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Nabumetone
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 |
|---|---|---|---|---|---|---|---|
| 078420-001 | NABUMETONE | TABLET | NABUMETONE | Prescription | AB | ||
| 078420-002 | NABUMETONE | TABLET | NABUMETONE | 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 | 15 | Labeling | Approved | November 21, 2024 | Standard |
| Supplement | 6 | Labeling | Approved | April 28, 2021 | Standard |
| Supplement | 1 | Labeling | Approved | May 9, 2016 | Standard |
| Original application | 1 | Approved | September 24, 2008 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260819). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBoxed Warning 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 and PRECAUTIONS]. Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS]. Gastrointestinal Risk • NSAIDs 1 cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS). 1Throughout this package insert, the term NSAID refers to a non-aspirin non-steroidal anti-inflammatory drug.
Indications and Usage
openFDA Drug LabelingIndications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of nabumetone tablets, USP and other treatment options before deciding to use nabumetone tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Nabumetone tablets, USP are indicated for relief of signs and symptoms of osteoarthritis and rheumatoid arthritis.
Dosage and Administration
openFDA Drug LabelingDosage and Administration Section DOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of nabumetone tablets and other treatment options before deciding to use nabumetone 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 nabumetone tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. Osteoarthritis and Rheumatoid Arthritis: The recommended starting dose is 1,000 mg taken as a single dose with or without food. Some patients may obtain more symptomatic relief from 1,500 mg to 2,000 mg per day. Nabumetone tablets can be given in either a single or twice-daily dose. Dosages greater than 2,000 mg per day have not been studied. The lowest effective dose should be used for chronic treatment (see WARNINGS, RENAL EFFECTS). Patients weighing under 50 kg may be less likely to require dosages beyond 1,000 mg; therefore, after observing the response to initial therapy, the dose should be adjusted to meet individual patients’ requirements.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Nabumetone tablets are contraindicated in patients with known hypersensitivity to nabumetone or its excipients. Nabumetone tablets should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients (see WARNINGS , Error! Hyperlink reference not valid. , and PRECAUTIONS , Error! Hyperlink reference not valid., Error! Hyperlink reference not valid. ). Nabumetone tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see Warnings ].
Warnings and Cautions
openFDA Drug LabelingWarnings and Precautions CARDIOVASCULAR EFFECTS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as nabumetone, increases the risk of serious gastrointestinal (GI) events [see WARNINGS]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 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 nabumetone tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If nabumetone tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension: NSAIDs, including nabumetone tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including nabumetone, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally …
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 nabumetone, increases the risk of serious gastrointestinal (GI) events [see Warnings ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10–14 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 nabumetone tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If nabumetone tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension: NSAIDs, including nabumetone tablets, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking thiazides or loop diuretics may have impaired response to these therapies when taking NSAIDs. NSAIDs, including nabumetone, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retent …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Adverse reaction information was derived from blinded-controlled and open-labelled clinical trials and from worldwide marketing experience. In the description below, rates of the more common events (greater than 1%) and many of the less common events (less than 1%) represent results of US clinical studies. Of the 1,677 patients who received nabumetone during US clinical trials, 1,524 were treated for at least 1 month, 1,327 for at least 3 months, 929 for at least a year, and 750 for at least 2 years. More than 300 patients have been treated for 5 years or longer. The most frequently reported adverse reactions were related to the gastrointestinal tract and included diarrhea, dyspepsia, and abdominal pain. Incidence ≥ 1%—Probably Causally Related Gastrointestinal: Diarrhea (14%), dyspepsia (13%), abdominal pain (12%), constipation * , flatulence * , nausea * , positive stool guaiac * , dry mouth, gastritis, stomatitis, vomiting. Central Nervous System: Dizziness * , headache * , fatigue, increased sweating, insomnia, nervousness, somnolence. Dermatologic: Pruritus * , rash * . Special Senses: Tinnitus * . Miscellaneous: Edema * . * Incidence of reported reaction between 3% and 9%. Reactions occurring in 1% to 3% of the patients are unmarked. Incidence <1%—Probably Causally Related † Gastrointestinal: Anorexia, jaundice, duodenal ulcer, dysphagia, gastric ulcer, gastroenteritis, gastrointestinal bleeding, increased appetite, liver function abnormalities, melena, hepatic failure . Central Nervous System: Asthenia, agitation, anxiety, confusion, depression, malaise, paresthesia, tremor, vertigo. Dermatologic: Bullous eruptions, photosensitivity, urticaria, pseudoporphyria cutanea tarda, exfoliative dermatitis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, and fixed drug eruption (FDE). Cardiovascular: Vasculitis. Metabolic: Weight gain. Respiratory: Dyspnea, eosinophilic pneumonia, hypersensitivity pneumonitis, idiopathic interstitial pneumonitis . Genitourinary: Albuminuria, azotemia, hyperuricemia, interstitial nephritis, nephrotic syndrome, vaginal bleeding, renal failure . Special Senses: Abnormal vision. Hematologic/Lymphatic: Thrombocytopenia . Hypersensitivity: Anaphylactoid reaction, anaphylaxis , angioneurotic edema. † Adverse reactions reported only in worldwide postmarketing experience or in the literature, not seen in clinical trials, are considered rarer and are italicized. Incidence <1%—Causal Relationship Unknown Gastrointestinal: Bilirubinuria, duodenitis, eructation, gallstones, gingivitis, glossitis, pancreatitis, rectal bleeding. Central Nervous System: Nightmares. Dermatologic: Acne, alopecia. Cardiovascular: Angina, arrhythmia, hypertension, myocardial infarction, palpitations, syncope, thrombophlebitis. Respiratory: Asthma, cough. Genitourinary: Dysuria, hematuria, impotence, renal stones. Special Senses: Taste disorder. Body as a Whole: Fever, chills. Hematologic/Lymphatic: Anemia, leukopenia, granulocytopenia. Metabolic/Nutritional: Hyperglycemia, hypokalemia, weight loss.
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. Aspirin: When nabumetone tablets are administered with aspirin, its protein binding is reduced, although the clearance of free nabumetone is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of nabumetone tablets and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics: Clinical studies, as well as post marketing observations, have shown that nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure (see WARNINGS , Error! Hyperlink reference not valid. ), as well as to assure diuretic efficacy. 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. Methotrexate: NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate. Warfarin: 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 users of either drug alone. In vitro studies have shown that, because of its affinity for protein, 6MNA may displace other protein-bound drugs from their binding site. Caution should be exercised when administering nabumetone with warfarin since interactions have been seen with other NSAIDs. Concomitant administration of an aluminum-containing antacid had no significant effect on the bioavailability of 6MNA. When administered with food or milk, there is more rapid absorption; however, the total amount of 6MNA in the plasma is unchanged (see CLINICAL PHARMACOLOGY , Error! Hyperlink reference not valid. ).
Description
openFDA Drug LabelingDESCRIPTION Nabumetone is a naphthylalkanone designated chemically as 4-(6-methoxy-2- naphthalenyl)-2-butanone. It has the following structure: Nabumetone is a white or almost white crystalline substance with a molecular weight of 228.3. It is nonacidic, freely soluble in acetone, sparingly soluble in alcohol and in methanol, practically insoluble in water. It has an n-octanol:phosphate buffer partition coefficient of 2400 at pH 7.4. Tablets for Oral Administration Each white coloured, oval shaped, biconvex, film coated tablet contains 500 mg or 750 mg of nabumetone. Inactive ingredients consists of hypromellose, microcrystalline cellulose, sodium lauryl sulfate, sodium starch glycolate and opadry white OY 58900 [hypromellose, polyethylene glycol 400, and titanium dioxide]. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE Symptoms following acute NSAIDs overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 grams 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 urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. There have been overdoses of up to 25 grams of nabumetone reported with no long-term sequelae following standard emergency treatment (i.e., activated charcoal, gastric lavage, IV H 2 -blockers, etc.).
