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Ketorolac Tromethamine
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Ketorolac Tromethamine | 10 mg/1 | 1665461 | 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 Inhibitor [EPC] | EPC | 7 members — no class page |
| 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 |
|---|---|---|---|---|---|---|---|
| 215788-001 | KETOROLAC TROMETHAMINE | TABLET | KETOROLAC TROMETHAMINE | 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 | 5 | Labeling | Approved | November 21, 2024 | Standard |
| Original application | 1 | Approved | March 23, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260817). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING Ketorolac tromethamine tablets, a non-steroidal anti-inflammatory drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary. The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days. Ketorolac tromethamine tablets are not indicated for use in pediatric patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse events. GASTROINTESTINAL RISK • Ketorolac tromethamine, including ketorolac tromethamine tablets can cause peptic ulcers, gastrointestinal bleeding and/or perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation, and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS ). CARDIOVASCULAR RISK • NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS and CLINICAL STUDIES ). • Ketorolac tromethamine is CONTRAINDICATED for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). RENAL RISK • Ketorolac tromethamine is CONTRAINDICATED in patients with advanced renal impairment and in patients at risk for renal failure due to volume depletion (see WARNINGS ). RISK OF BLEEDING • Ketorolac tromethamine inhibits platelet function and is, therefore, CONTRAINDICATED in patients with suspected or confirmed cerebrovascular bleeding, patients with hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ). Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic before any major surgery. RISK DURING LABOR AND DELIVERY • The use of ketorolac tromethamine in labor and delivery is contraindicated because it may adversely affect fetal circulation and inhibit uterine contractions. CONCOMITANT USE WITH NSAIDs • Ketorolac tromethamine is CONTRAINDICATED in patients currently receiving aspirin or NSAIDs because of the cumulative risk of inducing serious NSAID-related side effects. SPECIAL POPULATIONS • Dosage should be adjusted for patients 65 years or older, for patients under 50 kg (110 lbs) of body weight (see DOSAGE AND ADMINISTRATION ) and for patients with moderately elevated serum creatinine (see WARNINGS ).
Indications and Usage
openFDA Drug LabelingIndications and Usage Section INDICATIONS AND USAGE Carefully consider the potential benefits and risks of Ketorolac Tromethamine Tablets USP and other treatment options before deciding to use Ketorolac Tromethamine Tablets USP. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. Acute Pain in Adult Patients Ketorolac Tromethamine Tablets USP are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. Therapy should always be initiated with IV or IM dosing of ketorolac tromethamine and Ketorolac Tromethamine Tablets USP are to be used only as continuation treatment, if necessary. The total combined duration of use of Ketorolac Tromethamine Tablets USP and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see WARNINGS, PRECAUTIONS, DOSAGE AND ADMINISTRATION, and ADVERSE REACTIONS). Patients should be switched to alternative analgesics as soon as possible, but Ketorolac Tromethamine Tablet USP therapy is not to exceed 5 days.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Carefully consider the potential benefits and risks of ketorolac tromethamine tablets and other treatment options before deciding to use ketorolac tromethamine tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. In adults, the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. In adults, the use of ketorolac tromethamine tablets is only indicated as continuation therapy to intravenous or intramuscular dosing of ketorolac tromethamine. Transition from intravenous or intramuscular dosing of ketorolac tromethamine (single- or multiple-dose) to multiple-dose ketorolac tromethamine tablets: Patients age 17 to 64: 20 mg PO once followed by 10 mg q4 hours to 6 hours prn not > 40 mg/day Patients age ≥ 65, renally impaired, and/or weight 40 mg/day Note: Oral formulation should not be given as an initial dose Use minimum effective dose for the individual patient Do not shorten dosing interval of 4 hours to 6 hours Total duration of treatment in adult patients: the combined duration of use of intravenous or intramuscular dosing of ketorolac tromethamine and ketorolac tromethamine tablets is not to exceed 5 days. The following table summarizes ketorolac tromethamine tablets dosing instructions in terms of age group: Table 4: Summary of Dosing Instructions Patient Population Ketorolac Tromethamine Tablets (Following Intravenous or Intramuscular dosing of ketorolac tromethamine) Age 40 mg/day Adult Age ≥ 65 years, renally impaired, and/or weight 40 mg/day
Dosage Forms and Strengths
openFDA Drug LabelingDosage Form and Strength Each Film-Coated tablet Contains Ketorolac Tromethamine, USP 10MG
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS (see also Boxed WARNING ) Ketorolac tromethamine tablets are contraindicated in patients with previously demonstrated hypersensitivity to ketorolac tromethamine. Ketorolac tromethamine tablets are contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding. Ketorolac tromethamine 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 ). Ketorolac tromethamine tablets are contraindicated as prophylactic analgesic before any major surgery. Ketorolac tromethamine tablets are contraindicated in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS ). Ketorolac tromethamine tablets are contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion (see WARNINGS for correction of volume depletion). Ketorolac tromethamine tablets are contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage. Ketorolac tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding (see WARNINGS and PRECAUTIONS ). Ketorolac tromethamine tablets are contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events. The concomitant use of ketorolac tromethamine and probenecid is contraindicated. The concomitant use of ketorolac tromethamine and pentoxifylline is contraindicated.
