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Spironolactone
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 |
|---|---|---|
| Aldosterone Antagonist [EPC] | EPC | All 10 members |
| Aldosterone Antagonists [MoA] | MoA | All 10 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 040750-001 | SPIRONOLACTONE | TABLET | SPIRONOLACTONE | Prescription | AB | ||
| 040750-002 | SPIRONOLACTONE | TABLET | SPIRONOLACTONE | Prescription | AB | ||
| 040750-003 | SPIRONOLACTONE | TABLET | SPIRONOLACTONE | 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 | 34 | Labeling | Approved | August 13, 2026 | Standard |
| Supplement | 29 | Labeling | Approved | June 23, 2023 | Standard |
| Supplement | 26 | Labeling | Approved | February 26, 2021 | Standard |
| Supplement | 17 | Labeling | Approved | October 30, 2015 | Standard |
| Supplement | 15 | Labeling | Approved | September 22, 2014 | Standard |
| Supplement | 12 | Labeling | Approved | September 22, 2014 | Standard |
| Supplement | 7 | Labeling | Approved | September 22, 2014 | — |
| Supplement | 3 | Labeling | Approved | October 31, 2011 | — |
| Original application | 1 | Approved | August 29, 2006 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260831). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug Labeling1 INDICATIONS AND USAGE Spironolactone is an aldosterone antagonist indicated for: • The treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( Error! Hyperlink reference not valid. ). • Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( Error! Hyperlink reference not valid. ). • The management of edema in adult patients who are cirrhotic when edema is not responsive to fluid and sodium restrictions and in the setting of nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics produce an inadequate response ( 1.3 ). • Treatment of primary hyperaldosteronism for: ( 1.4 ) o Short-term preoperative treatment o Long-term maintenance for patients with discrete aldosterone-producing adrenal adenomas who are not candidates for surgery and patients with bilateral micro or macronodular adrenal hyperplasia 1.1 Heart Failure Spironolactone is indicated for treatment of NYHA Class III-IV heart failure and reduced ejection fraction to increase survival, manage edema, and reduce the need for hospitalization for heart failure. Spironolactone is usually administered in conjunction with other heart failure therapies. 1.2 Hypertension Spironolactone is indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. 1.3 Edema …
Dosage and Administration
openFDA Drug Labeling2 DOSAGE AND ADMINISTRATION • Heart Failure: Initiate treatment at 25 mg once daily ( Error! Hyperlink reference not valid. ). • Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses ( Error! Hyperlink reference not valid. ). • Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses ( Error! Hyperlink reference not valid. ). • Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery. In patients unsuitable for surgery use the lowest effective dosage determined for the individual patient ( Error! Hyperlink reference not valid. ). 2.1 General Considerations Spironolactone can be taken with or without food, but should be taken consistently with respect to food [see Error! Hyperlink reference not valid. ] . 2.2 Treatment of Heart Failure In patients with serum potassium ≤5.0 mEq/L and eGFR >50 mL/min/1.73 m2, initiate treatment at 25 mg once daily. Patients who tolerate 25 mg once daily may have their dosage increased to 50 mg once daily as clinically indicated. Patients who develop hyperkalemia on 25 mg once daily may have their dosage reduced to 25 mg every other day [see Error! Hyperlink reference not valid. ] . In patients with an eGFR between 30 and 50 mL/min/1.73 m 2 , consider initiating therapy at 25 mg every other day because of the risk of hyperkalemia [see Error! Hyperlink reference not valid. ]. 2.3 Treatment of Essential Hypertension The recommended initial daily dose is 25 to 100 mg of spironolactone administered in either single or divided doses is recommended. Dosage can be titrated at two-week intervals. Doses greater than 100 mg/day generally do not provide additional reductions in blood pressure. 2.4 Treatment of Edema In patients with cirrhosis, initiate therapy in a hospital setting and titrate slowly [see Error! Hyperlink reference not valid. ] . The recommended initial daily dosage is 100 mg of spironolactone administered in either single or divided doses, but may range from 25 to 200 mg daily. When given as the sole agent for diuresis, administer for at least five days before increasing dose to obtain desired effect. 2.5 Treatment of Primary Hyperaldosteronism Administer spironolactone in doses of 100 to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, spironolactone can be used as long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
Dosage Forms and Strengths
openFDA Drug Labeling3 DOSAGE FORMS AND STRENGTHS Tablets: 25 mg round, white to off-white, convex, coated, debossed with 852 on one side and debossed with “O” on the other side. Tablets: 50 mg oval, white to off-white, scored, convex, coated, debossed with 853 left of the bisect on one side and debossed with “O” on the other side. Tablets: 100 mg round, white to off-white, scored, convex, coated, debossed with 854 above the bisect on one side and debossed with “O” on the other side. Tablets: 25 mg, 50 mg, and 100 mg ( 3 ).