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Nabumetone Tablets, USP: Nabumetone tablets USP, 500 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘465’ on other side. Bottles of 6 NDC 85766-261-06 (repackaged from 50228-465-XX) Bottles of 7 NDC 85766-261-07 (repackaged from 50228-465-XX) Bottles of 10 NDC 85766-261-10 (repackaged from 50228-465-XX) Bottles of 20 NDC 85766-261-20 (repackaged from 50228-465-XX) Bottles of 30 NDC 85766-261-30 (relabeled from 50228-465-30) Bottles of 60 NDC 85766-261-60 (repackaged from 50228-465-XX) Bottles of 90 NDC 85766-261-90 (repackaged from 50228-465-XX) Bottles of 100 NDC 85766-261-01 (relabeled from 50228-465-01) Nabumetone tablets USP, 750 mg are white colored, oval shaped, biconvex, film coated tablets, debossed with ‘SG’ on one side ‘466’ on other side. Bottles of 6 NDC 85766-262-06 (repackaged from 50228-466-XX) Bottles of 7 NDC 85766-262-07 (repackaged from 50228-466-XX) Bottles of 10 NDC 85766-262-10 (repackaged from 50228-466-XX) Bottles of 20 NDC 85766-262-20 (repackaged from 50228-466-XX) Bottles of 30 NDC 85766-262-30 (relabeled from 50228-466-30) Bottles of 60 NDC 85766-262-60 (repackaged from 50228-466-XX) Bottles of 90 NDC 85766-262-90 (repackaged from 50228-466-XX) Bottles of 100 NDC 85766-262-01 (relabeled from 50228-466-01) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Rx Only Distributed by: Sportpharm LLC 379 Van Ness Ave 1401, Torrance, CA 90501 Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: NABUMETONE. 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 |
|---|---|---|---|---|
| 50090-5294-0 | 50090-5294 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5294-0) | October 23, 2020 |
| 50090-5294-7 | 50090-5294 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5294-7) | October 23, 2020 |
| 50090-5294-8 | 50090-5294 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5294-8) | October 23, 2020 |
| 50090-6167-0 | 50090-6167 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6167-0) | October 13, 2022 |
| 50090-6167-2 | 50090-6167 | A-S Medication Solutions | 14 TABLET in 1 BOTTLE (50090-6167-2) | October 13, 2022 |
| 50090-6167-3 | 50090-6167 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6167-3) | October 13, 2022 |
| 50090-6167-4 | 50090-6167 | A-S Medication Solutions | 20 TABLET in 1 BOTTLE (50090-6167-4) | October 13, 2022 |
| 87063-292-01 | 87063-292 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-292-01) | August 19, 2026 |
| 87063-292-06 | 87063-292 | ASCLEMED USA INC. | 6 TABLET in 1 BOTTLE (87063-292-06) | August 19, 2026 |
| 87063-292-07 | 87063-292 | ASCLEMED USA INC. | 7 TABLET in 1 BOTTLE (87063-292-07) | August 19, 2026 |
| 87063-292-10 | 87063-292 | ASCLEMED USA INC. | 10 TABLET in 1 BOTTLE (87063-292-10) | August 19, 2026 |
| 87063-292-20 | 87063-292 | ASCLEMED USA INC. | 20 TABLET in 1 BOTTLE (87063-292-20) | August 19, 2026 |
| 87063-292-30 | 87063-292 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-292-30) | August 19, 2026 |
| 87063-292-60 | 87063-292 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-292-60) | August 19, 2026 |
| 87063-292-90 | 87063-292 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-292-90) | August 19, 2026 |