Warnings and Cautions
openFDA Drug LabelingPRECAUTIONS General Ketorolac tromethamine cannot be expected to substitute for corticosteroids or to treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to disease exacerbation. Patients on prolonged corticosteroid therapy should have their therapy tapered slowly if a decision is made to discontinue corticosteroids. The pharmacological activity of ketorolac tromethamine in reducing inflammation may diminish the utility of this diagnostic sign in detecting complications of presumed noninfectious, painful conditions. Hepatic Effect Ketorolac tromethamine should be used with caution in patients with impaired hepatic function or a history of liver disease. Borderline elevations of one or more liver tests may occur in up to 15% of patients taking NSAIDs including ketorolac tromethamine. These laboratory abnormalities may progress, may remain unchanged, or may be transient with continuing therapy. Notable elevations of ALT or AST (approximately three or more times the upper limit of normal) have been reported in approximately 1% of patients in clinical trials with NSAIDs. In addition, rare cases of severe hepatic reactions, including jaundice and fatal fulminant hepatitis, liver necrosis and hepatic failure, some of them with fatal outcomes have been reported. A patient with symptoms and/or signs suggesting liver dysfunction, or in whom an abnormal liver test has occurred, should be evaluated for evidence of the development of a more severe hepatic reaction while on therapy with ketorolac tromethamine. If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), ketorolac tromethamine should be discontinued. Hematologic Effect Anemia is sometimes seen in patients receiving NSAIDs, including ketorolac tromethamine. This may be due to fluid retention, occult or gross GI blood loss, or an incompletely described effect upon erythropoiesis. Patients on long-term treatment with NSAIDs, including ketorolac tromethamine, should have their hemoglobin or hematocrit checked if they exhibit any signs or symptoms of anemia. NSAIDs inhibit platelet aggregation and have been shown to prolong bleeding time in some patients. Unlike aspirin, their effect on platelet function is quantitatively less, of shorter duration, and reversible. Patients receiving ketorolac tromethamine who may be adversely affected by alterations in platelet function, such as those with coagulation disorders or patients receiving anticoagulants, should be carefully monitored. Preexisting Asthma Patients with asthma may have aspirin-sensitive asthma. The use of aspirin in patients with aspirin-sensitive asthma has been associated with severe bronchospasm which can be fatal. Since cross reactivity, including bronchospasm, between aspirin and other nonsteroidal anti-inflammatory drugs has been reported in such aspirin-sensitive patients, ketorolac tromethamine should not be administered to patients with this form of aspirin sensitivity and should be used with caution in patients with preexisting asthma. Information for Patients Ketorolac tromethamine is a potent NSAID and may cause serious side effects such as gastrointestinal bleeding or kidney failure, which may result in hospitalization and even fatal outcome. Physicians, when prescribing ketorolac tromethamine, should inform their patients or their guardians of the potential risks of ketorolac tromethamine treatment (see Boxed WARNING, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections), instruct patients to seek medical advice if they develop treatment-related adverse events, and advise patients not to give ketorolac tromethamine tablets to other family members and to discard any unused drug. Remember that the total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use …
Warnings
openFDA Drug LabelingWARNINGS (See also Boxed WARNING ) The total combined duration of use of ketorolac tromethamine tablets and IV or IM dosing of ketorolac tromethamine is not to exceed 5 days in adults. Ketorolac tromethamine tablets are not indicated for use in pediatric patients. The most serious risks associated with ketorolac tromethamine are: Gastrointestinal Effects – Risk of Ulceration, Bleeding, and Perforation Ketorolac tromethamine is contraindicated in patients with previously documented peptic ulcers and/or GI bleeding. Ketorolac tromethamine can cause serious gastrointestinal (GI) adverse events including 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 ketorolac tromethamine. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Minor upper gastrointestinal problems, such as dyspepsia, are common and may also occur at any time during NSAID therapy. The incidence and severity of gastrointestinal complications increases with increasing dose of, and duration of treatment with, ketorolac tromethamine. Do not use ketorolac tromethamine for more than five days. However, even short-term therapy is not without risk. In addition to past history of ulcer disease, 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, the lowest effective dose should be used for the shortest possible duration. Patients and physicians should remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy and promptly initiate additional evaluation and treatment if a serious GI adverse event is suspected. This should include discontinuation of ketorolac tromethamine until a serious GI adverse event is ruled out. For high risk patients, alternate therapies that do not involve NSAIDs should be considered. NSAIDs should be given with care to patients with a history of inflammatory bowel disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated. Hemorrhage Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet aggregation as well, use of ketorolac tromethamine in patients who have coagulation disorders should be undertaken very cautiously, and those patients should be carefully monitored. Patients on therapeutic doses of anticoagulants (e.g., heparin or dicumarol derivatives) have an increased risk of bleeding complications if given ketorolac tromethamine concurrently, therefore, physicians should administer such concomitant therapy only extremely cautiously. The concurrent use of ketorolac tromethamine and therapy that affects hemostasis, including prophylactic low-dose heparin (2500 to 5000 units q12h), warfarin and dextrans have not been studied extensively, but may also be associated with an increased risk of bleeding. Until data from such studies are available, physicians should carefully weigh the benefits against the risks and use such concomitant therapy in these patients only extremely cautiously. Patients receiving therapy that affects hemostasis should be monitored closely. In postmarketing experience, postoperative hematomas and other signs of wound bleeding have been reported in association with the peri-operative use of IV or IM dosing of ketorolac tromethamine. Therefore, peri-operative use of ketorolac tromethamine should be avoided and postoperative use be undertaken with caution when hemostasis is critical (see PRECAUTIONS ). Renal Effects Long …
Adverse Reactions
