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Diclofenac Sodium
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Diclofenac Sodium | 100 mg/1 | 855633 | View |
Forms, 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 |
|---|---|---|---|---|---|---|---|
| 075492-001 | DICLOFENAC SODIUM | TABLET, EXTENDED RELEASE | DICLOFENAC SODIUM | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | November 21, 2024 | Standard |
| Supplement | 14 | Labeling | Approved | April 29, 2021 | Standard |
| Supplement | 13 | Labeling | Approved | March 26, 2021 | Standard |
| Supplement | 6 | Labeling | Approved | July 30, 2010 | — |
| Supplement | 5 | Labeling | Approved | January 8, 2007 | — |
| Supplement | 3 | Manufacturing (CMC) | Approved | December 14, 2001 | — |
| Supplement | 2 | Manufacturing (CMC) | Approved | June 8, 2001 | — |
| Supplement | 1 | Manufacturing (CMC) | Approved | June 8, 2001 | — |
| Original application | 1 | Approved | February 11, 2000 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260902). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingBoxed Warning WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS Cardiovascular Thrombotic Events • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use (see WARNINGS). • Diclofenac Sodium Extended-release 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 sodium extended-release tablets and other treatment options before deciding to use diclofenac sodium extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Diclofenac Sodium Extended-release Tablets are indicated: • 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 sodium extended-release tablets, and other treatment options before deciding to use diclofenac sodium extended-release 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 diclofenac sodium extended-release tablets the dose and frequency should be adjusted to suit an individual patient’s needs. For the relief of osteoarthritis, the recommended dosage is 100-mg daily. For the relief of rheumatoid arthritis, the recommended dosage is 100-mg daily. In the rare patient where diclofenac sodium extended-release tablets 100 mg/day is unsatisfactory, the dose may be increased to 100 mg twice a day, if the benefits outweigh the clinical risks of increased side effects. Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; 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 Sodium Extended-release Tablets are contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product ( see WARNINGS ; Anaphylactic Reactions , Serious Skin Reactions ). History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients ( see WARNINGS, Anaphylactic Reactions , PRECAUTIONS; Exacerbation of Asthma Related to Aspirin Sensitivity). In the setting of coronary artery bypass graft (CABG) surgery ( see WARNINGS ; Cardiovascular Thrombotic Events ).
Warnings and Cautions
openFDA Drug LabelingWarnings and Precautions Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as diclofenac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS; GASTROINTESTINAL BLEEDING, ULCERATION, AND PERFORATION). Status Post-Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled, clinical trials of 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 sodium extended-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If diclofenac sodium extended-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including diclofenac, can cause serious gastrointestinal (GI) adverse events, including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased ris …
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, myocardial infarction, and stroke, which can be fatal. All NSAIDs, both COX-2 selective and nonselective, may have a similar risk. Patients with known CV disease or risk factors for CV disease may be at greater risk. To minimize the potential risk for an adverse CV event in patients treated with an NSAID, the lowest effective dose should be used for the shortest duration possible. Physicians and patients should remain alert for the development of such events, even in the absence of previous CV symptoms. Patients should be informed about the signs and/or 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 does increase the risk of serious gastrointestinal events (see WARNINGS, Gastrointestinal (GI) Effects : Risk of GI Ulceration, Bleeding, and Perforation ). Two large, controlled, clinical trials of COX-2 selective NSAID for the treatment of pain in the first 10 to14 days following CABG surgery found an increased incidence of myocardial infarction and stroke (see CONTRAINDICATIONS ). Hypertension NSAIDs 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 Diclofenac Sodium Extended-release Tablets, should be used with caution in patients with hypertension. Blood pressure (BP) should be monitored closely during the initiation of NSAID treatment and throughout the course of therapy. Congestive Heart Failure and Edema Fluid retention and edema have been observed in some patients taking NSAIDs. Diclofenac Sodium Extended-release Tablets should be used with caution in patients with fluid retention or heart failure. Gastrointestinal (GI) Effects: Risk of GI Ulceration, Bleeding, and Perforation NSAIDs, including Diclofenac Sodium Extended-release Tablets, can cause serious GI adverse events including inflammation, bleeding, ulceration, and perforation of the 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 occur in approximately 1% of patients treated for 3 to 6 months and in about 2 to 4% of patients treated for one year. These trends continue with longer