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diclofenac potassium
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 |
|---|---|---|---|---|---|---|---|
| 215750-001 | DICLOFENAC POTASSIUM | TABLET | DICLOFENAC POTASSIUM | Prescription | AB | ||
| 215750-002 | DICLOFENAC POTASSIUM | TABLET | DICLOFENAC POTASSIUM | 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 | 8 | Manufacturing (CMC) | Approved | June 30, 2025 | Unknown |
| Supplement | 7 | Labeling | Approved | November 21, 2024 | Standard |
| Original application | 1 | Approved | May 11, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260515). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: 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 Potassium Tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS , 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 Carefully consider the potential benefits and risks of diclofenac potassium tablets and other treatment options before deciding to use diclofenac potassium tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see Error! Hyperlink reference not valid. Gastrointestinal Bleeding, Ulceration, and Perforation ). Diclofenac potassium tablets are indicated: • for treatment of primary dysmenorrhea • for relief of mild to moderate pain • for relief of the signs and symptoms of osteoarthritis • for relief of the signs and symptoms of rheumatoid arthritis
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of diclofenac potassium immediate-release tablets and other treatment options before deciding to use diclofenac potassium 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 potassium tablets, the dose and frequency should be adjusted to suit an individual patient’s needs. For treatment of pain or primary dysmenorrhea the recommended dosage is 50 mg three times a day. With experience, physicians may find that in some patients an initial dose of 100 mg of diclofenac potassium tablets, followed by 50-mg doses, will provide better relief. For the relief of osteoarthritis the recommended dosage is 100 to 150 mg/day in divided doses, 50 mg twice a day. or three times a day. For the relief of rheumatoid arthritis the recommended dosage is 150 to 200 mg/day in divided doses, 50 mg three times a day or four times a day. Different formulations of diclofenac [VOLTAREN ® (diclofenac sodium enteric-coated tablets); Voltaren ® -XR (diclofenac sodium extended-release tablets); diclofenac potassium immediate release tablets] are not necessarily bioequivalent even if the milligram strength is the same.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Diclofenac potassium 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 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
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 potassium tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac potassium 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 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 p …
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 718 patients treated for shorter periods, i.e., 2 weeks or less, with diclofenac potassium tablets, adverse reactions were reported one-half to one-tenth as frequently as by patients treated for longer periods. In a 6-month, double-blind trial comparing diclofenac potassium tablets (N = 196) versus diclofenac sodium delayed-release tablets (N = 197) versus ibuprofen (N = 197), adverse reactions were similar in nature and frequency. In patients taking diclofenac potassium 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 Respiratory System: asthma, dyspnea Skin and Appendages: alopecia, photosensitivity, sweating increased Special Senses: blurred vision Urogenital System: cystitis, dysuria, hematuria, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure 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 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 necrolysis, erythema multiforme, exfoliative dermatitis, Stevens-Johnson Syndrome, urticaria Special Senses: conjunctivitis, hearing impairment To report SUSPECTED ADVERSE EVENTS , contact Amici Pharmaceuticals LLC. at 1-877-938-4525 or FDA at 1- 800- FDA-1088 or http://www.fda.gov/medwatch for voluntary reporting of adverse reactions.
