories USA Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-02) | February 15, 2026 |
| 60290-083-03 | 60290-083 | Umedica Laboratories USA Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-03) | February 15, 2026 |
| 60290-083-04 | 60290-083 | Umedica Laboratories USA Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-083-04) | February 15, 2026 |
| 60290-084-01 | 60290-084 | Umedica Laboratories USA Inc. | 60 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-01) | February 15, 2026 |
| 60290-084-02 | 60290-084 | Umedica Laboratories USA Inc. | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-02) | February 15, 2026 |
| 60290-084-03 | 60290-084 | Umedica Laboratories USA Inc. | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-03) | February 15, 2026 |
| 60290-084-04 | 60290-084 | Umedica Laboratories USA Inc. | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (60290-084-04) | February 15, 2026 |
| 50090-0538 | 50090-0538 | A-S Medication Solutions | — | March 26, 1996 |
| 50090-0539 | 50090-0539 | A-S Medication Solutions | — | March 26, 1996 |
| 50090-0540 | 50090-0540 | A-S Medication Solutions | — | December 31, 2010 |
| 50090-0541 | 50090-0541 | A-S Medication Solutions | — | December 31, 2010 |
| 50090-0542 | 50090-0542 | A-S Medication Solutions | — | November 13, 1998 |
| 50090-0545 | 50090-0545 | A-S Medication Solutions | — | November 13, 1998 |
| 50090-6924 | 50090-6924 | A-S Medication Solutions | — | August 19, 2008 |
| 50090-7646 | 50090-7646 | A-S Medication Solutions | — | April 23, 2025 |
| 50090-7647 | 50090-7647 | A-S Medication Solutions | — | April 23, 2025 |
| 50090-7818 | 50090-7818 | A-S Medication Solutions | — | November 13, 1998 |
| 50090-7838 | 50090-7838 | A-S Medication Solutions | — | March 28, 2025 |
| 50090-7839 | 50090-7839 | A-S Medication Solutions | — | March 28, 2025 |
| 50090-7855 | 50090-7855 | A-S Medication Solutions | — | April 17, 2025 |
| 50090-7856 | 50090-7856 | A-S Medication Solutions | — | April 17, 2025 |
| 50090-7880 | 50090-7880 | A-S Medication Solutions | — | March 28, 2025 |
| 50090-7881 | 50090-7881 | A-S Medication Solutions | — | March 28, 2025 |
| 0228-2550 | 0228-2550 | Actavis Pharma, Inc. | — | March 26, 1996 |
| 0228-2551 | 0228-2551 | Actavis Pharma, Inc. | — | March 26, 1996 |
| 72888-109 | 72888-109 | Advagen Pharma Ltd | — | May 11, 2023 |
| 72888-110 | 72888-110 | Advagen Pharma Ltd | — | May 11, 2023 |
| 72888-111 | 72888-111 | Advagen Pharma Ltd | — | May 11, 2023 |
| 80425-0055 | 80425-0055 | Advanced Rx Pharmacy of Tennessee, LLC | — | November 13, 1998 |
| 80425-0189 | 80425-0189 | Advanced Rx Pharmacy of Tennessee, LLC | — | November 13, 1998 |
| 80425-0197 | 80425-0197 | Advanced Rx Pharmacy of Tennessee, LLC | — | October 27, 2022 |
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 |
| Drug Shortages | FDA | Supply availability |
Generated September 25, 2026 · 13 sections on this page.