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Etodolac
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 |
|---|---|---|---|---|---|---|---|
| 075126-001 | ETODOLAC | CAPSULE | ETODOLAC | Prescription | AB | ||
| 075126-002 | ETODOLAC | CAPSULE | ETODOLAC | 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 | 12 | Labeling | Approved | April 28, 2021 | Standard |
| Supplement | 9 | Labeling | Approved | May 9, 2016 | Standard |
| Supplement | 5 | Labeling | Approved | February 7, 2013 | — |
| Supplement | 3 | Labeling | Approved | January 11, 2007 | — |
| Supplement | 2 | Labeling | Approved | March 2, 2006 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | May 8, 2002 | — |
| Original application | 1 | Approved | September 16, 1999 | — |
Review documents
- 0 · Original application · September 16, 1999
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260828). 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 1 ) 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 ). • Etodolac capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS ). 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 (GI) events. (See WARNINGS ). 1 Throughout this package insert, the term NSAID refers to a non-aspirin nonsteroidal anti-inflammatory drug.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Etodolac Capsules and Tablets are indicated: For acute and long-term use in the management of signs and symptoms of the following: Osteoarthritis Rheumatoid arthritis For the management of acute pain
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of etodolac capsules and tablets and other treatment options before deciding to use etodolac capsules and 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 etodolac capsules and tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Dosage adjustment of etodolac capsules and tablets is generally not required in patients with mild to moderate renal impairment. Etodolac should be used with caution in such patients, because, as with other NSAIDs, it may further decrease renal function in some patients with impaired renal function (see WARNINGS, Renal Effects ). Analgesia The recommended total daily dose of etodolac for acute pain is up to 1000 mg, given as 200-400 mg every 6 to 8 hours. Doses of etodolac greater than 1000 mg/day have not been adequately evaluated in well-controlled trials. Osteoarthritis and Rheumatoid Arthritis The recommended starting dose of etodolac for the management of the signs and symptoms of osteoarthritis or rheumatoid arthritis is: 300 mg b.i.d., t.i.d., or 400 mg b.i.d., or 500 mg b.i.d. A lower dose of 600 mg/day may suffice for long-term administration. Physicians should be aware that doses above 1000 mg/day have not been adequately evaluated in well-controlled clinical trials. In chronic conditions, a therapeutic response to therapy with etodolac is sometimes seen within one week of therapy, 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.
Dosage Forms and Strengths
openFDA Drug LabelingCLINICAL TRIALS Analgesia Controlled clinical trials in analgesia were single-dose, randomized, double-blind, parallel studies in three pain models, including dental extractions. The analgesic effective dose for etodolac established in these acute pain models was 200 to 400 mg. The onset of analgesia occurred approximately 30 minutes after oral administration. Etodolac 200 mg provided efficacy comparable to that obtained with aspirin (650 mg). Etodolac 400 mg provided efficacy comparable to that obtained with acetaminophen with codeine (600 mg + 60 mg). The peak analgesic effect was between 1 to 2 hours. Duration of relief averaged 4 to 5 hours for 200 mg of etodolac and 5 to 6 hours for 400 mg of etodolac as measured by when approximately half of the patients required remedication. Osteoarthritis The use of etodolac in managing the signs and symptoms of osteoarthritis of the hip or knee was assessed in double-blind, randomized, controlled clinical trials in 341 patients. In patients with osteoarthritis of the knee, etodolac, in doses of 600 to 1000 mg/day, was better than placebo in two studies. The clinical trials in osteoarthritis used b.i.d. dosage regimens. Rheumatoid Arthritis In a 3-month study with 426 patients, etodolac 300 mg b.i.d. was effective in management of rheumatoid arthritis and comparable in efficacy to piroxicam 20 mg/day. In a long-term study with 1,446 patients in which 60% of patients completed 6 months of therapy and 20% completed 3 years of therapy, etodolac in a dose of 500 mg b.i.d. provided efficacy comparable to that obtained with ibuprofen 600 mg q.i.d. In clinical trials of rheumatoid arthritis patients, etodolac has been used in combination with gold, d-penicillamine, chloroquine, corticosteroids, and methotrexate.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Etodolac capsules are contraindicated in patients with known hypersensitivity to etodolac or other ingredients in etodolac capsules. Etodolac capsules should not be given to patients who have experienced asthma, urticaria, or other 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 ). Etodolac capsules are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ).