| 80425-0104-1 | 80425-0104 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET in 1 BOTTLE (80425-0104-1) | June 26, 2019 |
| 80425-0104-2 | 80425-0104 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0104-2) | April 7, 2023 |
| 80425-0104-3 | 80425-0104 | Advanced Rx Pharmacy of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0104-3) | April 7, 2023 |
| 80425-0054-1 | 80425-0054 | Advanced Rx of Tennessee, LLC | 60 TABLET in 1 BOTTLE (80425-0054-1) | June 26, 2019 |
| 80425-0054-2 | 80425-0054 | Advanced Rx of Tennessee, LLC | 90 TABLET in 1 BOTTLE (80425-0054-2) | June 26, 2019 |
| 76420-210-07 | 76420-210 | Asclemed USA, Inc. | 7 TABLET in 1 BOTTLE (76420-210-07) | March 8, 2022 |
| 76420-210-10 | 76420-210 | Asclemed USA, Inc. | 10 TABLET in 1 BOTTLE (76420-210-10) | March 8, 2022 |
| 76420-210-14 | 76420-210 | Asclemed USA, Inc. | 14 TABLET in 1 BOTTLE (76420-210-14) | March 8, 2022 |
| 76420-210-20 | 76420-210 | Asclemed USA, Inc. | 20 TABLET in 1 BOTTLE (76420-210-20) | March 8, 2022 |
| 76420-210-30 | 76420-210 | Asclemed USA, Inc. | 30 TABLET in 1 BOTTLE (76420-210-30) | March 8, 2022 |
| 76420-210-60 | 76420-210 | Asclemed USA, Inc. | 60 TABLET in 1 BOTTLE (76420-210-60) | March 8, 2022 |
| 63629-8506-1 | 63629-8506 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-8506-1) | June 26, 2019 |
| 63629-8508-1 | 63629-8508 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8508-1) | June 26, 2019 |
| 63629-8509-1 | 63629-8509 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-8509-1) | June 26, 2019 |
| 63629-8510-1 | 63629-8510 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-8510-1) | June 26, 2019 |
| 71335-1391-1 | 71335-1391 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1391-1) | December 9, 2019 |
| 71335-1391-2 | 71335-1391 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1391-2) | December 20, 2019 |
| 71335-1391-3 | 71335-1391 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1391-3) | November 14, 2019 |
| 71335-1391-4 | 71335-1391 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1391-4) | November 7, 2019 |
| 71335-1391-5 | 71335-1391 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-1391-5) | December 28, 2021 |
| 71335-1391-6 | 71335-1391 | Bryant Ranch Prepack | 56 TABLET in 1 BOTTLE (71335-1391-6) | July 13, 2020 |
| 71335-1391-7 | 71335-1391 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1391-7) | December 28, 2021 |
| 71335-1391-8 | 71335-1391 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1391-8) | December 28, 2021 |
| 71335-1391-9 | 71335-1391 | Bryant Ranch Prepack | 9 TABLET in 1 BOTTLE (71335-1391-9) | December 28, 2021 |
| 71335-1559-0 | 71335-1559 | Bryant Ranch Prepack | 7 TABLET in 1 BOTTLE (71335-1559-0) | February 10, 2022 |
| 71335-1559-1 | 71335-1559 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1559-1) | February 10, 2022 |
| 71335-1559-2 | 71335-1559 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1559-2) | February 10, 2022 |
| 71335-1559-3 | 71335-1559 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1559-3) | February 10, 2022 |
| 71335-1559-4 | 71335-1559 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1559-4) | February 10, 2022 |
| 71335-1559-5 | 71335-1559 | Bryant Ranch Prepack | 42 TABLET in 1 BOTTLE (71335-1559-5) | February 10, 2022 |