openFDA Drug LabelingAdverse Reactions Adverse reaction rates increase with higher doses of ketorolac tromethamine. Practitioners should be alert for the severe complications of treatment with ketorolac tromethamine, such as GI ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure (see Boxed WARNING, WARNINGS, PRECAUTIONS, and DOSAGE AND ADMINISTRATION). These NSAID-related complications can be serious in certain patients for whom ketorolac tromethamine is indicated, especially when the drug is used inappropriately. In patients taking ketorolac tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are: Additional adverse experiences reported occasionally (< 1% in patients taking ketorolac tromethamine or other NSAIDs in clinical trials) include: Body as a Whole: fever, infections, sepsis Cardiovascular : congestive heart failure, palpitation, pallor, tachycardia, syncope Dermatologic : alopecia, photosensitivity, urticaria Gastrointestinal : anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding Hemic and Lymphatic : ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia Metabolic and Nutritional: weight change Nervous System : abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise Reproductive, female : infertility Respiratory : asthma, cough, dyspnea, pulmonary edema, rhinitis Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss Urogenital : cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention Other rarely observed reactions (reported from postmarketing experience in patients taking ketorolac tromethamine or other NSAIDs) are: Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema (see WARNINGS), myalgia Cardiovascular : arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis Dermatologic : exfoliative dermatitis, erythema multiforme, Lyell’s syndrome, bullous reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, and fixed drug eruption (FDE) Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease (ulcerative colitis, Crohn's disease) Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, postoperative wound hemorrhage (rarely requiring blood transfusion - see Boxed WARNING,WARNINGS, and PRECAUTIONS) Metabolic and Nutritional : hyperglycemia, hyperkalemia, hyponatremia Nervous System : aseptic meningitis, convulsions, coma, psychosis Respiratory : bronchospasm, respiratory depression, pneumonia Special Senses : conjunctivitis Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome Postmarketing Surveillance Study A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving ketorolac tromethamine IV/IM, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent (see Tables 3A and 3B). This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of ketorolac tromethamine IV/IM (see Table 3A). To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-BION or 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Table 3
Drug Interactions
openFDA Drug LabelingDrug Interactions Ketorolac is highly bound to human plasma protein (mean 99.2%). There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs. Warfarin, Digoxin, Salicylate, and Heparin The in vitro binding of warfarin to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs 99.3%) when ketorolac plasma concentrations reach 5 to 10 mcg/mL. Ketorolac does not alter digoxin protein binding. In vitro studies indicate that, at therapeutic concentrations of salicylate (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential twofold increase in unbound ketorolac plasma levels. Therapeutic concentrations of digoxin, warfarin, ibuprofen, naproxen, piroxicam, acetaminophen, phenytoin and tolbutamide did not alter ketorolac tromethamine protein binding. In a study involving 12 adult volunteers, ketorolac tromethamine tablets were coadministered with a single dose of 25 mg warfarin , causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, ketorolac tromethamine dosed IV or IM was given with two doses of 5000 U of heparin to 11 healthy volunteers, resulting in a mean template bleeding time of 6.4 minutes (3.2 to 11.4 min) compared to a mean of 6 minutes (3.4 to 7.5 min) for heparin alone and 5.1 minutes (3.5 to 8.5 min) for placebo. Although these results do not indicate a significant interaction between ketorolac tromethamine and warfarin or heparin, the administration of ketorolac tromethamine to patients taking anticoagulants should be done extremely cautiously, and patients should be closely monitored (see WARNINGS and PRECAUTIONS , Hematologic Effect ). The effects of warfarin and NSAIDs, in general, on GI bleeding are synergistic, such that the users of both drugs together have a risk of serious GI bleeding higher than the users of either drug alone. Aspirin When ketorolac tromethamine is administered with aspirin, its protein binding is reduced, although the clearance of free ketorolac tromethamine is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of ketorolac tromethamine and aspirin is not generally recommended because of the potential of increased adverse effects. Diuretics Clinical studies, as well as postmarketing observations, have shown that ketorolac tromethamine 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. Probenecid Concomitant administration of ketorolac tromethamine tablets and probenecid resulted in decreased clearance and volume of distribution of ketorolac and significant increases in ketorolac plasma levels (total AUC increased approximately threefold from 5.4 to 17.8 mcg/h/mL) and terminal half-life increased approximately twofold from 6.6 to 15.1 hours. Therefore, concomitant use of ketorolac tromethamine and probenecid is contraindicated. 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 c …
Description
openFDA Drug LabelingDESCRIPTION Ketorolac tromethamine, USP is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs). The chemical name for ketorolac tromethamine, USP is (±)-5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and the chemical structure is: Ketorolac tromethamine, USP is a racemic mixture of [-]S and [+]R ketorolac tromethamine. Ketorolac tromethamine, USP is white to off white, crystalline powder. Freely soluble in water and methanol, slightly soluble in alcohol, dehydrated alcohol and tetrahydrofuran, practically insoluble in acetone, dichloromethane, toluene, ethyl acetate, dioxane, hexane, butyl alcohol and acetonitrile. Ketorolac tromethamine, USP has a pKa of 3.5 and an n‐octanol/water partition coefficient of 0.26. The molecular weight of ketorolac tromethamine is 376.40 g/mol. Its molecular formula is C 15 H 13 NO 3 •C 4 H 11 NO 3. Ketorolac tromethamine tablets, USP are available as round, white, unscored, film-coated tablets. Each film-coated tablet, for oral administration, contains 10 mg ketorolac tromethamine, USP, the active ingredient, with added colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose. The white film-coating contains hypromellose, polydextrose, polyethylene glycol, sodium lauryl sulfate, titanium dioxide, and triacetin. FDA approved dissolution test specifications differ from USP. ketorolac tromethamine structural formula
Overdosage
openFDA Drug LabelingOVERDOSAGE Symptoms and Signs Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose. Treatment Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg 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 oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.
Symptoms and Signs Symptoms following acute NSAID overdoses are usually limited to lethargy, drowsiness, nausea, vomiting, and epigastric pain, which are generally reversible with supportive care. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs and may occur following an overdose.