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 etodolac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS, Gastrointestinal Effects - Risk of Ulceration, Bleeding, 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 CONTRAINDICTIONS ). 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 etodolac capsules in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac capsules are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs, including etodolac capsules, 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 etodolac capsules, 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 …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS In patients taking etodolac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting. Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus. Adverse-reaction information for etodolac was derived from 2,629 arthritic patients treated with etodolac capsules in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with etodolac. New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of etodolac b.i.d. (i.e., 600 to 1000 mg/day). Incidence Greater Than or Equal to 1% - Probably Causally Related Body as a whole - Chills and fever. Digestive system - Dyspepsia (10%), abdominal pain * , diarrhea * , flatulence * , nausea * , abdominal distension, epigastric pain, abnormal stools, constipation, gastritis, melena, vomiting. Nervous system - Asthenia/malaise * , dizziness * , depression, nervousness, fatigue. Skin and appendages - Pruritus, rash. Special senses - Blurred vision, tinnitus. Urogenital system - Dysuria, urinary frequency. Musculoskeletal - Arthralgia. * Drug-related patient complaints occurring in 3 to 9% of patients treated with etodolac. Drug-related patient complaints occurring in fewer than 3%, but more than 1%, are unmarked. Incidence Less Than 1% - Probably Causally Related (Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.) Body as a whole - Allergic reaction, anaphylactic/anaphylactoid reactions (including shock) . Cardiovascular system - Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic) . Digestive system - Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis , hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis . Hemic and lymphatic system - Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, aplastic anemia, leukopenia, neutropenia, pancytopenia. Metabolic and nutritional - Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients. Nervous system - Insomnia, somnolence. Respiratory system - Asthma, pulmonary infiltration with eosinophilia . Skin and appendages - Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, fixed drug eruption (FDE), leukocytoclastic vasculitis, hyperpigmentation, erythema multiforme . Special senses - Photophobia, transient visual disturbances. Urogenital system - Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis . Incidence Less Than 1% - Causal Relationship Unknown (Medical events occurring under circumstances where causal relationship to etodolac is uncertain. These reactions are listed as alerting information for physicians.) Body as a whole - Infection, headache. Cardiovascular system - Arrhythmias, myocardial infarction, cerebrovascular accident. Digestive system - Esophagitis with or without stricture or cardiospasm, colitis, GI discom …
Drug Interactions
openFDA Drug LabelingDrug Interactions 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 (see WARNINGS ). Antacids The concomitant administration of antacids has no apparent effect on the extent of absorption of etodolac. However, antacids can decrease the peak concentration reached by 15% to 20% but have no detectable effect on the time-to-peak. Aspirin When etodolac is administered with aspirin, its protein binding is reduced, although the clearance of free etodolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of etodolac and aspirin is not generally recommended because of the potential of increased adverse effects. Cyclosporine, Digoxin, Methotrexate Etodolac, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs leading to elevated serum levels of cyclosporine, digoxin, methotrexate, and increased toxicity. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given etodolac, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. NSAIDs, such as etodolac, should not be administered prior to or concomitantly with high doses of 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. In general, caution should be used when NSAIDs are administered concomitantly with methotrexate. Diuretics Etodolac has no apparent pharmacokinetic interaction when administered with furosemide or hydrochlorothiazide. Nevertheless, clinical studies, as well as postmarketing observations have shown that etodolac can reduce the natriuretic effect of furosemide and thiazides in some patients with possible loss of blood pressure control. 