Contraindications
openFDA Drug Labeling4 CONTRAINDICATIONS Spironolactone is contraindicated in the patients with: • Hyperkalemia • Addison’s disease • Concomitant use of eplerenone Spironolactone is contraindicated in patients with ( 4 ): • Hyperkalemia • Addison’s disease • Concomitant use of eplerenone
Warnings and Cautions
openFDA Drug Labeling5 WARNINGS AND PRECAUTIONS • Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( Error! Hyperlink reference not valid. ). • Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( Error! Hyperlink reference not valid. ). • Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( Error! Hyperlink reference not valid. ). • Gynecomastia: Spironolactone can cause gynecomastia ( Error! Hyperlink reference not valid. ). 5.1 Hyperkalemia Spironolactone can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium supplementation, potassium-containing salt substitutes or drugs that increase potassium, such as angiotensin converting enzyme inhibitors and angiotensin receptor blockers [see Drug Interactions (7.1) ] . Monitor serum potassium within 1 week of initiation or titration of spironolactone and regularly thereafter. More frequent monitoring may be needed when spironolactone is given with other drugs that cause hyperkalemia or in patients with impaired renal function. If hyperkalemia occurs, decrease the dose or discontinue spironolactone and treat hyperkalemia. 5.2 Hypotension and Worsening Renal Function Excessive diuresis may cause symptomatic dehydration, hypotension and worsening renal function, particularly in salt-depleted patients or those taking angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Worsening of renal function can also occur with concomitant use of nephrotoxic drugs (e.g., aminoglycosides, cisplatin, and NSAIDs). Monitor volume status and renal function periodically. 5.3 Electrolyte and Metabolic Abnormalities In addition to causing hyperkalemia, spironolactone can cause hyponatremia, hypomagnesemia, hypocalcemia, hypochloremic alkalosis, and hyperglycemia. Asymptomatic hyperuricemia can occur and rarely gout is precipitated. Monitor serum electrolytes, uric acid and blood glucose periodically. 5.4 Gynecomastia Spironolactone can cause gynecomastia. In Randomized Spironolactone Evaluation Study, patients with heart failure treated with a mean dose of 26 mg of spironolactone once daily, about 9% of the male subjects developed gynecomastia. The risk of gynecomastia increases in a dose-dependent manner with an onset that varies widely from 1-2 months to over a year. Gynecomastia is usually reversible.
Adverse Reactions
openFDA Drug Labeling6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Hyperkalemia [see Error! Hyperlink reference not valid. ] • Hypotension and Worsening Renal Function [see Error! Hyperlink reference not valid. ] • Electrolyte and Metabolic Abnormalities [see Error! Hyperlink reference not valid. ] • Gynecomastia [see Error! Hyperlink reference not valid. ] • Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Error! Hyperlink reference not valid. ] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive: Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive: Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic: Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity: Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism: Hyperkalemia, electrolyte disturbances [see Error! Hyperlink reference not valid. , Error! Hyperlink reference not valid. ] , hyponatremia, hypovolemia. Musculoskeletal : Leg cramps. Nervous system/psychiatric: Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness. Liver/biliary: A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration. Renal: Renal dysfunction (including renal failure). Skin: Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis. The most common adverse reaction with spironolactone treatment is gynecomastia ( Error! Hyperlink reference not valid. , 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Oxford, at 1-844-508-1455, 8:00 am – 4:30 ET, Monday – Friday or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug Interactions
openFDA Drug Labeling7 DRUG INTERACTIONS • Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( Error! Hyperlink reference not valid. , 7.1 ). • Lithium: Increased risk of lithium toxicity ( Error! Hyperlink reference not valid. ). • NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone ( Error! Hyperlink reference not valid. ). • Digoxin: spironolactone can interfere with radioimmunologic assays of digoxin exposure ( Error! Hyperlink reference not valid. . • Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( Error! Hyperlink reference not valid. ). • Acetylsalicylic Acid (ASA): ASA may reduce the efficacy of spironolactone ( Error! Hyperlink reference not valid. ) • Abiraterone: May increase prostate-specific antigen (PSA) levels ( Error! Hyperlink reference not valid. ). 7.1 Drugs and Supplements Increasing Serum Potassium Concomitant administration of spironolactone with potassium supplementation or drugs that can increase potassium may lead to severe hyperkalemia. In general, discontinue potassium supplementation in heart failure patients who start spironolactone [see Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ] . Check serum potassium levels when ACE inhibitor or ARB therapy is altered in patients receiving spironolactone. Examples of drugs that can increase potassium include: • ACE inhibitors • angiotensin receptor blockers • non-steroidal anti-inflammatory drugs (NSAIDs) • heparin and low molecular weight heparin • trimethoprim 7.2 Lithium Like other diuretics, spironolactone reduces the renal clearance of lithium, thus increasing the risk of lithium toxicity. Monitor lithium levels periodically when spironolactone is coadministered [see Error! Hyperlink reference not valid. ] . 