Treatment Patients should be managed by symptomatic and supportive care following a NSAIDs overdose. There are no specific antidotes. Emesis and/or activated charcoal (60 g to 100 g in adults, 1 g/kg 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 oral overdose (5 to 10 times the usual dose). Forced diuresis, alkalization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding. Single overdoses of ketorolac tromethamine have been variously associated with abdominal pain, nausea, vomiting, hyperventilation, peptic ulcers and/or erosive gastritis and renal dysfunction which have resolved after discontinuation of dosing.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Ketorolac tromethamine tablets, USP are available as follows: 10 mg: White, round, convex, film-coated tablets, debossed "93" on one side and "314" on the other side. They are available as below Bottles of 1 tablets NDC 85766-035-00 (repackaged from NDC 0093-0314-XX) Bottles of 2 tablets NDC 85766-035-02 (repackaged from NDC 0093-0314-XX) Bottles of 6 tablets NDC 85766-035-06 (repackaged from NDC 0093-0314-XX) Bottles of 10 tablets NDC 85766-035-10 (repackaged from NDC 0093-0314-XX) Bottles of 14 tablets NDC 85766-035-14 (repackaged from NDC 0093-0314-XX) Bottles of 20 tablets NDC 85766-035-20 (repackaged from NDC 0093-0314-XX) Bottles of 30 tablets NDC 85766-035-30 (repackaged from NDC 0093-0314-XX) Bottles of 60 tablets NDC 85766-035-60 (repackaged from NDC 0093-0314-XX) Bottles of 90 tablets NDC 85766-035-90 (repackaged from NDC 0093-0314-XX) Bottles of 100 tablets NDC 85766-035-01 (relabeled from NDC 0093-0314-01) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Protect from light and excessive humidity. Keep this and all medications out of the reach of children. Dispense with Medication Guide available at: www.tevausa.com/medguides Distributed by: Sportpharm LLC 379 Van Ness Ave 1401, Torrance, CA 90501 Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: KETOROLAC TROMETHAMINE. 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 |
|---|---|---|---|---|
| 50090-0601-0 | 50090-0601 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-0601-0) | November 28, 2014 |
| 50090-0601-3 | 50090-0601 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-0601-3) | November 28, 2014 |
| 50090-7265-0 | 50090-7265 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7265-0) | October 7, 2024 |
| 50090-7265-3 | 50090-7265 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7265-3) | October 7, 2024 |
| 50090-7453-0 | 50090-7453 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7453-0) | November 13, 2024 |
| 50090-7453-3 | 50090-7453 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7453-3) | November 13, 2024 |
| 50090-7638-0 | 50090-7638 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7638-0) | August 25, 2025 |
| 50090-7638-3 | 50090-7638 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7638-3) | August 25, 2025 |
| 50090-7695-0 | 50090-7695 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7695-0) | October 10, 2025 |
| 50090-7695-3 | 50090-7695 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7695-3) | October 10, 2025 |
| 50090-7808-0 | 50090-7808 | A-S Medication Solutions | 20 TABLET, FILM COATED in 1 BOTTLE (50090-7808-0) | December 2, 2025 |
| 50090-7808-3 | 50090-7808 | A-S Medication Solutions | 10 TABLET, FILM COATED in 1 BOTTLE (50090-7808-3) | December 2, 2025 |
| 80425-0139-1 | 80425-0139 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0139-1) | June 17, 1998 |
| 80425-0139-2 | 80425-0139 | Advanced Rx Pharmacy of Tennessee, LLC | 9 TABLET, FILM COATED in 1 BOTTLE (80425-0139-2) | June 17, 1998 |
| 80425-0139-3 | 80425-0139 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0139-3) | June 17, 1998 |
| 80425-0267-1 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | 9 TABLET, FILM COATED in 1 BOTTLE (80425-0267-1) | February 17, 2023 |
| 80425-0267-2 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0267-2) | February 17, 2023 |
| 80425-0267-3 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0267-3) | February 17, 2023 |
| 80425-0267-4 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0267-4) | February 17, 2023 |
| 80425-0267-5 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | 10 TABLET, FILM COATED in 1 BOTTLE (80425-0267-5) | March 30, 2023 |
| 80425-0489-1 | 80425-0489 | Advanced Rx of Tennessee, LLC | 9 TABLET, FILM COATED in 1 BOTTLE (80425-0489-1) | January 30, 2025 |
| 80425-0489-2 | 80425-0489 | Advanced Rx of Tennessee, LLC | 10 TABLET, FILM COATED in 1 BOTTLE (80425-0489-2) | January 30, 2025 |
| 80425-0489-3 | 80425-0489 | Advanced Rx of Tennessee, LLC | 20 TABLET, FILM COATED in 1 BOTTLE (80425-0489-3) | January 30, 2025 |
| 80425-0489-4 | 80425-0489 | Advanced Rx of Tennessee, LLC | 30 TABLET, FILM COATED in 1 BOTTLE (80425-0489-4) | January 30, 2025 |
| 80425-0489-5 | 80425-0489 | Advanced Rx of Tennessee, LLC | 60 TABLET, FILM COATED in 1 BOTTLE (80425-0489-5) | January 30, 2025 |
| 27241-316-01 | 27241-316 | Ajanta Pharma USA Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (27241-316-01) | January 18, 2025 |