| 71335-1559-6 | 71335-1559 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1559-6) | February 10, 2022 |
| 71335-1559-7 | 71335-1559 | Bryant Ranch Prepack | 14 TABLET in 1 BOTTLE (71335-1559-7) | February 10, 2022 |
| 71335-1559-8 | 71335-1559 | Bryant Ranch Prepack | 6 TABLET in 1 BOTTLE (71335-1559-8) | February 10, 2022 |
| 71335-1559-9 | 71335-1559 | Bryant Ranch Prepack | 9 TABLET in 1 BOTTLE (71335-1559-9) | February 10, 2022 |
| 71335-2292-1 | 71335-2292 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (71335-2292-1) | December 1, 2023 |
| 71335-2293-1 | 71335-2293 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (71335-2293-1) | December 1, 2023 |
| 72162-1557-1 | 72162-1557 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1557-1) | February 8, 2024 |
| 72162-1557-5 | 72162-1557 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1557-5) | February 8, 2024 |
| 72162-1558-1 | 72162-1558 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1558-1) | February 8, 2024 |
| 72162-1558-5 | 72162-1558 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1558-5) | February 8, 2024 |
| 51655-446-20 | 51655-446 | Northwind Health Company, LLC | 20 TABLET in 1 BOTTLE, PLASTIC (51655-446-20) | October 2, 2020 |
| 51655-446-25 | 51655-446 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (51655-446-25) | May 4, 2022 |
| 51655-446-52 | 51655-446 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-446-52) | December 23, 2020 |
| 51655-446-84 | 51655-446 | Northwind Health Company, LLC | 14 TABLET in 1 BOTTLE, PLASTIC (51655-446-84) | January 28, 2022 |
| 51655-733-52 | 51655-733 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-733-52) | July 7, 2021 |
| 72789-040-30 | 72789-040 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-040-30) | December 17, 2019 |
| 72789-540-14 | 72789-540 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (72789-540-14) | December 23, 2025 |
| 68788-7597-1 | 68788-7597 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7597-1) | February 13, 2020 |
| 68788-7597-2 | 68788-7597 | Preferred Pharmaceuticals Inc. | 20 TABLET in 1 BOTTLE (68788-7597-2) | February 13, 2020 |
| 68788-7597-3 | 68788-7597 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7597-3) | February 13, 2020 |
| 68788-7597-6 | 68788-7597 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7597-6) | February 13, 2020 |
| 68788-7597-8 | 68788-7597 | Preferred Pharmaceuticals Inc. | 120 TABLET in 1 BOTTLE (68788-7597-8) | February 13, 2020 |
| 68788-7597-9 | 68788-7597 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7597-9) | February 13, 2020 |
| 68788-7765-1 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-7765-1) | July 15, 2020 |
| 68788-7765-2 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 20 TABLET in 1 BOTTLE (68788-7765-2) | July 15, 2020 |
| 68788-7765-3 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-7765-3) | July 15, 2020 |
| 68788-7765-6 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-7765-6) | July 15, 2020 |
| 68788-7765-8 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 120 TABLET in 1 BOTTLE (68788-7765-8) | July 15, 2020 |
| 68788-7765-9 | 68788-7765 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-7765-9) | July 15, 2020 |