7.3 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of diuretics. Therefore, when spironolactone and NSAIDs are used concomitantly, monitor closely to determine if the desired effect of the diuretic is obtained [see Error! Hyperlink reference not valid. ] . 7.4 Digoxin Spironolactone and its metabolites interfere with radioimmunoassays for digoxin and increase the apparent exposure to digoxin. It is unknown to what extent, if any, spironolactone may increase actual digoxin exposure. In patients taking concomitant digoxin, use an assay that does not interact with spironolactone. 7.5 Cholestyramine Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with cholestyramine. 7.6 Acetylsalicylic Acid Acetylsalicylic acid may reduce the efficacy of spironolactone. Therefore, when spironolactone and acetylsalicylic acid are used concomitantly, spironolactone may need to be titrated to higher maintenance dose and the patient should be observed closely to determine if the desired effect is obtained [see Error! Hyperlink reference not valid. ] . 7.7 Abiraterone Spironolactone binds to the androgen receptor and may increase prostate-specific antigen (PSA) levels in abiraterone-treated prostate cancer patients. Concomitant use of spironolactone and abiraterone is not recommended.
Use in Specific Populations
openFDA Drug Labeling8 USE IN SPECIFIC POPULATIONS • Pregnancy: Based on animal data, spironolactone may affect sex differentiation of the male during embryogenesis ( Error! Hyperlink reference not valid. ). 8.1 Pregnancy Risk Summary Based on mechanism of action and findings in animal studies, spironolactone may affect sex differentiation of the male during embryogenesis [see Error! Hyperlink reference not valid. ] . Rat embryofetal studies report feminization of male fetuses and endocrine dysfunction in females exposed to spironolactone in utero. Limited available data from published case reports and case series did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone . There are risks to the mother and fetus associated with heart failure, cirrhosis and poorly controlled hypertension during pregnancy [see Error! Hyperlink reference not valid. ] . Because of the potential risk to the male fetus due to anti-androgenic properties of spironolactone and animal data, avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Pregnant women with congestive heart failure are at increased risk for preterm birth. Stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. Clinical classification of heart disease may worsen with pregnancy and lead to maternal death. Closely monitor pregnant patients for destabilization of their heart failure . Pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction and maternal death. Outcomes are worse with coexisting esophageal varices. Pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. Hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). Hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. Data Animal Data Teratology studies with spironolactone have been carried out in mice and rabbits at doses of up to 20 mg/kg/day. On a body surface area basis, this dose in the mouse is substantially below the maximum recommended human dose and, in the rabbit, approximates the maximum recommended human dose. No teratogenic or other embryotoxic effects were observed in mice, but the 20 mg/kg dose caused an increased rate of resorption and a lower number of live fetuses in rabbits. Because of its antiandrogenic activity and the requirement of testosterone for male morphogenesis, spironolactone may have the potential for adversely affecting sex differentiation of the male during embryogenesis. When administered to rats at 200 mg/kg/day between gestation days 13 and 21 (late embryogenesis and fetal development), feminization of male fetuses was observed. Offspring exposed during late pregnancy to 50 and 100 mg/kg/day doses of spironolactone exhibited changes in the reproductive tract including dose-dependent decreases in weights of the ventral prostate and seminal vesicle in males, ovaries and uteri that were enlarged in females, and other indications of endocrine dysfunction, that persisted into adulthood. Spironolactone has known endocrine effects in animals including progestational and antiandrogenic effects. 8.2 Lactation Risk Summary Spironolactone is not present in breastmilk; however, l …
Mechanism of Action
openFDA Drug Labeling12.1 Mechanism of Action Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. Spironolactone causes increased amounts of sodium and water to be excreted, while potassium is retained. Spironolactone acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents that act more proximally in the renal tubule.
Description
openFDA Drug Labeling11 DESCRIPTION Spironolactone oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17 hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following structural formula: Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform. Inactive ingredients include calcium sulfate, hypromellose, magnesium stearate, microcrystalline cellulose, N & A mint flavor, polyethylene glycol, polysorbate 80, povidone, pregelatinized corn starch, sodium starch glycolate, talc, and titanium dioxide 20
Overdosage
openFDA Drug Labeling10 OVERDOSAGE The oral LD 50 of spironolactone is greater than 1000 mg/kg in mice, rats, and rabbits. Acute overdosage of spironolactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function. Treatment: Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions. Patients who have renal impairment may develop hyperkalemia. In such cases, discontinue spironolactone.