| 60687-104-21 | 60687-104 | American Health Packaging | 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-104-21) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-104-11) | March 23, 2021 |
| 87564-018-10 | 87564-018 | Amerisyn LLC | 100 TABLET, FILM COATED in 1 BOTTLE (87564-018-10) | July 26, 2026 |
| 69292-650-01 | 69292-650 | Amici Pharma Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (69292-650-01) | December 22, 2025 |
| 76420-032-01 | 76420-032 | Asclemed USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (76420-032-01) | September 16, 2022 |
| 76420-032-02 | 76420-032 | Asclemed USA, Inc. | 2 TABLET, FILM COATED in 1 BOTTLE (76420-032-02) | November 10, 2020 |
| 76420-032-04 | 76420-032 | Asclemed USA, Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (76420-032-04) | November 10, 2020 |
| 76420-032-07 | 76420-032 | Asclemed USA, Inc. | 7 TABLET, FILM COATED in 1 BOTTLE (76420-032-07) | September 6, 2023 |
| 76420-032-10 | 76420-032 | Asclemed USA, Inc. | 10 TABLET, FILM COATED in 1 BOTTLE (76420-032-10) | September 16, 2022 |
| 76420-032-15 | 76420-032 | Asclemed USA, Inc. | 15 TABLET, FILM COATED in 1 BOTTLE (76420-032-15) | September 16, 2022 |
| 76420-032-20 | 76420-032 | Asclemed USA, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (76420-032-20) | September 16, 2022 |
| 76420-032-30 | 76420-032 | Asclemed USA, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (76420-032-30) | September 16, 2022 |
| 76420-032-60 | 76420-032 | Asclemed USA, Inc. | 60 TABLET, FILM COATED in 1 BOTTLE (76420-032-60) | September 16, 2022 |
| 76420-032-90 | 76420-032 | Asclemed USA, Inc. | 90 TABLET, FILM COATED in 1 BOTTLE (76420-032-90) | September 16, 2022 |
| 69452-275-20 | 69452-275 | Bionpharma Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (69452-275-20) | March 10, 2023 |
| 63629-2974-0 | 63629-2974 | Bryant Ranch Prepack | 3 TABLET, FILM COATED in 1 BOTTLE (63629-2974-0) | May 9, 2011 |
| 63629-2974-1 | 63629-2974 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (63629-2974-1) | April 3, 2009 |
| 63629-2974-2 | 63629-2974 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (63629-2974-2) | March 9, 2006 |
| 63629-2974-3 | 63629-2974 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (63629-2974-3) | April 3, 2009 |
| 63629-2974-4 | 63629-2974 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (63629-2974-4) | October 9, 2014 |
| 63629-2974-5 | 63629-2974 | Bryant Ranch Prepack | 16 TABLET, FILM COATED in 1 BOTTLE (63629-2974-5) | March 23, 2012 |
| 63629-2974-6 | 63629-2974 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (63629-2974-6) | March 31, 2014 |
| 63629-2974-7 | 63629-2974 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (63629-2974-7) | February 11, 2010 |
| 63629-2974-8 | 63629-2974 | Bryant Ranch Prepack | 5 TABLET, FILM COATED in 1 BOTTLE (63629-2974-8) | April 11, 2011 |
| 63629-2974-9 | 63629-2974 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (63629-2974-9) | December 22, 2021 |
| 71335-2136-0 | 71335-2136 | Bryant Ranch Prepack | 3 TABLET, FILM COATED in 1 BOTTLE (71335-2136-0) | August 2, 2022 |
| 71335-2136-1 | 71335-2136 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2136-1) | August 2, 2022 |
| 71335-2136-2 | 71335-2136 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2136-2) | August 2, 2022 |
| 71335-2136-3 | 71335-2136 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2136-3) | August 2, 2022 |
| 71335-2136-4 | 71335-2136 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2136-4) | August 2, 2022 |
| 71335-2136-5 | 71335-2136 | Bryant Ranch Prepack | 16 TABLET, FILM COATED in 1 BOTTLE (71335-2136-5) | August 2, 2022 |
| 71335-2136-6 | 71335-2136 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (71335-2136-6) | August 2, 2022 |
| 71335-2136-7 | 71335-2136 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2136-7) | August 2, 2022 |
| 71335-2136-8 | 71335-2136 | Bryant Ranch Prepack | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2136-8) | August 2, 2022 |
| 71335-2136-9 | 71335-2136 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2136-9) | August 2, 2022 |
| 71335-2444-0 | 71335-2444 | Bryant Ranch Prepack | 3 TABLET, FILM COATED in 1 BOTTLE (71335-2444-0) | July 15, 2024 |
| 71335-2444-1 | 71335-2444 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2444-1) | July 15, 2024 |
| 71335-2444-2 | 71335-2444 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2444-2) | July 15, 2024 |
| 71335-2444-3 | 71335-2444 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2444-3) | July 15, 2024 |
| 71335-2444-4 | 71335-2444 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2444-4) | July 15, 2024 |
| 71335-2444-5 | 71335-2444 | Bryant Ranch Prepack | 16 TABLET, FILM COATED in 1 BOTTLE (71335-2444-5) | July 15, 2024 |
| 71335-2444-6 | 71335-2444 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (71335-2444-6) | July 15, 2024 |
| 71335-2444-7 | 71335-2444 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2444-7) | July 15, 2024 |
| 71335-2444-8 | 71335-2444 | Bryant Ranch Prepack | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2444-8) | July 15, 2024 |
