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Etodolac
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Anti-Inflammatory Agents | EPC | All 251 members |
| Cyclooxygenase Inhibitors [MoA] | MoA | All 251 members |
| Non-Steroidal [CS] | CS | All 251 members |
| Nonsteroidal Anti-inflammatory Drug [EPC] | EPC | All 251 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 076174-001 | ETODOLAC | TABLET, EXTENDED RELEASE | ETODOLAC | Prescription | AB | ||
| 076174-002 | ETODOLAC | TABLET, EXTENDED RELEASE | ETODOLAC | Prescription | AB | ||
| 076174-003 | ETODOLAC | TABLET, EXTENDED RELEASE | ETODOLAC | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 20 | Labeling | Approved | November 21, 2024 | Standard |
| Supplement | 14 | Labeling | Approved | April 28, 2021 | Standard |
| Supplement | 10 | Labeling | Approved | May 9, 2016 | Standard |
| Supplement | 5 | Labeling | Approved | March 8, 2006 | — |
| Original application | 1 | Approved | March 13, 2003 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260714). 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). Etodolac extended-release tablets, 400 mg, 500 mg and 600 mg are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see CONTRAINDICATIONS and WARNINGS). Gastrointestinal Risk NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. (See WARNINGS).
Indications and Usage
openFDA Drug LabelingIndications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac extended-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS). Etodolac extended-release tablets are indicated: * For relief of signs and symptoms of juvenile arthritis * For relief of the signs and symptoms of rheumatoid arthritis * For relief of the signs and symptoms of osteoarthritis
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of etodolac extended-release tablets and other treatment options before deciding to use etodolac 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 etodolac extended-release tablets, the dose and frequency should be adjusted to suit an individual patient's needs. Juvenile Rheumatoid Arthritis For the relief of the signs and symptoms of juvenile rheumatoid arthritis in patients 6 to 16 years of age, the recommended dose given orally once per day should be based on body weight, according to the following table: Table 4. Body Weight Range (kg) Dose 20 to 30 400 mg Tablet × 1 31 to 45 600 mg Tablet × 1 46 to 60 400 mg Tablet × 2 >60 500 mg Tablet × 2 Rheumatoid Arthritis and Osteoarthritis For the relief of the signs and symptoms of osteoarthritis or rheumatoid arthritis, the recommended starting dose of etodolac extended-release tablets is 400 to 1000 mg given orally once per day. As with other NSAIDs, the lowest effective dose should be sought for each patient. In chronic conditions, a therapeutic response to therapy with etodolac extended-release tablets is sometimes seen within one week of therapy, but most often is observed by two weeks.
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Etodolac extended-release tablets are contraindicated in patients with known hypersensitivity to etodolac. Etodolac extended-release 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, Anaphylactoid Reactions and PRECAUTIONS, Preexisting Asthma ). Etodolac extended-release 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 etodolac, 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 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 etodolac extended-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac extended-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs, including etodolac extended-release 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 etodolac 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. 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 ri …
Warnings
openFDA Drug LabelingWARNINGS Cardiovascular Effects Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur. There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as etodolac, increases the risk of serious gastrointestinal (GI) events (see WARNINGS ). 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 etodolac extended-release tablets in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If etodolac extended-release tablets are used in patients with a recent MI, monitor patients for signs of cardiac ischemia. Hypertension NSAIDs, including etodolac extended-release 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 etodolac 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. 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, hosp …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS A total of 1552 patients were exposed to etodolac extended-release tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment with etodolac extended-release tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy. In patients taking NSAIDs, including etodolac extended-release tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: gastrointestinal experiences including: abdominal pain constipation diarrhea dyspepsia flatulence GI ulcers (gastric/duodenal) Adverse events that were observed in < 1% of patients in the first 30 days of treatment with etodolac extended-release tablets in clinical trials. gross bleeding/perforation nausea vomiting other events including: abnormal renal function anemia asthenia dizziness edema elevated liver enzymes headaches hypertension increased bleeding time infection pharyngitis pruritus rashes rhinitis tinnitus Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Etodolac Extended-Release Tablets Include Body as a whole - allergic