How Supplied / Storage and Handling
openFDA Drug Labeling16 HOW SUPPLIED/STORAGE AND HANDLING Spironolactone 25 mg tablets are round, white to off-white, convex, coated, debossed with 852 on one side and debossed with “O” on the other side, supplied as: NDC Number Size 76420-925-30 (repackaged from 69584-852-XX) bottle of 30 76420-925-60 (repackaged from 69584-852-XX) bottle of 60 76420-925-90 (repackaged from 69584-852-XX) bottle of 90 76420-925-01 (relabeled from 69584-852-10) bottle of 100 76420-925-05 (relabeled from 69584-852-50) bottle of 500 76420-925-00 (relabeled from 69584-852-90) bottle of 1000 76420-925-25 (relabeled from 69584-852-92) bottle of 2500 Spironolactone 50 mg tablets are oval, white to off-white, scored, convex, coated, debossed with 853 left of the bisect on one side and debossed with “O” on the other side, supplied as: NDC Number Size 76420-926-30 (repackaged from 69584-853-XX) bottle of 30 76420-926-60 (repackaged from 69584-853-XX) bottle of 60 76420-926-90 (repackaged from 69584-853-XX) bottle of 90 76420-926-01 (relabeled from 69584-853-10) bottle of 100 76420-926-05 (relabeled from 69584-853-50) bottle of 500 76420-926-00 (relabeled from 69584-853-90) bottle of 1000 Spironolactone 100 mg tablets are round, white to off-white, scored, convex, coated, debossed with 854 above of the bisect on one side and debossed with “O” on the other side, supplied as: NDC Number Size 76420-927-30 (repackaged from 69584-854-XX) bottle of 30 76420-927-60 (repackaged from 69584-854-XX) bottle of 60 76420-927-90 (repackaged from 69584-854-XX) bottle of 90 76420-927-01 (relabeled from 69584-854-10) bottle of 100 76420-927-05 (relabeled from 69584-854-50) bottle of 500 76420-927-00 (relabeled from 69584-854-90) bottle of 1000 Store below 77°F (25°C).
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: SPIRONOLACTONE. 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 |
|---|---|---|---|---|
| 50090-6369-0 | 50090-6369 | A-S Medication Solutions | 100 TABLET, COATED in 1 BOTTLE (50090-6369-0) | February 10, 2023 |
| 50090-6369-1 | 50090-6369 | A-S Medication Solutions | 30 TABLET, COATED in 1 BOTTLE (50090-6369-1) | February 16, 2023 |
| 50090-6369-6 | 50090-6369 | A-S Medication Solutions | 90 TABLET, COATED in 1 BOTTLE (50090-6369-6) | February 16, 2023 |
| 50090-6458-0 | 50090-6458 | A-S Medication Solutions | 100 TABLET, COATED in 1 BOTTLE (50090-6458-0) | May 1, 2023 |
| 50090-6458-1 | 50090-6458 | A-S Medication Solutions | 90 TABLET, COATED in 1 BOTTLE (50090-6458-1) | May 1, 2023 |
| 50090-6458-2 | 50090-6458 | A-S Medication Solutions | 30 TABLET, COATED in 1 BOTTLE (50090-6458-2) | May 1, 2023 |
| 50090-6539-0 | 50090-6539 | A-S Medication Solutions | 90 TABLET, COATED in 1 BOTTLE (50090-6539-0) | June 29, 2023 |
| 50090-6539-1 | 50090-6539 | A-S Medication Solutions | 30 TABLET, COATED in 1 BOTTLE (50090-6539-1) | June 29, 2023 |
| 50090-6600-0 | 50090-6600 | A-S Medication Solutions | 90 TABLET, COATED in 1 BOTTLE (50090-6600-0) | August 21, 2023 |
| 50090-7797-0 | 50090-7797 | A-S Medication Solutions | 90 TABLET, COATED in 1 BOTTLE (50090-7797-0) | November 25, 2025 |
| 76420-925-00 | 76420-925 | Asclemed USA, Inc. | 1000 TABLET, COATED in 1 BOTTLE (76420-925-00) | March 6, 2025 |
| 76420-925-01 | 76420-925 | Asclemed USA, Inc. | 100 TABLET, COATED in 1 BOTTLE (76420-925-01) | March 6, 2025 |
| 76420-925-05 | 76420-925 | Asclemed USA, Inc. | 500 TABLET, COATED in 1 BOTTLE (76420-925-05) | March 6, 2025 |