| 71335-2444-9 | 71335-2444 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2444-9) | July 15, 2024 |
| 71335-2658-0 | 71335-2658 | Bryant Ranch Prepack | 3 TABLET, FILM COATED in 1 BOTTLE (71335-2658-0) | June 23, 2025 |
| 71335-2658-1 | 71335-2658 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2658-1) | June 23, 2025 |
| 71335-2658-2 | 71335-2658 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2658-2) | June 23, 2025 |
| 71335-2658-3 | 71335-2658 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-2658-3) | June 23, 2025 |
| 71335-2658-4 | 71335-2658 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2658-4) | June 23, 2025 |
| 71335-2658-5 | 71335-2658 | Bryant Ranch Prepack | 16 TABLET, FILM COATED in 1 BOTTLE (71335-2658-5) | June 23, 2025 |
| 71335-2658-6 | 71335-2658 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (71335-2658-6) | June 23, 2025 |
| 71335-2658-7 | 71335-2658 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-2658-7) | June 23, 2025 |
| 71335-2658-8 | 71335-2658 | Bryant Ranch Prepack | 5 TABLET, FILM COATED in 1 BOTTLE (71335-2658-8) | June 23, 2025 |
| 71335-2658-9 | 71335-2658 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2658-9) | June 23, 2025 |
| 71335-3084-0 | 71335-3084 | Bryant Ranch Prepack | 3 TABLET, FILM COATED in 1 BOTTLE (71335-3084-0) | February 16, 2026 |
| 71335-3084-1 | 71335-3084 | Bryant Ranch Prepack | 30 TABLET, FILM COATED in 1 BOTTLE (71335-3084-1) | February 16, 2026 |
| 71335-3084-2 | 71335-3084 | Bryant Ranch Prepack | 10 TABLET, FILM COATED in 1 BOTTLE (71335-3084-2) | February 16, 2026 |
| 71335-3084-3 | 71335-3084 | Bryant Ranch Prepack | 20 TABLET, FILM COATED in 1 BOTTLE (71335-3084-3) | February 16, 2026 |
| 71335-3084-4 | 71335-3084 | Bryant Ranch Prepack | 90 TABLET, FILM COATED in 1 BOTTLE (71335-3084-4) | February 16, 2026 |
| 71335-3084-5 | 71335-3084 | Bryant Ranch Prepack | 16 TABLET, FILM COATED in 1 BOTTLE (71335-3084-5) | February 16, 2026 |
| 71335-3084-6 | 71335-3084 | Bryant Ranch Prepack | 8 TABLET, FILM COATED in 1 BOTTLE (71335-3084-6) | February 16, 2026 |
| 71335-3084-7 | 71335-3084 | Bryant Ranch Prepack | 15 TABLET, FILM COATED in 1 BOTTLE (71335-3084-7) | February 16, 2026 |
| 71335-3084-8 | 71335-3084 | Bryant Ranch Prepack | 5 TABLET, FILM COATED in 1 BOTTLE (71335-3084-8) | February 16, 2026 |
| 71335-3084-9 | 71335-3084 | Bryant Ranch Prepack | 100 TABLET, FILM COATED in 1 BOTTLE (71335-3084-9) | February 16, 2026 |
| 31722-686-01 | 31722-686 | Camber Pharmaceuticals, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (31722-686-01) | August 25, 2022 |
| 43598-139-01 | 43598-139 | DR. REDDY'S LABORATORIES, INC. | 100 TABLET, FILM COATED in 1 BOTTLE (43598-139-01) | May 24, 2022 |
| 72189-555-10 | 72189-555 | Direct_Rx | 10 TABLET, FILM COATED in 1 BOTTLE (72189-555-10) | June 3, 2024 |
| 72189-555-15 | 72189-555 | Direct_Rx | 15 TABLET, FILM COATED in 1 BOTTLE (72189-555-15) | June 3, 2024 |
| 72189-555-20 | 72189-555 | Direct_Rx | 20 TABLET, FILM COATED in 1 BOTTLE (72189-555-20) | June 3, 2024 |
| 72189-555-30 | 72189-555 | Direct_Rx | 30 TABLET, FILM COATED in 1 BOTTLE (72189-555-30) | June 3, 2024 |
| 51407-677-01 | 51407-677 | Golden State Medical Supply, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (51407-677-01) | August 17, 2022 |
| 87234-7695-1 | 87234-7695 | Injecta Medcial LLC | 10 TABLET, FILM COATED in 1 BOTTLE (87234-7695-1) | May 8, 2026 |
| 87234-7695-2 | 87234-7695 | Injecta Medcial LLC | 10 BLISTER PACK in 1 CARTON (87234-7695-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK | May 18, 2026 |
| 69315-260-01 | 69315-260 | Leading Pharma, LLC | 100 TABLET, FILM COATED in 1 BOTTLE (69315-260-01) | March 1, 2024 |
| 0904-7303-04 | 0904-7303 | Major Pharmaceuticals | 30 BLISTER PACK in 1 CARTON (0904-7303-04) / 1 TABLET, FILM COATED in 1 BLISTER PACK | August 30, 2024 |
| 0378-1134-01 | 0378-1134 | Mylan Pharmaceuticals Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-1134-01) | May 16, 2013 |
| 51655-170-20 | 51655-170 | Northwind Health Company, LLC | 20 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-170-20) | July 15, 2014 |
| 51655-170-54 | 51655-170 | Northwind Health Company, LLC | 15 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-170-54) | August 27, 2020 |
| 82868-020-15 | 82868-020 | Northwind Health Company, LLC | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-15) | October 19, 2023 |
| 82868-020-20 | 82868-020 | Northwind Health Company, LLC | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-020-20) | November 14, 2023 |
| 66267-418-20 | 66267-418 | NuCare Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (66267-418-20) | November 15, 2016 |
| 66267-418-30 | 66267-418 | NuCare Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (66267-418-30) | November 15, 2016 |
| 66267-832-04 | 66267-832 | NuCare Pharmaceuticals, Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (66267-832-04) | January 24, 2017 |
| 66267-832-08 | 66267-832 | NuCare Pharmaceuticals, Inc. | 8 TABLET, FILM COATED in 1 BOTTLE (66267-832-08) | January 24, 2017 |