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 potassium 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 WARNINGS; 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 potassium tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding (see WARNINGS; Hematologic Toxicity ). Diclofenac potassium 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 potassium tablets and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained. • During concomitant use of diclofenac potassium tablets 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 postmarketing 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 potassium tablets 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 potassium 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 con …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac potassium 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 potassium tablets, USP are a benzeneacetic acid derivative. Diclofenac potassium tablets USP, 50 mg are available as orange, film-coated tablets for oral administration. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid, monopotassium salt. The structural formula is: C 14 H 10 Cl 2 KNO 2 M.W. 334.24 g/mol Diclofenac potassium, USP is a faintly yellowish white to light beige, virtually odorless, slightly hygroscopic crystalline powder. It is freely soluble in methanol, soluble in ethanol and water, and practically insoluble in chloroform and in dilute acid. The n-octanol/water partition coefficient is 13.4 at pH 7.4 and 1545 at pH 5.2. It has a single dissociation constant (pKa) of 4.0 ± 0.2 at 25°C in water. Each tablet, for oral administration, contains 50 mg of diclofenac potassium. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 4000, povidone, sodium starch glycolate, titanium dioxide, and tricalcium phosphate. 1
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 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 Potassium Tablets, USP are available containing 25 mg and 50 mg of diclofenac potassium, USP. The 25 mg tablets are white to off-white, round, biconvex, film coated tablets debossed with ‘DP’ on one side and ‘25’ on other side. 25 mg- Bottle of 30 tablets - NDC 60290-088-01 with child-resistant closure Bottle of 60 tablets - NDC 60290-088-05 with child-resistant closure Bottle of 100 tablets - NDC 60290-088-02 with child-resistant closure Bottle of 500 tablets - NDC 60290-088-03 Bottle of 1000 tablets - NDC 60290-088-04 Diclofenac Potassium Tablets, USP are available containing 50 mg of diclofenac potassium, USP. The 50 mg tablets are white to off-white, round, biconvex, film coated tablets debossed with ‘DP’ on one side and ‘50’ on other side. 50 mg- Bottle of 100 tablets - NDC 60290-057-01 with child-resistant closure Bottle of 500 tablets - NDC 60290-057-03 Bottle of 1000 tablets - NDC 60290-057-02 Store and dispense in tight, light- resistant container as defined in the USP. Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from moisture Manufactured by: Umedica Laboratories Pvt. Ltd. Vapi, Gujarat 396195, INDIA. Distributed by: Umedica Laboratories USA Inc. Parsippany, NJ, 07054. Product of India Rev: 03/2026
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DICLOFENAC POTASSIUM. 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 |
|---|---|---|---|---|
| 50090-6768-0 | 50090-6768 | A-S Medication Solutions | 30 TABLET, FILM COATED in 1 BOTTLE (50090-6768-0) | October 23, 2023 |
| 50090-6768-1 | 50090-6768 | A-S Medication Solutions | 21 TABLET, FILM COATED in 1 BOTTLE (50090-6768-1) | October 23, 2023 |
| 50090-6768-4 | 50090-6768 | A-S Medication Solutions | 90 TABLET, FILM COATED in 1 BOTTLE (50090-6768-4) | October 23, 2023 |
| 80425-0456-1 | 80425-0456 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-1) | December 15, 2024 |
| 80425-0456-2 | 80425-0456 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-2) | December 15, 2024 |
| 80425-0456-3 | 80425-0456 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0456-3) | December 15, 2024 |