| 71205-530-30 | 71205-530 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-530-30) | February 3, 2021 |
| 71205-530-60 | 71205-530 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-530-60) | February 3, 2021 |
| 71205-530-90 | 71205-530 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-530-90) | February 3, 2021 |
| 71205-977-00 | 71205-977 | Proficient Rx LP | 100 TABLET in 1 BOTTLE, PLASTIC (71205-977-00) | May 7, 2020 |
| 71205-977-30 | 71205-977 | Proficient Rx LP | 30 TABLET in 1 BOTTLE, PLASTIC (71205-977-30) | May 7, 2020 |
| 71205-977-55 | 71205-977 | Proficient Rx LP | 500 TABLET in 1 BOTTLE, PLASTIC (71205-977-55) | May 7, 2020 |
| 71205-977-60 | 71205-977 | Proficient Rx LP | 60 TABLET in 1 BOTTLE, PLASTIC (71205-977-60) | May 7, 2020 |
| 71205-977-72 | 71205-977 | Proficient Rx LP | 120 TABLET in 1 BOTTLE, PLASTIC (71205-977-72) | May 7, 2020 |
| 71205-977-90 | 71205-977 | Proficient Rx LP | 90 TABLET in 1 BOTTLE, PLASTIC (71205-977-90) | May 7, 2020 |
| 71205-978-00 | 71205-978 | Proficient Rx LP | 100 TABLET in 1 BOTTLE, PLASTIC (71205-978-00) | May 7, 2020 |
| 71205-978-30 | 71205-978 | Proficient Rx LP | 30 TABLET in 1 BOTTLE, PLASTIC (71205-978-30) | May 7, 2020 |
| 71205-978-55 | 71205-978 | Proficient Rx LP | 500 TABLET in 1 BOTTLE, PLASTIC (71205-978-55) | May 7, 2020 |
| 71205-978-60 | 71205-978 | Proficient Rx LP | 60 TABLET in 1 BOTTLE, PLASTIC (71205-978-60) | May 7, 2020 |
| 71205-978-72 | 71205-978 | Proficient Rx LP | 120 TABLET in 1 BOTTLE, PLASTIC (71205-978-72) | May 7, 2020 |
| 71205-978-90 | 71205-978 | Proficient Rx LP | 90 TABLET in 1 BOTTLE, PLASTIC (71205-978-90) | May 7, 2020 |
| 55700-840-60 | 55700-840 | Quality Care Products, LLC | 60 TABLET in 1 BOTTLE (55700-840-60) | January 24, 2020 |
| 55700-845-60 | 55700-845 | Quality Care Products, LLC | 60 TABLET in 1 BOTTLE (55700-845-60) | February 28, 2020 |
| 70518-3835-0 | 70518-3835 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-3835-0) | August 18, 2023 |
| 70518-3835-1 | 70518-3835 | REMEDYREPACK INC. | 60 TABLET in 1 BOTTLE, PLASTIC (70518-3835-1) | March 12, 2024 |
| 70518-4047-0 | 70518-4047 | REMEDYREPACK INC. | 14 TABLET in 1 BOTTLE, PLASTIC (70518-4047-0) | April 7, 2024 |
| 70518-4047-1 | 70518-4047 | REMEDYREPACK INC. | 60 TABLET in 1 BOTTLE, PLASTIC (70518-4047-1) | May 16, 2024 |
| 70518-4047-2 | 70518-4047 | REMEDYREPACK INC. | 60 TABLET in 1 BOTTLE, PLASTIC (70518-4047-2) | February 23, 2026 |
| 67296-2137-3 | 67296-2137 | Redpharm Drug | 30 TABLET in 1 BOTTLE (67296-2137-3) | June 26, 2019 |
| 50228-465-01 | 50228-465 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-465-01) | June 26, 2019 |
| 50228-465-05 | 50228-465 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-465-05) | June 26, 2019 |
| 50228-465-30 | 50228-465 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-465-30) | June 26, 2019 |
| 50228-466-01 | 50228-466 | ScieGen Pharmaceuticals Inc | 100 TABLET in 1 BOTTLE (50228-466-01) | June 26, 2019 |
| 50228-466-05 | 50228-466 | ScieGen Pharmaceuticals Inc | 500 TABLET in 1 BOTTLE (50228-466-05) | June 26, 2019 |
| 50228-466-30 | 50228-466 | ScieGen Pharmaceuticals Inc | 30 TABLET in 1 BOTTLE (50228-466-30) | June 26, 2019 |