| 68071-2983-2 | 68071-2983 | NuCare Pharmaceuticals,Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2) | June 19, 2023 |
| 68071-2983-8 | 68071-2983 | NuCare Pharmaceuticals,Inc. | 28 TABLET, FILM COATED in 1 BOTTLE (68071-2983-8) | April 25, 2025 |
| 68071-3591-4 | 68071-3591 | NuCare Pharmaceuticals,Inc. | 4 TABLET, FILM COATED in 1 BOTTLE (68071-3591-4) | April 5, 2024 |
| 43063-904-10 | 43063-904 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-10) | November 8, 2018 |
| 43063-904-15 | 43063-904 | PD-Rx Pharmaceuticals, Inc. | 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-15) | December 11, 2018 |
| 43063-904-20 | 43063-904 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-20) | December 17, 2018 |
| 43063-904-30 | 43063-904 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-904-30) | September 10, 2024 |
| 72789-437-01 | 72789-437 | PD-Rx Pharmaceuticals, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-01) | October 4, 2024 |
| 72789-437-10 | 72789-437 | PD-Rx Pharmaceuticals, Inc. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-10) | November 11, 2024 |
| 72789-437-20 | 72789-437 | PD-Rx Pharmaceuticals, Inc. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-437-20) | October 10, 2024 |
| 68788-4129-2 | 68788-4129 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-4129-2) | June 10, 2026 |
| 68788-4129-3 | 68788-4129 | Preferred Pharmaceuticals Inc. | 30 TABLET, FILM COATED in 1 BOTTLE (68788-4129-3) | June 10, 2026 |
| 68788-8701-2 | 68788-8701 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8701-2) | June 27, 2024 |
| 68788-8891-2 | 68788-8891 | Preferred Pharmaceuticals Inc. | 20 TABLET, FILM COATED in 1 BOTTLE (68788-8891-2) | September 23, 2025 |
| 63187-128-10 | 63187-128 | Proficient Rx LP | 10 TABLET, FILM COATED in 1 BOTTLE (63187-128-10) | March 1, 2021 |
| 63187-128-12 | 63187-128 | Proficient Rx LP | 12 TABLET, FILM COATED in 1 BOTTLE (63187-128-12) | February 8, 2022 |
| 63187-128-15 | 63187-128 | Proficient Rx LP | 15 TABLET, FILM COATED in 1 BOTTLE (63187-128-15) | June 1, 2016 |
| 63187-128-20 | 63187-128 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (63187-128-20) | July 6, 2014 |
| 63187-128-30 | 63187-128 | Proficient Rx LP | 30 TABLET, FILM COATED in 1 BOTTLE (63187-128-30) | June 1, 2016 |
| 63187-128-60 | 63187-128 | Proficient Rx LP | 60 TABLET, FILM COATED in 1 BOTTLE (63187-128-60) | June 1, 2016 |
| 63187-128-90 | 63187-128 | Proficient Rx LP | 90 TABLET, FILM COATED in 1 BOTTLE (63187-128-90) | June 1, 2016 |
| 82804-248-15 | 82804-248 | Proficient Rx LP | 15 TABLET, FILM COATED in 1 BOTTLE (82804-248-15) | October 15, 2025 |
| 82804-248-20 | 82804-248 | Proficient Rx LP | 20 TABLET, FILM COATED in 1 BOTTLE (82804-248-20) | October 15, 2025 |
| 70518-0048-6 | 70518-0048 | REMEDYREPACK INC. | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0048-6) | November 19, 2025 |
| 70518-4161-1 | 70518-4161 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-1) | September 13, 2024 |
| 70518-4161-2 | 70518-4161 | REMEDYREPACK INC. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-2) | September 26, 2024 |
| 70518-4161-3 | 70518-4161 | REMEDYREPACK INC. | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4161-3) | December 22, 2025 |
| 70518-4255-0 | 70518-4255 | REMEDYREPACK INC. | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-0) | January 15, 2025 |
| 70518-4255-1 | 70518-4255 | REMEDYREPACK INC. | 12 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-1) | May 15, 2026 |
| 70518-4255-2 | 70518-4255 | REMEDYREPACK INC. | 21 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-2) | July 26, 2026 |
| 70518-4255-3 | 70518-4255 | REMEDYREPACK INC. | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4255-3) | August 6, 2026 |
| 67296-2163-1 | 67296-2163 | Redpharm Drug | 10 TABLET, FILM COATED in 1 BOTTLE (67296-2163-1) | January 18, 2025 |
| 67296-2163-2 | 67296-2163 | Redpharm Drug | 20 TABLET, FILM COATED in 1 BOTTLE (67296-2163-2) | January 18, 2025 |
| 67296-2171-1 | 67296-2171 | Redpharm Drug | 20 TABLET, FILM COATED in 1 BOTTLE (67296-2171-1) | March 10, 2023 |
| 67296-2171-2 | 67296-2171 | Redpharm Drug | 10 TABLET, FILM COATED in 1 BOTTLE (67296-2171-2) | March 10, 2023 |
| 67296-2230-1 | 67296-2230 | Redpharm Drug | 10 TABLET, FILM COATED in 1 BOTTLE (67296-2230-1) | November 10, 2022 |
| 67296-2230-2 | 67296-2230 | Redpharm Drug | 20 TABLET, FILM COATED in 1 BOTTLE (67296-2230-2) | November 10, 2022 |
| 85766-035-00 | 85766-035 | Sportpharm LLC | 1 TABLET, FILM COATED in 1 BOTTLE (85766-035-00) | August 17, 2026 |
| 85766-035-01 | 85766-035 | Sportpharm LLC | 100 TABLET, FILM COATED in 1 BOTTLE (85766-035-01) | August 7, 2025 |
| 85766-035-02 | 85766-035 | Sportpharm LLC | 2 TABLET, FILM COATED in 1 BOTTLE (85766-035-02) | August 12, 2026 |
| 85766-035-06 | 85766-035 | Sportpharm LLC | 6 TABLET, FILM COATED in 1 BOTTLE (85766-035-06) | April 5, 2026 |
| 85766-035-10 | 85766-035 | Sportpharm LLC | 10 TABLET, FILM COATED in 1 BOTTLE (85766-035-10) | August 7, 2025 |
| 85766-035-14 | 85766-035 | Sportpharm LLC | 14 TABLET, FILM COATED in 1 BOTTLE (85766-035-14) | August 7, 2025 |