| 80425-0457-1 | 80425-0457 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-1) | October 21, 2024 |
| 80425-0457-2 | 80425-0457 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-2) | October 21, 2024 |
| 80425-0457-3 | 80425-0457 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0457-3) | October 21, 2024 |
| 69292-548-30 | 69292-548 | Amici Pharma Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-548-30) | April 18, 2024 |
| 69292-550-01 | 69292-550 | Amici Pharma Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69292-550-01) | December 11, 2020 |
| 72819-151-10 | 72819-151 | Archis Pharma LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72819-151-10) | September 15, 2021 |
| 42291-042-01 | 42291-042 | AvKARE | 100 TABLET, FILM COATED in 1 BOTTLE (42291-042-01) | September 11, 2024 |
| 63629-4108-1 | 63629-4108 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (63629-4108-1) | December 2, 2009 |
| 63629-4108-2 | 63629-4108 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-4108-2) | April 20, 2010 |
| 63629-4108-3 | 63629-4108 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (63629-4108-3) | May 25, 2010 |
| 63629-4108-4 | 63629-4108 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (63629-4108-4) | January 6, 2011 |
| 63629-4108-5 | 63629-4108 | Bryant Ranch Prepack | 45 TABLET, FILM COATED in 1 BOTTLE (63629-4108-5) | December 22, 2021 |
| 63629-4108-6 | 63629-4108 | Bryant Ranch Prepack | 58 TABLET, FILM COATED in 1 BOTTLE (63629-4108-6) | December 22, 2021 |
| 63629-4108-7 | 63629-4108 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (63629-4108-7) | December 22, 2021 |
| 63629-4108-8 | 63629-4108 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (63629-4108-8) | December 22, 2021 |
| 71335-2530-1 | 71335-2530 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2530-1) | November 25, 2024 |
| 71335-2530-2 | 71335-2530 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2530-2) | November 25, 2024 |
| 71335-2530-3 | 71335-2530 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2530-3) | November 25, 2024 |
| 71335-2530-4 | 71335-2530 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2530-4) | November 25, 2024 |
| 71335-2530-5 | 71335-2530 | Bryant Ranch Prepack | 45 TABLET, FILM COATED in 1 BOTTLE (71335-2530-5) | November 25, 2024 |
| 71335-2530-6 | 71335-2530 | Bryant Ranch Prepack | 58 TABLET, FILM COATED in 1 BOTTLE (71335-2530-6) | November 25, 2024 |
| 71335-2530-7 | 71335-2530 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (71335-2530-7) | November 25, 2024 |
| 71335-2530-8 | 71335-2530 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2530-8) | November 25, 2024 |
| 71335-2530-9 | 71335-2530 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2530-9) | November 25, 2024 |
| 71335-9720-1 | 71335-9720 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-9720-1) | April 9, 2026 |
| 71335-9720-2 | 71335-9720 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-9720-2) | October 17, 2023 |
| 71335-9720-3 | 71335-9720 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9720-3) | May 11, 2023 |
| 71335-9720-4 | 71335-9720 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE (71335-9720-4) | November 15, 2023 |
| 71335-9720-5 | 71335-9720 | Bryant Ranch Prepack | 45 TABLET, FILM COATED in 1 BOTTLE (71335-9720-5) | April 9, 2026 |
| 71335-9720-6 | 71335-9720 | Bryant Ranch Prepack | 58 TABLET, FILM COATED in 1 BOTTLE (71335-9720-6) | April 9, 2026 |
| 71335-9720-7 | 71335-9720 | Bryant Ranch Prepack | 18 TABLET, FILM COATED in 1 BOTTLE (71335-9720-7) | April 9, 2026 |
| 71335-9720-8 | 71335-9720 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE (71335-9720-8) | April 9, 2026 |
| 71335-9720-9 | 71335-9720 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-9720-9) | April 9, 2026 |
| 15370-185-30 | 15370-185 | Carwin Pharmaceutical Associates, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-30) | November 1, 2023 |
| 15370-185-60 | 15370-185 | Carwin Pharmaceutical Associates, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (15370-185-60) | April 8, 2025 |