reaction, anaphylactic/anaphylactoid reactions (including shock), chills, fever, sepsis Cardiovascular system - congestive heart failure, flushing, palpitations, tachycardia, syncope, vasculitis (including necrotizing and allergic) Digestive system - anorexia, cholestatic hepatitis, cholestatic jaundice, dry mouth, duodenitis, eructation, esophagitis, gastritis, gastric/peptic ulcers, glossitis, hepatic failure, hepatitis, hematemesis, intestinal ulceration, jaundice, liver necrosis, melena, pancreatitis, rectal bleeding, stomatitis Hemic and lymphatic system - agranulocytosis, ecchymosis, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, purpura, thrombocytopenia Metabolic and nutritional - hyperglycemia in previously controlled diabetic patients Nervous system - anxiety, confusion, depression, dream abnormalities, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo Respiratory system - asthma, dyspnea, pulmonary infiltration with eosinophilia Skin and appendages - angioedema, cutaneous vasculitis with purpura, erythema multiforme, hyperpigmentation, sweating, urticaria, vesiculobullous rash Special senses - blurred vision, photophobia, transient visual disturbances Urogenital system - dysuria, elevated BUN, oliguria/polyuria, proteinuria, renal failure, renal insufficiency, renal papillary necrosis, serum creatinine increase, urinary frequency Other NSAID Adverse Reactions, Which Occur Rarely Are Body as a whole - anaphylactic reactions, appetite changes, death Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction Digestive system - colitis, esophagitis with or without stricture or cardiospasm, thirst, ulcerative stomatitis Hemic and lymphatic system - aplastic anemia, lymphadenopathy Metabolic and nutritional - change in weight Nervous system - coma, convulsions, hallucinations, meningitis Respiratory - bronchitis, pneumonia, respiratory depression, sinusitis Skin and appendages - alopecia, exfoliative dermatitis, maculopapular rash, photosensitivity, skin peeling, Stevens-Johnson syndrome, toxic epidermal necrosis (TEN), and fixed drug eruption (FDE) (see WARNINGS) Special senses - conjunctivitis, deafness, hearing impairment, taste perversion Urogenital system - cystitis, hematuria, interstitial nephritis, leukorrhea, renal calculus, uterine bleeding irregularities
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 etodolac extended-release tablets are administered with aspirin, its protein binding is reduced, although the clearance of free etodolac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of etodolac extended-release tablets and aspirin is not generally recommended because of the potential of increased adverse effects. Cyclosporine and Digoxin Etodolac extended-release tablets, like other NSAIDs, through effects on renal prostaglandins, may cause changes in the elimination of these drugs, leading to elevated serum levels of cyclosporine and digoxin and increased toxicity. Nephrotoxicity associated with cyclosporine may also be enhanced. Patients receiving these drugs who are given etodolac extended-release tablets, or any other NSAID, and particularly those patients with altered renal function, should be observed for the development of the specific toxicities of these drugs. Furosemide Clinical studies, as well as post marketing observations, have shown that etodolac extended-release tablets 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, Renal Effects ), 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. Phenylbutazone Phenylbutazone causes an increase (by about 80%) in the free fraction of etodolac. Although in vivo studies have not been done to see if etodolac clearance is changed by coadministration of phenylbutazone, it is not recommended that they be coadministered. 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.
Description
openFDA Drug LabelingDESCRIPTION Etodolac Extended-Release Tablets contain etodolac, which is a member of the pyranocarboxylic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Each tablet contains etodolac for oral administration. Etodolac is a racemic mixture of [+]S and [-]R-enantiomers. It is a white crystalline compound, insoluble in water, but soluble in alcohols, chloroform, dimethyl sulfoxide, and aqueous polyethylene glycol. The chemical name is (±) 1,8-diethyl-1,3,4,9-tetrahydropyrano-[3,4-b]indole-1-acetic acid. The molecular weight is 287.37. Its molecular formula is C 17 H 21 NO 3 and it has the following structural formula: The inactive ingredients in etodolac extended-release tablets include: HPMC 2910, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, PEG 8000, polydextrose FCC, povidone, titanium dioxide and triacetin. In addition, the 500 mg and 600 mg tablets contain Indigo Carmine Lake and the 400 mg and 600 mg tablets contain Allura Red AC Lake and Sunset Yellow F.C.F. Lake. In addition, the 500 mg tablets contain yellow iron oxide. Meets USP Dissolution Test 4. Chemical Structure
Overdosage