| 85766-035-20 | 85766-035 | Sportpharm LLC | 20 TABLET, FILM COATED in 1 BOTTLE (85766-035-20) | August 7, 2025 |
| 85766-035-30 | 85766-035 | Sportpharm LLC | 30 TABLET, FILM COATED in 1 BOTTLE (85766-035-30) | August 7, 2025 |
| 85766-035-60 | 85766-035 | Sportpharm LLC | 60 TABLET, FILM COATED in 1 BOTTLE (85766-035-60) | August 7, 2025 |
| 85766-035-90 | 85766-035 | Sportpharm LLC | 90 TABLET, FILM COATED in 1 BOTTLE (85766-035-90) | August 7, 2025 |
| 60760-704-20 | 60760-704 | St. Mary's Medical Park Pharmacy | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-704-20) | January 29, 2025 |
| 0093-0314-01 | 0093-0314 | Teva Pharmaceuticals USA, Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0314-01) | June 17, 1998 |
| 0093-0314-77 | 0093-0314 | Teva Pharmaceuticals USA, Inc. | 42328 TABLET, FILM COATED in 1 CONTAINER (0093-0314-77) | October 7, 2024 |
| 70771-1747-1 | 70771-1747 | Zydus Lifesciences Limited | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1747-1) | November 10, 2022 |
| 70710-1710-1 | 70710-1710 | Zydus Pharmaceuticals (USA) Inc. | 100 TABLET, FILM COATED in 1 BOTTLE (70710-1710-1) | November 10, 2022 |
| 50090-0601 | 50090-0601 | A-S Medication Solutions | — | June 17, 1998 |
| 50090-7265 | 50090-7265 | A-S Medication Solutions | — | March 10, 2023 |
| 50090-7453 | 50090-7453 | A-S Medication Solutions | — | May 23, 2022 |
| 50090-7638 | 50090-7638 | A-S Medication Solutions | — | January 18, 2025 |
| 50090-7695 | 50090-7695 | A-S Medication Solutions | — | August 25, 2022 |
| 50090-7808 | 50090-7808 | A-S Medication Solutions | — | November 10, 2022 |
| 80425-0139 | 80425-0139 | Advanced Rx Pharmacy of Tennessee, LLC | — | June 17, 1998 |
| 80425-0267 | 80425-0267 | Advanced Rx Pharmacy of Tennessee, LLC | — | February 17, 2023 |
| 80425-0489 | 80425-0489 | Advanced Rx of Tennessee, LLC | — | January 30, 2025 |
| 27241-316 | 27241-316 | Ajanta Pharma USA Inc. | — | January 18, 2025 |
| 60687-104 | 60687-104 | American Health Packaging | — | March 23, 2021 |
| 87564-018 | 87564-018 | Amerisyn LLC | — | July 26, 2026 |
| 69292-650 | 69292-650 | Amici Pharma Inc. | — | December 22, 2025 |
| 76420-032 | 76420-032 | Asclemed USA, Inc. | — | June 17, 1998 |
| 69452-275 | 69452-275 | Bionpharma Inc. | — | March 10, 2023 |
| 63629-2974 | 63629-2974 | Bryant Ranch Prepack | — | June 17, 1998 |
| 71335-2136 | 71335-2136 | Bryant Ranch Prepack | — | May 23, 2022 |
| 71335-2444 | 71335-2444 | Bryant Ranch Prepack | — | March 10, 2023 |
| 71335-2658 | 71335-2658 | Bryant Ranch Prepack | — | January 18, 2025 |
| 71335-3084 | 71335-3084 | Bryant Ranch Prepack | — | November 10, 2022 |
| 31722-686 | 31722-686 | Camber Pharmaceuticals, Inc. | — | August 25, 2022 |
| 43598-139 | 43598-139 | DR. REDDY'S LABORATORIES, INC. | — | May 23, 2022 |
| 72189-555 | 72189-555 | Direct_Rx | — | June 3, 2024 |
| 51407-677 | 51407-677 | Golden State Medical Supply, Inc. | — | March 23, 2022 |
| 87234-7695 | 87234-7695 | Injecta Medcial LLC | — | May 18, 2026 |
| 69315-260 | 69315-260 | Leading Pharma, LLC | — | March 1, 2024 |
| 0904-7303 | 0904-7303 | Major Pharmaceuticals | — | August 30, 2024 |
| 0378-1134 | 0378-1134 | Mylan Pharmaceuticals Inc. | — | May 16, 2013 |
| 51655-170 | 51655-170 | Northwind Health Company, LLC | — | July 15, 2014 |
| 82868-020 | 82868-020 | Northwind Health Company, LLC | — | October 19, 2023 |
| 66267-418 | 66267-418 | NuCare Pharmaceuticals, Inc. | — | June 17, 1998 |
| 66267-832 | 66267-832 | NuCare Pharmaceuticals, Inc. | — | June 17, 1998 |
| 68071-2983 | 68071-2983 | NuCare Pharmaceuticals,Inc. | — | November 10, 2022 |
| 68071-3591 | 68071-3591 | NuCare Pharmaceuticals,Inc. | — | November 10, 2022 |
| 43063-904 | 43063-904 | PD-Rx Pharmaceuticals, Inc. | — | June 17, 1998 |
| 72789-437 | 72789-437 | PD-Rx Pharmaceuticals, Inc. | — | March 1, 2024 |
| 68788-4129 | 68788-4129 | Preferred Pharmaceuticals Inc. | — | June 10, 2026 |
| 68788-8701 | 68788-8701 | Preferred Pharmaceuticals Inc. | — | June 27, 2024 |
| 68788-8891 | 68788-8891 | Preferred Pharmaceuticals Inc. | — | September 23, 2025 |
| 63187-128 | 63187-128 | Proficient Rx LP | — | June 17, 1998 |
| 82804-248 | 82804-248 | Proficient Rx LP | — | March 10, 2023 |
| 70518-0048 | 70518-0048 | REMEDYREPACK INC. | — | December 9, 2016 |
| 70518-4161 | 70518-4161 | REMEDYREPACK INC. | — | August 15, 2024 |
| 70518-4255 | 70518-4255 | REMEDYREPACK INC. | — | January 15, 2025 |
| 67296-2163 | 67296-2163 | Redpharm Drug | — | January 18, 2025 |
| 67296-2171 | 67296-2171 | Redpharm Drug | — | March 10, 2023 |
| 67296-2230 | 67296-2230 | Redpharm Drug | — | November 10, 2022 |
| 85766-035 | 85766-035 | Sportpharm LLC | — | June 17, 1998 |
| 60760-704 | 60760-704 | St. Mary's Medical Park Pharmacy | — | January 29, 2025 |
| 0093-0314 | 0093-0314 | Teva Pharmaceuticals USA, Inc. | — | June 17, 1998 |
| 70771-1747 | 70771-1747 | Zydus Lifesciences Limited | — | November 10, 2022 |
| 70710-1710 | 70710-1710 | Zydus Pharmaceuticals (USA) Inc. | — | November 10, 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.