| 85766-261-01 | 85766-261 | Sportpharm LLC | 100 TABLET in 1 BOTTLE (85766-261-01) | August 19, 2026 |
| 85766-261-06 | 85766-261 | Sportpharm LLC | 6 TABLET in 1 BOTTLE (85766-261-06) | August 19, 2026 |
| 85766-261-07 | 85766-261 | Sportpharm LLC | 7 TABLET in 1 BOTTLE (85766-261-07) | August 19, 2026 |
| 85766-261-10 | 85766-261 | Sportpharm LLC | 10 TABLET in 1 BOTTLE (85766-261-10) | August 19, 2026 |
| 85766-261-20 | 85766-261 | Sportpharm LLC | 20 TABLET in 1 BOTTLE (85766-261-20) | August 19, 2026 |
| 85766-261-30 | 85766-261 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-261-30) | August 19, 2026 |
| 85766-261-60 | 85766-261 | Sportpharm LLC | 60 TABLET in 1 BOTTLE (85766-261-60) | August 19, 2026 |
| 85766-261-90 | 85766-261 | Sportpharm LLC | 90 TABLET in 1 BOTTLE (85766-261-90) | August 19, 2026 |
| 85766-262-01 | 85766-262 | Sportpharm LLC | 100 TABLET in 1 BOTTLE (85766-262-01) | August 19, 2026 |
| 85766-262-06 | 85766-262 | Sportpharm LLC | 6 TABLET in 1 BOTTLE (85766-262-06) | August 19, 2026 |
| 85766-262-07 | 85766-262 | Sportpharm LLC | 7 TABLET in 1 BOTTLE (85766-262-07) | August 19, 2026 |
| 85766-262-10 | 85766-262 | Sportpharm LLC | 10 TABLET in 1 BOTTLE (85766-262-10) | August 19, 2026 |
| 85766-262-20 | 85766-262 | Sportpharm LLC | 20 TABLET in 1 BOTTLE (85766-262-20) | August 19, 2026 |
| 85766-262-30 | 85766-262 | Sportpharm LLC | 30 TABLET in 1 BOTTLE (85766-262-30) | August 19, 2026 |
| 85766-262-60 | 85766-262 | Sportpharm LLC | 60 TABLET in 1 BOTTLE (85766-262-60) | August 19, 2026 |
| 85766-262-90 | 85766-262 | Sportpharm LLC | 90 TABLET in 1 BOTTLE (85766-262-90) | August 19, 2026 |
| 60760-368-15 | 60760-368 | St. Mary's Medical Park Pharmacy | 15 TABLET in 1 BOTTLE, PLASTIC (60760-368-15) | October 21, 2019 |
| 60760-368-60 | 60760-368 | St. Mary's Medical Park Pharmacy | 60 TABLET in 1 BOTTLE, PLASTIC (60760-368-60) | March 3, 2020 |
| 60760-369-14 | 60760-369 | St. Mary's Medical Park Pharmacy | 14 TABLET in 1 BOTTLE, PLASTIC (60760-369-14) | October 10, 2019 |
| 60760-369-60 | 60760-369 | St. Mary's Medical Park Pharmacy | 60 TABLET in 1 BOTTLE, PLASTIC (60760-369-60) | January 27, 2020 |
| 60760-369-90 | 60760-369 | St. Mary's Medical Park Pharmacy | 90 TABLET in 1 BOTTLE, PLASTIC (60760-369-90) | February 23, 2021 |
| 69367-241-01 | 69367-241 | Westminster Pharmaceuticals, LLC | 100 TABLET in 1 BOTTLE, PLASTIC (69367-241-01) | September 25, 2019 |
| 69367-241-05 | 69367-241 | Westminster Pharmaceuticals, LLC | 500 TABLET in 1 BOTTLE, PLASTIC (69367-241-05) | September 25, 2019 |
| 69367-242-01 | 69367-242 | Westminster Pharmaceuticals, LLC | 100 TABLET in 1 BOTTLE, PLASTIC (69367-242-01) | September 25, 2019 |
| 69367-242-05 | 69367-242 | Westminster Pharmaceuticals, LLC | 500 TABLET in 1 BOTTLE, PLASTIC (69367-242-05) | September 25, 2019 |
| 72189-072-14 | 72189-072 | direct rx | 14 TABLET in 1 BOTTLE (72189-072-14) | June 18, 2020 |
| 72189-072-30 | 72189-072 | direct rx | 30 TABLET in 1 BOTTLE (72189-072-30) | June 18, 2020 |
| 72189-072-60 | 72189-072 | direct rx | 60 TABLET in 1 BOTTLE (72189-072-60) | June 18, 2020 |
| 72189-184-14 | 72189-184 | direct rx | 14 TABLET in 1 BOTTLE (72189-184-14) | May 11, 2021 |