| 76420-925-25 | 76420-925 | Asclemed USA, Inc. | 2500 TABLET, COATED in 1 BOTTLE (76420-925-25) | March 6, 2025 |
| 76420-925-30 | 76420-925 | Asclemed USA, Inc. | 30 TABLET, COATED in 1 BOTTLE (76420-925-30) | March 6, 2025 |
| 76420-925-60 | 76420-925 | Asclemed USA, Inc. | 60 TABLET, COATED in 1 BOTTLE (76420-925-60) | March 6, 2025 |
| 76420-925-90 | 76420-925 | Asclemed USA, Inc. | 90 TABLET, COATED in 1 BOTTLE (76420-925-90) | March 6, 2025 |
| 76420-926-00 | 76420-926 | Asclemed USA, Inc. | 1000 TABLET, COATED in 1 BOTTLE (76420-926-00) | March 6, 2025 |
| 76420-926-01 | 76420-926 | Asclemed USA, Inc. | 100 TABLET, COATED in 1 BOTTLE (76420-926-01) | March 6, 2025 |
| 76420-926-05 | 76420-926 | Asclemed USA, Inc. | 500 TABLET, COATED in 1 BOTTLE (76420-926-05) | March 6, 2025 |
| 76420-926-30 | 76420-926 | Asclemed USA, Inc. | 30 TABLET, COATED in 1 BOTTLE (76420-926-30) | March 6, 2025 |
| 76420-926-60 | 76420-926 | Asclemed USA, Inc. | 60 TABLET, COATED in 1 BOTTLE (76420-926-60) | March 6, 2025 |
| 76420-926-90 | 76420-926 | Asclemed USA, Inc. | 90 TABLET, COATED in 1 BOTTLE (76420-926-90) | March 6, 2025 |
| 76420-927-00 | 76420-927 | Asclemed USA, Inc. | 1000 TABLET, COATED in 1 BOTTLE (76420-927-00) | March 6, 2025 |
| 76420-927-01 | 76420-927 | Asclemed USA, Inc. | 100 TABLET, COATED in 1 BOTTLE (76420-927-01) | March 6, 2025 |
| 76420-927-05 | 76420-927 | Asclemed USA, Inc. | 500 TABLET, COATED in 1 BOTTLE (76420-927-05) | March 6, 2025 |
| 76420-927-30 | 76420-927 | Asclemed USA, Inc. | 30 TABLET, COATED in 1 BOTTLE (76420-927-30) | March 6, 2025 |
| 76420-927-60 | 76420-927 | Asclemed USA, Inc. | 60 TABLET, COATED in 1 BOTTLE (76420-927-60) | March 6, 2025 |
| 76420-927-90 | 76420-927 | Asclemed USA, Inc. | 90 TABLET, COATED in 1 BOTTLE (76420-927-90) | March 6, 2025 |
| 67046-0613-3 | 67046-0613 | Coupler LLC | 30 TABLET, COATED in 1 BLISTER PACK (67046-0613-3) | July 7, 2026 |
| 67046-0744-3 | 67046-0744 | Coupler LLC | 30 TABLET, COATED in 1 BLISTER PACK (67046-0744-3) | June 2, 2026 |
| 67046-1636-3 | 67046-1636 | Coupler LLC | 30 TABLET, COATED in 1 BLISTER PACK (67046-1636-3) | December 30, 2025 |
| 72189-495-90 | 72189-495 | Direct_Rx | 90 TABLET, COATED in 1 BOTTLE (72189-495-90) | July 5, 2023 |
| 72189-496-30 | 72189-496 | Direct_Rx | 30 TABLET, COATED in 1 BOTTLE (72189-496-30) | July 6, 2023 |
| 72189-496-90 | 72189-496 | Direct_Rx | 90 TABLET, COATED in 1 BOTTLE (72189-496-90) | July 6, 2023 |
| 72189-497-30 | 72189-497 | Direct_Rx | 30 TABLET, COATED in 1 BOTTLE (72189-497-30) | July 6, 2023 |
| 72189-497-90 | 72189-497 | Direct_Rx | 90 TABLET, COATED in 1 BOTTLE (72189-497-90) | July 6, 2023 |
| 68071-3967-3 | 68071-3967 | NuCare Pharmaceuticals, Inc. | 30 TABLET, COATED in 1 BOTTLE (68071-3967-3) | February 20, 2026 |
| 68071-3969-1 | 68071-3969 | NuCare Pharmaceuticals,Inc. | 100 TABLET, COATED in 1 BOTTLE (68071-3969-1) | February 24, 2026 |
| 69584-852-09 | 69584-852 | Oxford Pharmaceuticals, LLC | 90 TABLET, COATED in 1 BOTTLE (69584-852-09) | February 17, 2026 |
| 69584-852-10 | 69584-852 | Oxford Pharmaceuticals, LLC | 100 TABLET, COATED in 1 BOTTLE (69584-852-10) | January 4, 2021 |
| 69584-852-50 | 69584-852 | Oxford Pharmaceuticals, LLC | 500 TABLET, COATED in 1 BOTTLE (69584-852-50) | January 4, 2021 |
| 69584-852-90 | 69584-852 | Oxford Pharmaceuticals, LLC | 1000 TABLET, COATED in 1 BOTTLE (69584-852-90) | January 4, 2021 |
| 69584-852-92 | 69584-852 | Oxford Pharmaceuticals, LLC | 2500 TABLET, COATED in 1 BOTTLE (69584-852-92) | January 4, 2021 |