| 69306-750-03 | 69306-750 | Doc Rx | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (69306-750-03) | November 7, 2025 |
| 51407-443-01 | 51407-443 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-443-01) | April 9, 2021 |
| 50742-279-01 | 50742-279 | Ingenus Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-279-01) | October 11, 2021 |
| 10135-806-01 | 10135-806 | Marlex Pharmaceuticals, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (10135-806-01) | March 1, 2025 |
| 75834-337-30 | 75834-337 | NIVAGEN PHARMACEUTICALS, INC. | 30 TABLET, FILM COATED in 1 BOTTLE (75834-337-30) | October 10, 2025 |
| 75834-337-60 | 75834-337 | NIVAGEN PHARMACEUTICALS, INC. | 60 TABLET, FILM COATED in 1 BOTTLE (75834-337-60) | October 10, 2025 |
| 66267-070-30 | 66267-070 | NuCare Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (66267-070-30) | September 29, 2016 |
| 66267-070-60 | 66267-070 | NuCare Pharmaceuticals, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (66267-070-60) | September 29, 2016 |
| 68071-3718-3 | 68071-3718 | NuCare Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68071-3718-3) | November 11, 2024 |
| 68071-3451-3 | 68071-3451 | NuCare Pharmaceuticals,Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68071-3451-3) | July 5, 2023 |
| 43063-848-21 | 43063-848 | PD-Rx Pharmaceuticals, Inc. | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-21) | April 12, 2018 |
| 43063-848-30 | 43063-848 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-848-30) | April 12, 2018 |
| 85509-1900-1 | 85509-1900 | PHOENIX RX LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-1) | January 12, 2026 |
| 85509-1900-3 | 85509-1900 | PHOENIX RX LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-3) | November 7, 2025 |
| 85509-1900-6 | 85509-1900 | PHOENIX RX LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-6) | January 12, 2026 |
| 85509-1900-9 | 85509-1900 | PHOENIX RX LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-1900-9) | January 12, 2026 |
| 85509-2750-1 | 85509-2750 | Phoenix RX LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-2750-1) | November 5, 2025 |
| 85509-2750-3 | 85509-2750 | Phoenix RX LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-2750-3) | October 29, 2025 |
| 85509-2750-6 | 85509-2750 | Phoenix RX LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-2750-6) | October 29, 2025 |
| 85509-2750-9 | 85509-2750 | Phoenix RX LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85509-2750-9) | October 29, 2025 |
| 68788-8411-3 | 68788-8411 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8411-3) | April 30, 2025 |
| 68788-8411-6 | 68788-8411 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (68788-8411-6) | April 30, 2025 |
| 68788-8411-9 | 68788-8411 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8411-9) | April 30, 2025 |
| 68788-8697-3 | 68788-8697 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-3) | June 24, 2024 |
| 68788-8697-6 | 68788-8697 | Preferred Pharmaceuticals Inc. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-6) | June 24, 2024 |
| 68788-8697-9 | 68788-8697 | Preferred Pharmaceuticals Inc. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8697-9) | June 24, 2024 |
| 70518-3538-3 | 70518-3538 | REMEDYREPACK INC. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3538-3) | April 6, 2023 |
| 70512-750-10 | 70512-750 | SOLA Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-10) | October 21, 2024 |
| 70512-750-50 | 70512-750 | SOLA Pharmaceuticals, LLC | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-750-50) | December 31, 2024 |
| 70512-900-30 | 70512-900 | SOLA Pharmaceuticals, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70512-900-30) | November 1, 2024 |
| 0093-0948-01 | 0093-0948 | Teva Pharmaceuticals USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0948-01) | August 11, 1998 |
| 0093-0948-05 | 0093-0948 | Teva Pharmaceuticals USA, Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0948-05) | August 11, 1998 |