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 insufficiency or failure (see WARNINGS, Renal Effects ), as well as to assure diuretic efficacy. Glyburide Etodolac has no apparent pharmacokinetic interaction when administered with glyburide. Lithium NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity. Careful monitoring of lithium levels is advised in the event NSAID dosage adjustments are required. Phenylbutazone Phenylbutazone causes increase (by about 80%) in the free fraction of etodolac. Although in vivo studies have not been done to see if etodolac clearance is changed by coadministration of phenylbutazone, it is not recommended that they be coadministered. Phenytoin Etodolac has no apparent pharmacokinetic interaction when administered with phenytoin. Warfarin The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than that of users of either drug alone. Short-term pharmacokinetic studies have demonstrated that concomitant administration of warfarin and etodolac results in reduced protein binding of warfarin, but there was no change in the clearance of free warfarin. There was no significant difference in the pharmacodynamic effect of warfarin administered alone and warfarin administered with etodolac as measured by prothrombin time. Thus, co …
Description
openFDA Drug LabelingDESCRIPTION Etodolac capsules and tablets, USP are members of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet and capsule contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. Etodolac is a white crystalline compound, insoluble in water but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight of the base is 287.37. It has a pKa of 4.65 and an n-octanol: water partition coefficient of 11.4 at pH 7.4. The molecular formula for etodolac is C 17 H 21 NO 3 , and it has the following structural formula: Each Capsule, for oral administration, contains 200 or 300 mg of Etodolac. In addition, each capsule contains the following inactive ingredients: Ammonium Hydroxide USP, Black Iron Oxide USP, Colloidal Silicone Dioxide NF, Erythrosine (200 mg only), Ethyl Alcohol USP, Gelatin, Isopropyl Alcohol USP, Lactose Monohydrate NF, Magnesium Stearate NF, Microcrystalline Cellulose NF, N-Butyl Alcohol USP, Povidone USP, Propylene Glycol USP, Purified Water USP, Shellac, Titanium Dioxide. Each Tablet, for oral administration, contains 400 mg or 500 mg of Etodolac. In addition, each tablet contains the following inactive ingredients: Hydroxypropyl Methylcellulose USP, Lactose Monohydrate NF, Magnesium Stearate, Microcrystalline Cellulose NF, Polyethylene Glycol, Povidone USP, Sodium Starch Glycolate NF and Titanium Dioxide. Also, each 400 mg tablet contains Iron Oxide Red and Iron Oxide Yellow. Each 500 mg tablet contains D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Red #40 Aluminum Lake. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur, and coma has occurred following massive ibuprofen or mefenamic-acid overdose. Hypertension/hypotension, acute renal failure, and respiratory depression may occur but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following overdose. Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of the urine, hemodialysis, or hemoperfusion would probably not be useful due to etodolac’s high protein binding.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Etodolac Capsules USP are available as: Etodolac Capsules USP Etodolac Capsules USP 200 mg are pink/pink E.H.G capsules of size '1' imprinted with "P" on cap and "2" on body in black ink filled with off-white to cream blend, and are available as follows: NDC 83980-031-13 Bottles of 30's NDC 83980-031-01 Bottles of 100's NDC 83980-031-05 Bottles of 500's Etodolac Capsules USP 300 mg are light pink/ light pink E.H.G capsules of size '0' imprinted with "P" on cap and "1" on body in black ink filled with off-white to cream blend, and are available as follows: NDC 83980-032-13 Bottles of 30's NDC 83980-032-01 Bottles of 100's NDC 83980-032-05 Bottles of 500's Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. protected from moisture. You may report side effects to FDA at 1-800-FDA-1088. Additional medication guides can be obtained by calling Ipca at 1-888-472-2651. Distributed by: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816, USA IERDN1 December 2024 Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal 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: o with increasing doses of NSAIDs o 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 : o anytime during use o without warning symptoms o that may cause death The risk of getting an ulcer or bleeding increases with: o past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs o taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" o increasing doses of NSAIDs o older age o longer use of NSAIDs o poor health o smoking o advanced liver disease o drinking alcohol o bleeding problems NSAIDs should only be used: o exactly as prescribed o at the lowest dose possible for your treatment o 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 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 of 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 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 medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "What is the most important information I should know about medicines called Nonsteroidal Anti-inflammato …