| 69584-853-09 | 69584-853 | Oxford Pharmaceuticals, LLC | 90 TABLET, COATED in 1 BOTTLE (69584-853-09) | February 17, 2026 |
| 69584-853-10 | 69584-853 | Oxford Pharmaceuticals, LLC | 100 TABLET, COATED in 1 BOTTLE (69584-853-10) | January 4, 2021 |
| 69584-853-50 | 69584-853 | Oxford Pharmaceuticals, LLC | 500 TABLET, COATED in 1 BOTTLE (69584-853-50) | January 4, 2021 |
| 69584-853-90 | 69584-853 | Oxford Pharmaceuticals, LLC | 1000 TABLET, COATED in 1 BOTTLE (69584-853-90) | April 1, 2024 |
| 69584-854-09 | 69584-854 | Oxford Pharmaceuticals, LLC | 90 TABLET, COATED in 1 BOTTLE (69584-854-09) | February 17, 2026 |
| 69584-854-10 | 69584-854 | Oxford Pharmaceuticals, LLC | 100 TABLET, COATED in 1 BOTTLE (69584-854-10) | January 4, 2021 |
| 69584-854-50 | 69584-854 | Oxford Pharmaceuticals, LLC | 500 TABLET, COATED in 1 BOTTLE (69584-854-50) | January 4, 2021 |
| 69584-854-90 | 69584-854 | Oxford Pharmaceuticals, LLC | 1000 TABLET, COATED in 1 BOTTLE (69584-854-90) | April 1, 2024 |
| 72789-290-30 | 72789-290 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-30) | December 8, 2022 |
| 72789-290-60 | 72789-290 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-60) | December 8, 2022 |
| 72789-290-90 | 72789-290 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-90) | December 8, 2022 |
| 72789-290-95 | 72789-290 | PD-Rx Pharmaceuticals, Inc. | 1000 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-290-95) | December 12, 2022 |
| 72789-291-30 | 72789-291 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-30) | December 12, 2022 |
| 72789-291-60 | 72789-291 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-60) | December 12, 2022 |
| 72789-291-82 | 72789-291 | PD-Rx Pharmaceuticals, Inc. | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-82) | December 12, 2022 |
| 72789-291-90 | 72789-291 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-291-90) | December 12, 2022 |
| 72789-292-30 | 72789-292 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-30) | December 8, 2022 |
| 72789-292-60 | 72789-292 | PD-Rx Pharmaceuticals, Inc. | 60 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-60) | December 8, 2022 |
| 72789-292-82 | 72789-292 | PD-Rx Pharmaceuticals, Inc. | 500 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-82) | December 8, 2022 |
| 72789-292-90 | 72789-292 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (72789-292-90) | December 8, 2022 |
| 68788-8452-3 | 68788-8452 | Preferred Pharmaceuticals Inc. | 30 TABLET, COATED in 1 BOTTLE (68788-8452-3) | May 30, 2023 |
| 68788-8452-6 | 68788-8452 | Preferred Pharmaceuticals Inc. | 60 TABLET, COATED in 1 BOTTLE (68788-8452-6) | May 30, 2023 |
| 68788-8452-9 | 68788-8452 | Preferred Pharmaceuticals Inc. | 90 TABLET, COATED in 1 BOTTLE (68788-8452-9) | May 30, 2023 |
| 68788-8545-3 | 68788-8545 | Preferred Pharmaceuticals Inc. | 30 TABLET, COATED in 1 BOTTLE (68788-8545-3) | November 7, 2023 |
| 68788-8545-6 | 68788-8545 | Preferred Pharmaceuticals Inc. | 60 TABLET, COATED in 1 BOTTLE (68788-8545-6) | November 7, 2023 |
| 68788-8545-9 | 68788-8545 | Preferred Pharmaceuticals Inc. | 90 TABLET, COATED in 1 BOTTLE (68788-8545-9) | November 7, 2023 |
| 68788-8381-3 | 68788-8381 | Preferred Pharmaceuticals, Inc | 30 TABLET, COATED in 1 BOTTLE (68788-8381-3) | February 28, 2023 |
| 68788-8381-6 | 68788-8381 | Preferred Pharmaceuticals, Inc | 60 TABLET, COATED in 1 BOTTLE (68788-8381-6) | February 28, 2023 |
| 68788-8381-9 | 68788-8381 | Preferred Pharmaceuticals, Inc | 90 TABLET, COATED in 1 BOTTLE (68788-8381-9) | February 28, 2023 |