| 60290-057-01 | 60290-057 | Umedica Laboratories USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (60290-057-01) | May 12, 2022 |
| 60290-057-02 | 60290-057 | Umedica Laboratories USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (60290-057-02) | May 12, 2022 |
| 60290-057-03 | 60290-057 | Umedica Laboratories USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (60290-057-03) | May 12, 2022 |
| 60290-088-01 | 60290-088 | Umedica Laboratories USA Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (60290-088-01) | September 28, 2024 |
| 60290-088-02 | 60290-088 | Umedica Laboratories USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (60290-088-02) | September 28, 2024 |
| 60290-088-03 | 60290-088 | Umedica Laboratories USA Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (60290-088-03) | September 28, 2024 |
| 60290-088-04 | 60290-088 | Umedica Laboratories USA Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (60290-088-04) | September 28, 2024 |
| 60290-088-05 | 60290-088 | Umedica Laboratories USA Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (60290-088-05) | October 30, 2025 |
| 70710-1832-0 | 70710-1832 | Zydus Pharmaceuticals (USA) Inc. | 1000 TABLET, FILM COATED in 1 BOTTLE (70710-1832-0) | May 12, 2022 |
| 70710-1832-1 | 70710-1832 | Zydus Pharmaceuticals (USA) Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1832-1) | May 12, 2022 |
| 70710-1832-5 | 70710-1832 | Zydus Pharmaceuticals (USA) Inc. | 500 TABLET, FILM COATED in 1 BOTTLE (70710-1832-5) | May 12, 2022 |
| 50090-6768 | 50090-6768 | A-S Medication Solutions | — | May 12, 2022 |
| 80425-0456 | 80425-0456 | Advanced Rx of Tennessee, LLC | — | December 15, 2024 |
| 80425-0457 | 80425-0457 | Advanced Rx of Tennessee, LLC | — | October 21, 2024 |
| 69292-548 | 69292-548 | Amici Pharma Inc. | — | April 18, 2024 |
| 69292-550 | 69292-550 | Amici Pharma Inc. | — | December 11, 2020 |
| 72819-151 | 72819-151 | Archis Pharma LLC | — | September 15, 2021 |
| 42291-042 | 42291-042 | AvKARE | — | September 11, 2024 |
| 63629-4108 | 63629-4108 | Bryant Ranch Prepack | — | August 11, 1998 |
| 71335-2530 | 71335-2530 | Bryant Ranch Prepack | — | October 11, 2021 |
| 71335-9720 | 71335-9720 | Bryant Ranch Prepack | — | May 12, 2022 |
| 15370-185 | 15370-185 | Carwin Pharmaceutical Associates, LLC | — | November 1, 2023 |
| 69306-750 | 69306-750 | Doc Rx | — | October 21, 2024 |
| 51407-443 | 51407-443 | Golden State Medical Supply, Inc. | — | March 18, 2004 |
| 50742-279 | 50742-279 | Ingenus Pharmaceuticals, LLC | — | October 11, 2021 |
| 10135-806 | 10135-806 | Marlex Pharmaceuticals, Inc. | — | March 1, 2025 |
| 75834-337 | 75834-337 | NIVAGEN PHARMACEUTICALS, INC. | — | October 10, 2025 |
| 66267-070 | 66267-070 | NuCare Pharmaceuticals, Inc. | — | August 11, 1998 |
| 68071-3718 | 68071-3718 | NuCare Pharmaceuticals, Inc. | — | September 15, 2021 |
| 68071-3451 | 68071-3451 | NuCare Pharmaceuticals,Inc. | — | May 12, 2022 |
| 43063-848 | 43063-848 | PD-Rx Pharmaceuticals, Inc. | — | August 11, 1998 |
| 85509-1900 | 85509-1900 | PHOENIX RX LLC | — | November 1, 2024 |
| 85509-2750 | 85509-2750 | Phoenix RX LLC | — | October 21, 2024 |
| 68788-8411 | 68788-8411 | Preferred Pharmaceuticals Inc. | — | April 30, 2025 |
| 68788-8697 | 68788-8697 | Preferred Pharmaceuticals Inc. | — | June 24, 2024 |
| 70518-3538 | 70518-3538 | REMEDYREPACK INC. | — | September 26, 2022 |
| 70512-750 | 70512-750 | SOLA Pharmaceuticals, LLC | — | October 21, 2024 |
| 70512-900 | 70512-900 | SOLA Pharmaceuticals, LLC | — | November 1, 2024 |
| 0093-0948 | 0093-0948 | Teva Pharmaceuticals USA, Inc. | — | August 11, 1998 |
| 60290-057 | 60290-057 | Umedica Laboratories USA Inc. | — | May 12, 2022 |
| 60290-088 | 60290-088 | Umedica Laboratories USA Inc. | — | May 12, 2022 |
| 70710-1832 | 70710-1832 | Zydus Pharmaceuticals (USA) Inc. | — | May 12, 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 |
Generated September 25, 2026 · 12 sections on this page.