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ETODOLAC. 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.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-2132-1 | 50090-2132 | A-S Medication Solutions | 21 CAPSULE in 1 BOTTLE (50090-2132-1) | October 15, 2015 |
| 50090-8037-1 | 50090-8037 | A-S Medication Solutions | 21 CAPSULE in 1 BOTTLE (50090-8037-1) | August 25, 2026 |
| 62559-250-01 | 62559-250 | ANI Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE (62559-250-01) | March 9, 2015 |
| 62559-251-01 | 62559-251 | ANI Pharmaceuticals, Inc. | 100 CAPSULE in 1 BOTTLE (62559-251-01) | February 1, 2015 |
| 60505-0039-1 | 60505-0039 | Apotex Corp. | 100 CAPSULE in 1 BOTTLE (60505-0039-1) | May 1, 2003 |
| 60505-0040-1 | 60505-0040 | Apotex Corp. | 100 CAPSULE in 1 BOTTLE (60505-0040-1) | May 1, 2003 |
| 63629-1935-1 | 63629-1935 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (63629-1935-1) | June 29, 2021 |
| 63629-1936-1 | 63629-1936 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (63629-1936-1) | June 29, 2021 |
| 63629-3641-1 | 63629-3641 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (63629-3641-1) | May 15, 2017 |
| 63629-3641-2 | 63629-3641 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (63629-3641-2) | December 22, 2021 |
| 63629-3641-3 | 63629-3641 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (63629-3641-3) | December 22, 2021 |
| 71335-3119-1 | 71335-3119 | Bryant Ranch Prepack | 60 CAPSULE in 1 BOTTLE (71335-3119-1) | August 25, 2026 |
| 71335-3119-2 | 71335-3119 | Bryant Ranch Prepack | 90 CAPSULE in 1 BOTTLE (71335-3119-2) | March 23, 2026 |
| 71335-3119-3 | 71335-3119 | Bryant Ranch Prepack | 18 CAPSULE in 1 BOTTLE (71335-3119-3) | August 25, 2026 |
| 72162-1756-1 | 72162-1756 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (72162-1756-1) | March 25, 2026 |
| 72162-1757-1 | 72162-1757 | Bryant Ranch Prepack | 100 CAPSULE in 1 BOTTLE (72162-1757-1) | March 25, 2026 |
| 60429-243-01 | 60429-243 | Golden State Medical Supply, Inc. | 100 CAPSULE in 1 BOTTLE (60429-243-01) | July 18, 2011 |
| 60429-244-01 | 60429-244 | Golden State Medical Supply, Inc. | 100 CAPSULE in 1 BOTTLE (60429-244-01) | July 18, 2011 |
| 83980-031-01 | 83980-031 | Ipca Laboratories Limited | 100 CAPSULE in 1 BOTTLE (83980-031-01) | February 6, 2026 |
| 83980-031-05 | 83980-031 | Ipca Laboratories Limited | 500 CAPSULE in 1 BOTTLE (83980-031-05) | February 6, 2026 |
| 83980-031-13 | 83980-031 | Ipca Laboratories Limited | 30 CAPSULE in 1 BOTTLE (83980-031-13) | February 6, 2026 |
| 83980-032-01 | 83980-032 | Ipca Laboratories Limited | 100 CAPSULE in 1 BOTTLE (83980-032-01) | February 6, 2026 |
| 83980-032-05 | 83980-032 | Ipca Laboratories Limited | 500 CAPSULE in 1 BOTTLE (83980-032-05) | February 6, 2026 |
| 83980-032-13 | 83980-032 | Ipca Laboratories Limited | 30 CAPSULE in 1 BOTTLE (83980-032-13) | February 6, 2026 |
| 51655-166-52 | 51655-166 | Northwind Health Company, LLC | 30 CAPSULE in 1 BOTTLE, DISPENSING (51655-166-52) | November 13, 2014 |
| 71205-743-20 | 71205-743 | Proficient Rx LP | 20 CAPSULE in 1 BOTTLE (71205-743-20) | January 16, 2023 |
| 71205-743-30 | 71205-743 | Proficient Rx LP | 30 CAPSULE in 1 BOTTLE (71205-743-30) | January 16, 2023 |
| 71205-743-60 | 71205-743 | Proficient Rx LP | 60 CAPSULE in 1 BOTTLE (71205-743-60) | January 16, 2023 |
| 71205-743-90 | 71205-743 | Proficient Rx LP | 90 CAPSULE in 1 BOTTLE (71205-743-90) | January 16, 2023 |
| 51672-4016-1 | 51672-4016 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4016-1) | April 30, 1998 |
| 51672-4017-1 | 51672-4017 | Sun Pharmaceutical Industries, Inc. | 100 CAPSULE in 1 BOTTLE (51672-4017-1) | April 30, 1998 |
| 50090-2132 | 50090-2132 | A-S Medication Solutions | — | February 1, 2015 |
| 50090-8037 | 50090-8037 | A-S Medication Solutions | — | February 6, 2026 |
| 62559-250 | 62559-250 | ANI Pharmaceuticals, Inc. | — | March 9, 2015 |
| 62559-251 | 62559-251 | ANI Pharmaceuticals, Inc. | — | February 1, 2015 |
| 60505-0039 | 60505-0039 | Apotex Corp. | — | May 1, 2003 |
| 60505-0040 | 60505-0040 | Apotex Corp. | — | May 1, 2003 |
| 63629-1935 | 63629-1935 | Bryant Ranch Prepack | — | March 9, 2015 |
| 63629-1936 | 63629-1936 | Bryant Ranch Prepack | — | February 1, 2015 |
| 63629-3641 | 63629-3641 | Bryant Ranch Prepack | — | March 9, 2015 |
| 71335-3119 | 71335-3119 | Bryant Ranch Prepack | — | April 30, 1998 |
| 72162-1756 | 72162-1756 | Bryant Ranch Prepack | — | March 9, 2015 |
| 72162-1757 | 72162-1757 | Bryant Ranch Prepack | — | February 1, 2015 |
| 60429-243 | 60429-243 | Golden State Medical Supply, Inc. | — | April 30, 1998 |
| 60429-244 | 60429-244 | Golden State Medical Supply, Inc. | — | April 30, 1998 |
| 83980-031 | 83980-031 | Ipca Laboratories Limited | — | February 6, 2026 |
| 83980-032 | 83980-032 | Ipca Laboratories Limited | — | February 6, 2026 |
| 51655-166 | 51655-166 | Northwind Health Company, LLC | — | November 13, 2014 |
| 71205-743 | 71205-743 | Proficient Rx LP | — | March 9, 2015 |
| 51672-4016 | 51672-4016 | Sun Pharmaceutical Industries, Inc. | — | April 30, 1998 |
| 51672-4017 | 51672-4017 | Sun Pharmaceutical Industries, Inc. | — | April 30, 1998 |
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 |
Generated September 25, 2026 · 12 sections on this page.