| 82804-205-30 | 82804-205 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-205-30) | March 12, 2025 |
| 82804-255-30 | 82804-255 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-255-30) | November 12, 2025 |
| 82804-255-90 | 82804-255 | Proficient Rx LP | 90 TABLET, COATED in 1 BOTTLE (82804-255-90) | May 14, 2026 |
| 82804-285-30 | 82804-285 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-285-30) | April 24, 2026 |
| 82804-975-00 | 82804-975 | Proficient Rx LP | 100 TABLET, COATED in 1 BOTTLE (82804-975-00) | February 13, 2025 |
| 82804-975-11 | 82804-975 | Proficient Rx LP | 1000 TABLET, COATED in 1 BOTTLE (82804-975-11) | February 13, 2025 |
| 82804-975-30 | 82804-975 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-975-30) | February 13, 2025 |
| 82804-975-55 | 82804-975 | Proficient Rx LP | 500 TABLET, COATED in 1 BOTTLE (82804-975-55) | February 13, 2025 |
| 82804-975-60 | 82804-975 | Proficient Rx LP | 60 TABLET, COATED in 1 BOTTLE (82804-975-60) | February 13, 2025 |
| 82804-975-72 | 82804-975 | Proficient Rx LP | 120 TABLET, COATED in 1 BOTTLE (82804-975-72) | February 13, 2025 |
| 82804-975-90 | 82804-975 | Proficient Rx LP | 90 TABLET, COATED in 1 BOTTLE (82804-975-90) | February 13, 2025 |
| 82804-976-00 | 82804-976 | Proficient Rx LP | 100 TABLET, COATED in 1 BOTTLE (82804-976-00) | February 13, 2025 |
| 82804-976-11 | 82804-976 | Proficient Rx LP | 1000 TABLET, COATED in 1 BOTTLE (82804-976-11) | February 13, 2025 |
| 82804-976-30 | 82804-976 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-976-30) | February 13, 2025 |
| 82804-976-55 | 82804-976 | Proficient Rx LP | 500 TABLET, COATED in 1 BOTTLE (82804-976-55) | February 13, 2025 |
| 82804-976-60 | 82804-976 | Proficient Rx LP | 60 TABLET, COATED in 1 BOTTLE (82804-976-60) | February 13, 2025 |
| 82804-976-72 | 82804-976 | Proficient Rx LP | 120 TABLET, COATED in 1 BOTTLE (82804-976-72) | February 13, 2025 |
| 82804-976-90 | 82804-976 | Proficient Rx LP | 90 TABLET, COATED in 1 BOTTLE (82804-976-90) | February 13, 2025 |
| 82804-977-00 | 82804-977 | Proficient Rx LP | 100 TABLET, COATED in 1 BOTTLE (82804-977-00) | February 13, 2025 |
| 82804-977-11 | 82804-977 | Proficient Rx LP | 1000 TABLET, COATED in 1 BOTTLE (82804-977-11) | February 13, 2025 |
| 82804-977-30 | 82804-977 | Proficient Rx LP | 30 TABLET, COATED in 1 BOTTLE (82804-977-30) | February 13, 2025 |
| 82804-977-55 | 82804-977 | Proficient Rx LP | 500 TABLET, COATED in 1 BOTTLE (82804-977-55) | February 13, 2025 |
| 82804-977-60 | 82804-977 | Proficient Rx LP | 60 TABLET, COATED in 1 BOTTLE (82804-977-60) | February 13, 2025 |
| 82804-977-72 | 82804-977 | Proficient Rx LP | 120 TABLET, COATED in 1 BOTTLE (82804-977-72) | February 13, 2025 |
| 82804-977-90 | 82804-977 | Proficient Rx LP | 90 TABLET, COATED in 1 BOTTLE (82804-977-90) | February 13, 2025 |
| 70518-3625-0 | 70518-3625 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BLISTER PACK (70518-3625-0) | January 27, 2023 |
| 70518-3625-1 | 70518-3625 | REMEDYREPACK INC. | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3625-1) | April 16, 2024 |
| 70518-3625-2 | 70518-3625 | REMEDYREPACK INC. | 90 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3625-2) | July 29, 2024 |
| 70518-3625-3 | 70518-3625 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3625-3) | March 25, 2025 |
| 70518-3625-4 | 70518-3625 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3625-4) / 1 TABLET, COATED in 1 POUCH (70518-3625-5) | August 18, 2025 |