openFDA Drug LabelingOverdosage Symptoms following acute NSAID overdose are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. 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 an NSAID overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose (5 to 10 times the usual dose). Forced diuresis, alkalinization of the urine, hemodialysis, or hemoperfusion may not be useful due to high protein binding.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Etodolac extended-release tablets are available as: 400 mg tablets (pink, round, bi-convex, film coated tablet engraved with "T400" on one side and plain on the other side). in bottles of 30, NDC 51672-4051-6 in bottles of 60, NDC 51672-4051-4 in bottles of 100, NDC 51672-4051-1 in bottles of 500, NDC 51672-4051-2 in bottles of 1000, NDC 51672-4051-3 in unit dose packages of 60, NDC 51672-4051-9 500 mg tablets (green, oblong, normal convex, film coated tablet engraved with "T500" on one side and plain on the other side). in bottles of 30, NDC 51672-4052-6 in bottles of 60, NDC 51672-4052-4 in bottles of 100, NDC 51672-4052-1 in bottles of 500, NDC 51672-4052-2 in bottles of 1000, NDC 51672-4052-3 in unit dose packages of 60, NDC 51672-4052-9 600 mg tablets (grey, oval, bi-convex, film coated tablet engraved with "T600" on one side and plain on the other side). in bottles of 30, NDC 51672-4053-6 in bottles of 60, NDC 51672-4053-4 in bottles of 100, NDC 51672-4053-1 in bottles of 500, NDC 51672-4053-2 in bottles of 1000, NDC 51672-4053-3 in unit dose packages of 60, NDC 51672-4053-9 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from excessive heat and humidity. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ETODOLAC. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 80425-0126-1 | 80425-0126 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0126-1) | March 13, 2003 |
| 80425-0181-1 | 80425-0181 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0181-1) | March 13, 2003 |
| 60429-313-01 | 60429-313 | Golden State Medical Supply, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-313-01) | July 18, 2011 |
| 60429-314-01 | 60429-314 | Golden State Medical Supply, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60429-314-01) | July 18, 2011 |
| 16714-497-01 | 16714-497 | NORTHSTAR RX LLC | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-01) | August 15, 2016 |
| 16714-497-02 | 16714-497 | NORTHSTAR RX LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-497-02) | August 15, 2016 |
| 16714-498-02 | 16714-498 | NORTHSTAR RX LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-498-02) | August 15, 2016 |
| 16714-499-01 | 16714-499 | NORTHSTAR RX LLC | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-499-01) | August 15, 2016 |
| 16714-499-02 | 16714-499 | NORTHSTAR RX LLC | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (16714-499-02) | August 15, 2016 |
| 63187-793-20 | 63187-793 | Proficient Rx LP | 20 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-20) | December 1, 2016 |
| 63187-793-30 | 63187-793 | Proficient Rx LP | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-30) | December 1, 2016 |
| 63187-793-60 | 63187-793 | Proficient Rx LP | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-60) | December 1, 2016 |
| 63187-793-90 | 63187-793 | Proficient Rx LP | 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (63187-793-90) | December 1, 2016 |
| 51672-4051-1 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-1) | March 13, 2003 |
| 51672-4051-2 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-2) | March 13, 2003 |
| 51672-4051-3 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-3) | March 13, 2003 |
| 51672-4051-4 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-4) | March 13, 2003 |
| 51672-4051-6 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4051-6) | March 13, 2003 |
| 51672-4051-9 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | 10 BLISTER PACK in 1 CARTON (51672-4051-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 13, 2003 |
| 51672-4052-1 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4052-1) | March 13, 2003 |
| 51672-4052-2 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4052-2) | March 13, 2003 |
| 51672-4052-3 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4052-3) | March 13, 2003 |
| 51672-4052-4 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4052-4) | March 13, 2003 |
| 51672-4052-6 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4052-6) | March 13, 2003 |
| 51672-4052-9 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | 10 BLISTER PACK in 1 CARTON (51672-4052-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 13, 2003 |
| 51672-4053-1 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-1) | March 13, 2003 |
| 51672-4053-2 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-2) | March 13, 2003 |
| 51672-4053-3 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-3) | March 13, 2003 |
| 51672-4053-4 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-4) | March 13, 2003 |
| 51672-4053-6 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (51672-4053-6) | March 13, 2003 |
| 51672-4053-9 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | 10 BLISTER PACK in 1 CARTON (51672-4053-9) / 6 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | March 13, 2003 |
| 80425-0126 | 80425-0126 | Advanced Rx Pharmacy of Tennessee, LLC | — | March 13, 2003 |
| 80425-0181 | 80425-0181 | Advanced Rx Pharmacy of Tennessee, LLC | — | March 13, 2003 |
| 60429-313 | 60429-313 | Golden State Medical Supply, Inc. | — | March 13, 2003 |
| 60429-314 | 60429-314 | Golden State Medical Supply, Inc. | — | March 13, 2003 |
| 16714-497 | 16714-497 | NORTHSTAR RX LLC | — | March 13, 2003 |
| 16714-498 | 16714-498 | NORTHSTAR RX LLC | — | March 13, 2003 |
| 16714-499 | 16714-499 | NORTHSTAR RX LLC | — | March 13, 2003 |
| 63187-793 | 63187-793 | Proficient Rx LP | — | March 13, 2003 |
| 51672-4051 | 51672-4051 | TaSun Pharmaceutical Industries, Inc. | — | March 13, 2003 |
| 51672-4052 | 51672-4052 | TaSun Pharmaceutical Industries, Inc. | — | March 13, 2003 |
| 51672-4053 | 51672-4053 | TaSun Pharmaceutical Industries, Inc. | — | March 13, 2003 |
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.