| 72189-184-30 | 72189-184 | direct rx | 30 TABLET in 1 BOTTLE (72189-184-30) | May 11, 2021 |
| 72189-184-60 | 72189-184 | direct rx | 60 TABLET in 1 BOTTLE (72189-184-60) | May 11, 2021 |
| 72189-184-90 | 72189-184 | direct rx | 90 TABLET in 1 BOTTLE (72189-184-90) | May 11, 2021 |
| 50090-5294 | 50090-5294 | A-S Medication Solutions | — | June 26, 2019 |
| 50090-6167 | 50090-6167 | A-S Medication Solutions | — | June 26, 2019 |
| 87063-292 | 87063-292 | ASCLEMED USA INC. | — | June 26, 2019 |
| 80425-0104 | 80425-0104 | Advanced Rx Pharmacy of Tennessee, LLC | — | June 26, 2019 |
| 80425-0054 | 80425-0054 | Advanced Rx of Tennessee, LLC | — | June 26, 2019 |
| 76420-210 | 76420-210 | Asclemed USA, Inc. | — | June 26, 2019 |
| 63629-8506 | 63629-8506 | Bryant Ranch Prepack | — | June 26, 2019 |
| 63629-8508 | 63629-8508 | Bryant Ranch Prepack | — | June 26, 2019 |
| 63629-8509 | 63629-8509 | Bryant Ranch Prepack | — | June 26, 2019 |
| 63629-8510 | 63629-8510 | Bryant Ranch Prepack | — | June 26, 2019 |
| 71335-1391 | 71335-1391 | Bryant Ranch Prepack | — | June 26, 2019 |
| 71335-1559 | 71335-1559 | Bryant Ranch Prepack | — | June 26, 2019 |
| 71335-2292 | 71335-2292 | Bryant Ranch Prepack | — | June 26, 2019 |
| 71335-2293 | 71335-2293 | Bryant Ranch Prepack | — | June 26, 2019 |
| 72162-1557 | 72162-1557 | Bryant Ranch Prepack | — | June 26, 2019 |
| 72162-1558 | 72162-1558 | Bryant Ranch Prepack | — | June 26, 2019 |
| 51655-446 | 51655-446 | Northwind Health Company, LLC | — | October 2, 2020 |
| 51655-733 | 51655-733 | Northwind Health Company, LLC | — | July 7, 2021 |
| 72789-040 | 72789-040 | PD-Rx Pharmaceuticals, Inc. | — | June 26, 2019 |
| 72789-540 | 72789-540 | PD-Rx Pharmaceuticals, Inc. | — | June 26, 2019 |
| 68788-7597 | 68788-7597 | Preferred Pharmaceuticals Inc. | — | February 13, 2020 |
| 68788-7765 | 68788-7765 | Preferred Pharmaceuticals, Inc. | — | July 15, 2020 |
| 71205-530 | 71205-530 | Proficient Rx LP | — | June 26, 2019 |
| 71205-977 | 71205-977 | Proficient Rx LP | — | September 25, 2019 |
| 71205-978 | 71205-978 | Proficient Rx LP | — | September 25, 2019 |
| 55700-840 | 55700-840 | Quality Care Products, LLC | — | June 26, 2019 |
| 55700-845 | 55700-845 | Quality Care Products, LLC | — | February 28, 2020 |
| 70518-3835 | 70518-3835 | REMEDYREPACK INC. | — | August 18, 2023 |
| 70518-4047 | 70518-4047 | REMEDYREPACK INC. | — | April 7, 2024 |
| 67296-2137 | 67296-2137 | Redpharm Drug | — | June 26, 2019 |
| 50228-465 | 50228-465 | ScieGen Pharmaceuticals Inc | — | June 26, 2019 |
| 50228-466 | 50228-466 | ScieGen Pharmaceuticals Inc | — | June 26, 2019 |
| 85766-261 | 85766-261 | Sportpharm LLC | — | June 26, 2019 |
| 85766-262 | 85766-262 | Sportpharm LLC | — | June 26, 2019 |
| 60760-368 | 60760-368 | St. Mary's Medical Park Pharmacy | — | October 21, 2019 |
| 60760-369 | 60760-369 | St. Mary's Medical Park Pharmacy | — | October 10, 2019 |
| 69367-241 | 69367-241 | Westminster Pharmaceuticals, LLC | — | September 25, 2019 |
| 69367-242 | 69367-242 | Westminster Pharmaceuticals, LLC | — | September 25, 2019 |
| 72189-072 | 72189-072 | direct rx | — | June 18, 2020 |
| 72189-184 | 72189-184 | direct rx | — | May 11, 2021 |
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.