duration of use, increasing the likelihood of developing a serious GI event at some time during the course of therapy. However, even short-term therapy is not without risk. NSAIDs should be prescribed with extreme caution in those with a prior history of ulcer disease or gastrointestinal bleeding. Patients with a prior history of peptic ulcer disease and/or gastrointestinal bleeding who use NSAIDs have a greater than 10-fold increased risk for developing a GI bleed compared to patients with neither of these risk factors. Other factors that increase the risk for GI bleeding in patients treated with NSAIDs include concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAID therapy, smoking, use of alcohol, older age, and poor general health status. Most spontaneous reports of fatal GI events are in elderly or debilitated patients and, therefore, special care should be taken in treating this population. To minimize the potential risk for an adverse GI event in patients treated with an NSAID, the …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS The following adverse reactions are discussed in greater detail in other sections of the labeling: • Cardiovascular Thrombotic Events ( see WARNINGS ) • GI Bleeding, Ulceration, and Perforation ( see WARNINGS ) • Hepatotoxicity ( see WARNINGS ) • Hypertension ( see WARNINGS ) • Heart Failure and Edema ( see WARNINGS ) • Renal Toxicity and Hyperkalemia ( see WARNINGS ) • Anaphylactic Reactions ( see WARNINGS ) • Serious Skin Reactions ( see WARNINGS ) • Hematologic Toxicity ( see WARNINGS ) Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients taking diclofenac sodium extended-release tablets 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) 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, fixed drug eruption (FDE), urticaria Special Senses: conjunctivitis, hearing impairment To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug LabelingDrug Interactions See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone. Intervention: Monitor patients with concomitant use of Diclofenac Sodium Extended-release Tablets with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding ( see WARNINGS; Hematological Toxicity ) . Aspirin Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone ( see WARNINGS; Gastrointestinal Bleeding, Ulceration, and Perforation ). Intervention: Concomitant use of Diclofenac Sodium Extended-release Tablets and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding ( see WARNINGS; Hematological Toxicity ). Diclofenac Sodium Extended-release Tablets are not a substitute for low dose aspirin for cardiovascular protection. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers Clinical Impact: NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol). In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Intervention: During concomitant use of Diclofenac Sodium Extended-release 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 Sodium Extended-release 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 post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis. Intervention: During concomitant use of Diclofenac Sodium Extended-release 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 Sodium Extended-release Tablets and digoxin, monitor serum digoxin levels. Lithium Clinical Impact: NSAIDs have produced elevations in …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Diclofenac Sodium Extended-release Tablets have analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac sodium extended-release tablets, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Description
openFDA Drug LabelingDESCRIPTION: Diclofenac sodium extended-release tablets, USP are a benzene-acetic acid derivative. Diclofenac sodium extended-release tablets, USP are available as film-coated tablets of 100 mg (yellow) for oral administration. Diclofenac sodium, USP is a white to off-white hygroscopic, crystalline powder and is freely soluble in methanol, soluble in ethanol, sparingly soluble in water, practically insoluble in chloroform and in ether. The chemical name is Sodium [ o -(2,6-dichloroanilino)phenyl]acetate. The molecular weight is 318.13 g/mol. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 and it has the following structural formula: The inactive ingredients in diclofenac sodium extended-release tablets, USP include: hydroxyethyl cellulose, hypromellose, iron oxide yellow, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone and titanium dioxide. Meets USP Dissolution Test 4. Chemical Structure
Overdosage
openFDA Drug LabelingOVERDOSAGE: Symptoms following acute NSAID overdosages have been typically limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which have been generally reversible with supportive care. Gastrointestinal bleeding has occurred. Hypertension, acute renal failure, respiratory depression and coma have occurred, but were rare (see WARNINGS: Cardiovascular Thrombotic Events , Gastrointestinal Bleeding, Ulceration, and Perforation , Hypertension , Renal Toxicity and Hyperkalemia ). Manage patients with symptomatic and supportive care following an NSAID overdosage. There are no specific antidotes. Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1 to 2 grams per kg in pediatric patients) and/or osmotic cathartic in symptomatic patients seen within four hours of ingestion or in patients with a large overdose (5 to 10 times the recommended dosage). Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding. For additional information about overdosage treatment, contact a poison control center (1-800-222-1222).
