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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 |
|---|---|---|---|---|---|---|---|
| 216275-001 | 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 | 2 | Labeling | Approved | November 21, 2024 | Standard |
| Original application | 1 | Approved | September 23, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260206). 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 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 [VOLTAREN ® (diclofenac sodium enteric-coated tablets); diclofenac sodium extended-release tablets; CATAFLAM ® (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 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
openFDA Drug LabelingWARNINGS Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to 3 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 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 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 deve …
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 Ingenus Pharmaceuticals, LLC at 1-877-748-1970 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug LabelingDrug Interaction Studies Voriconazole : When coadministered with voriconazole (inhibitor of CYP2C9, 2C19, and 3A4 enzyme), the C max and AUC of diclofenac increased by 114% and 78%, respectively (see PRECAUTIONS ; Drug Interactions ). Aspirin : When NSAIDs were administered with aspirin, the protein binding of NSAIDs were reduced, although the clearance of free NSAID was not altered. The clinical significance of this interaction is not known. See Table 2 for clinically significant drug interactions of NSAIDs with aspirin (see PRECAUTIONS ; Drug Interactions ).
Drug 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 (ses 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, coadministration 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-rel …
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 is a benzeneacetic acid derivative. Diclofenac sodium extended-release tablets are available as extended-release tablets of 100 mg (pink) for oral administration. Diclofenac sodium is a white to off-white, hygroscopic, crystalline powder and is sparingly soluble in water at 25°C. The chemical name is 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt. The molecular weight is 318.14 g/mol. Its molecular formula is C 14 H 10 Cl 2 NNaO 2 , and it has the following structural formula The inactive ingredients in diclofenac sodium extended-release tablets include: anhydrous lactose, hydroxyethyl cellulose, povidone, colloidal silicon dioxide, talc, magnesium stearate, hypromellose, titanium dioxide, macrogol, iron oxide red, polysorbate 80. Diclofenac sodium extended-release tablets, USP meet USP Dissolution Test 5. image description
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 Diclofenac sodium extended-release tablets, USP 100 mg – Pink, round, convex film coated tablets debossed with ING on one side and 278 on the other side. Bottles of 7: NDC 76420-598-07 (repackaged from NDC 50742-278-01) Bottles of 14: NDC 76420-598-14 (repackaged from NDC 50742-278-01) Bottles of 20: NDC 76420-598-20 (repackaged from NDC 50742-278-01) Bottles of 30: NDC 76420-598-30 (repackaged from NDC 50742-278-01) Bottles of 60: NDC 76420-598-60 (repackaged from NDC 50742-278-01) Bottles of 90: NDC 76420-598-90 (repackaged from NDC 50742-278-01) Bottles of 100: NDC 76420-598-10 (relabeled from NDC 50742-278-01) Preserve in well-closed containers. Store at room temperature 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light and moisture. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501 Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-sodium-er-tablets.pdf ingenus Dispense with Medication Guide available at: www.ingenus.com/medguide/diclofenac-sodium-er-tablets.pdf
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 |
|---|---|---|---|---|
| 80425-0414-1 | 80425-0414 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-1) | July 11, 2024 |
| 80425-0414-2 | 80425-0414 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-2) | July 11, 2024 |
| 80425-0414-3 | 80425-0414 | Advanced Rx of Tennessee, LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80425-0414-3) | July 11, 2024 |
| 76420-598-07 | 76420-598 | Asclemed USA, Inc. | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-07) | September 2, 2023 |
| 76420-598-10 | 76420-598 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-10) | September 2, 2023 |
| 76420-598-14 | 76420-598 | Asclemed USA, Inc. | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-14) | September 2, 2023 |
| 76420-598-20 | 76420-598 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-20) | September 2, 2023 |
| 76420-598-30 | 76420-598 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-30) | September 2, 2023 |
| 76420-598-60 | 76420-598 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-60) | September 2, 2023 |
| 76420-598-90 | 76420-598 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (76420-598-90) | September 2, 2023 |
| 68001-612-00 | 68001-612 | BluePoint Laboratories | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68001-612-00) | February 12, 2024 |
| 71335-9665-0 | 71335-9665 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-0) | April 13, 2026 |
| 71335-9665-1 | 71335-9665 | Bryant Ranch Prepack | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-1) | March 22, 2023 |
| 71335-9665-2 | 71335-9665 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-2) | March 23, 2023 |
| 71335-9665-3 | 71335-9665 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-3) | April 13, 2026 |
| 71335-9665-4 | 71335-9665 | Bryant Ranch Prepack | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-4) | March 20, 2023 |
| 71335-9665-5 | 71335-9665 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-5) | September 24, 2024 |
| 71335-9665-6 | 71335-9665 | Bryant Ranch Prepack | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-6) | January 24, 2024 |
| 71335-9665-7 | 71335-9665 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-7) | April 13, 2026 |
| 71335-9665-8 | 71335-9665 | Bryant Ranch Prepack | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-8) | April 13, 2026 |
| 71335-9665-9 | 71335-9665 | Bryant Ranch Prepack | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-9665-9) | April 13, 2026 |
| 50742-278-01 | 50742-278 | Ingenus Pharmaceuticals, LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50742-278-01) | September 26, 2022 |
| 70518-4044-0 | 70518-4044 | REMEDYREPACK INC. | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-0) | April 5, 2024 |
| 70518-4044-1 | 70518-4044 | REMEDYREPACK INC. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4044-1) | June 13, 2025 |
| 85766-032-01 | 85766-032 | Sportpharm LLC | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-01) | August 7, 2025 |
| 85766-032-07 | 85766-032 | Sportpharm LLC | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-07) | August 7, 2025 |
| 85766-032-14 | 85766-032 | Sportpharm LLC | 14 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-14) | August 7, 2025 |
| 85766-032-20 | 85766-032 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-20) | August 7, 2025 |
| 85766-032-30 | 85766-032 | Sportpharm LLC | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-30) | August 7, 2025 |
| 85766-032-60 | 85766-032 | Sportpharm LLC | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-60) | August 7, 2025 |
| 85766-032-90 | 85766-032 | Sportpharm LLC | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (85766-032-90) | August 7, 2025 |
| 80425-0414 | 80425-0414 | Advanced Rx of Tennessee, LLC | — | July 11, 2024 |
| 76420-598 | 76420-598 | Asclemed USA, Inc. | — | September 26, 2022 |
| 68001-612 | 68001-612 | BluePoint Laboratories | — | February 12, 2024 |
| 71335-9665 | 71335-9665 | Bryant Ranch Prepack | — | September 26, 2022 |
| 50742-278 | 50742-278 | Ingenus Pharmaceuticals, LLC | — | September 26, 2022 |
| 70518-4044 | 70518-4044 | REMEDYREPACK INC. | — | April 5, 2024 |
| 85766-032 | 85766-032 | Sportpharm LLC | — | September 26, 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.