| 70518-3625-6 | 70518-3625 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3625-6) | June 1, 2026 |
| 70518-3625-7 | 70518-3625 | REMEDYREPACK INC. | 100 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3625-7) | July 8, 2026 |
| 70518-3655-2 | 70518-3655 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BLISTER PACK (70518-3655-2) | April 10, 2023 |
| 70518-3655-3 | 70518-3655 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3655-3) / 1 TABLET, COATED in 1 POUCH (70518-3655-4) | August 17, 2025 |
| 70518-3655-5 | 70518-3655 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3655-5) | May 31, 2026 |
| 70518-3721-0 | 70518-3721 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BLISTER PACK (70518-3721-0) | April 24, 2023 |
| 70518-3721-2 | 70518-3721 | REMEDYREPACK INC. | 30 TABLET, COATED in 1 BOTTLE, PLASTIC (70518-3721-2) | August 27, 2025 |
| 70518-3721-3 | 70518-3721 | REMEDYREPACK INC. | 100 POUCH in 1 BOX (70518-3721-3) / 1 TABLET, COATED in 1 POUCH (70518-3721-4) | January 28, 2026 |
| 50090-6369 | 50090-6369 | A-S Medication Solutions | — | January 4, 2021 |
| 50090-6458 | 50090-6458 | A-S Medication Solutions | — | January 4, 2021 |
| 50090-6539 | 50090-6539 | A-S Medication Solutions | — | January 4, 2021 |
| 50090-6600 | 50090-6600 | A-S Medication Solutions | — | January 4, 2021 |
| 50090-7797 | 50090-7797 | A-S Medication Solutions | — | January 4, 2021 |
| 76420-925 | 76420-925 | Asclemed USA, Inc. | — | January 4, 2021 |
| 76420-926 | 76420-926 | Asclemed USA, Inc. | — | January 4, 2021 |
| 76420-927 | 76420-927 | Asclemed USA, Inc. | — | January 4, 2021 |
| 67046-0613 | 67046-0613 | Coupler LLC | — | July 7, 2026 |
| 67046-0744 | 67046-0744 | Coupler LLC | — | June 2, 2026 |
| 67046-1636 | 67046-1636 | Coupler LLC | — | December 30, 2025 |
| 72189-495 | 72189-495 | Direct_Rx | — | July 5, 2023 |
| 72189-496 | 72189-496 | Direct_Rx | — | July 6, 2023 |
| 72189-497 | 72189-497 | Direct_Rx | — | July 6, 2023 |
| 68071-3967 | 68071-3967 | NuCare Pharmaceuticals, Inc. | — | January 4, 2021 |
| 68071-3969 | 68071-3969 | NuCare Pharmaceuticals,Inc. | — | January 4, 2021 |
| 69584-852 | 69584-852 | Oxford Pharmaceuticals, LLC | — | January 4, 2021 |
| 69584-853 | 69584-853 | Oxford Pharmaceuticals, LLC | — | January 4, 2021 |
| 69584-854 | 69584-854 | Oxford Pharmaceuticals, LLC | — | January 4, 2021 |
| 72789-290 | 72789-290 | PD-Rx Pharmaceuticals, Inc. | — | January 4, 2021 |
| 72789-291 | 72789-291 | PD-Rx Pharmaceuticals, Inc. | — | January 4, 2021 |
| 72789-292 | 72789-292 | PD-Rx Pharmaceuticals, Inc. | — | January 4, 2021 |
| 68788-8452 | 68788-8452 | Preferred Pharmaceuticals Inc. | — | May 30, 2023 |
| 68788-8545 | 68788-8545 | Preferred Pharmaceuticals Inc. | — | November 7, 2023 |
| 68788-8381 | 68788-8381 | Preferred Pharmaceuticals, Inc | — | February 28, 2023 |
| 82804-205 | 82804-205 | Proficient Rx LP | — | January 4, 2021 |
| 82804-255 | 82804-255 | Proficient Rx LP | — | January 4, 2021 |
| 82804-285 | 82804-285 | Proficient Rx LP | — | January 4, 2021 |
| 82804-975 | 82804-975 | Proficient Rx LP | — | January 4, 2021 |
| 82804-976 | 82804-976 | Proficient Rx LP | — | January 4, 2021 |
| 82804-977 | 82804-977 | Proficient Rx LP | — | January 4, 2021 |
| 70518-3625 | 70518-3625 | REMEDYREPACK INC. | — | January 27, 2023 |
| 70518-3655 | 70518-3655 | REMEDYREPACK INC. | — | February 21, 2023 |
| 70518-3721 | 70518-3721 | REMEDYREPACK INC. | — | April 24, 2023 |
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.