How Supplied / Storage and Handling
openFDA Drug LabelingHow Supplied/Storage and Handling Diclofenac Sodium Extended-release Tablets are available as follows: 100 mg – unscored, pink, round film coated tablets, engraved with “93” on one side and “1041” on the other side. Bottles of 30 Tablets NDC:80425-0210-01 Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in tight container (USP). Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada © 2021 Bausch Health Companies Inc. or its affiliates 9493404 Revised: 05/2021 Distributed by: Advanced Rx Pharmacy of Tennessee, LLC Nashville, TN 37217
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: DICLOFENAC SODIUM. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-4172-1 | 50090-4172 | A-S Medication Solutions | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4172-1) | March 7, 2019 |
| 80425-0210-1 | 80425-0210 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (80425-0210-1) | November 4, 2023 |
| 84386-103-01 | 84386-103 | Aurobindo Pharma Limited | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (84386-103-01) | July 16, 2026 |
| 71335-0648-1 | 71335-0648 | Bryant Ranch Prepack | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-1) | May 22, 2018 |
| 71335-0648-2 | 71335-0648 | Bryant Ranch Prepack | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-2) | April 13, 2018 |
| 71335-0648-3 | 71335-0648 | Bryant Ranch Prepack | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-3) | January 29, 2025 |
| 71335-0648-4 | 71335-0648 | Bryant Ranch Prepack | 14 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-4) | July 23, 2018 |
| 71335-0648-5 | 71335-0648 | Bryant Ranch Prepack | 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-5) | October 13, 2022 |
| 71335-0648-6 | 71335-0648 | Bryant Ranch Prepack | 21 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-6) | July 3, 2018 |
| 71335-0648-7 | 71335-0648 | Bryant Ranch Prepack | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-7) | April 16, 2019 |
| 71335-0648-8 | 71335-0648 | Bryant Ranch Prepack | 120 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-8) | January 29, 2025 |
| 71335-0648-9 | 71335-0648 | Bryant Ranch Prepack | 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71335-0648-9) | January 29, 2025 |
| 68071-2223-7 | 68071-2223 | NuCare Pharmaceuticals,Inc. | 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68071-2223-7) | July 30, 2020 |
| 68682-103-01 | 68682-103 | Oceanside Pharmaceuticals | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68682-103-01) | February 28, 2000 |
| 63187-994-15 | 63187-994 | Proficient Rx LP | 15 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-15) | March 1, 2018 |
| 63187-994-20 | 63187-994 | Proficient Rx LP | 20 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-20) | March 1, 2018 |
| 63187-994-30 | 63187-994 | Proficient Rx LP | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-30) | March 1, 2018 |
| 63187-994-60 | 63187-994 | Proficient Rx LP | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-60) | March 1, 2018 |
| 63187-994-90 | 63187-994 | Proficient Rx LP | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63187-994-90) | March 1, 2018 |
| 50090-4172 | 50090-4172 | A-S Medication Solutions | — | February 28, 2000 |
| 80425-0210 | 80425-0210 | Advanced Rx Pharmacy of Tennessee, LLC | — | November 4, 2022 |
| 84386-103 | 84386-103 | Aurobindo Pharma Limited | — | July 16, 2026 |
| 71335-0648 | 71335-0648 | Bryant Ranch Prepack | — | February 28, 2000 |
| 68071-2223 | 68071-2223 | NuCare Pharmaceuticals,Inc. | — | February 28, 2000 |
| 68682-103 | 68682-103 | Oceanside Pharmaceuticals | — | February 28, 2000 |
| 63187-994 | 63187-994 | Proficient Rx LP | — | February 28, 2000 |
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.