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Atenolol
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 |
|---|---|---|
| Adrenergic beta-Antagonists [MoA] | MoA | All 72 members |
| beta-Adrenergic Blocker [EPC] | EPC | All 72 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 077443-001 | ATENOLOL | TABLET | ATENOLOL | Prescription | AB | ||
| 077443-002 | ATENOLOL | TABLET | ATENOLOL | Prescription | AB | ||
| 077443-003 | ATENOLOL | TABLET | ATENOLOL | Prescription | AB |
Therapeutic equivalence
Source: Orange BookWhat this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing
Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 16 | Labeling | Approved | July 30, 2025 | Standard |
| Supplement | 5 | Labeling | Approved | November 4, 2014 | Standard |
| Supplement | 3 | Labeling | Approved | November 28, 2011 | — |
| Supplement | 2 | Labeling | Approved | July 6, 2010 | — |
| Original application | 1 | Approved | September 13, 2006 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260720). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingIn Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, atenolol should be withdrawn. (see DOSAGE AND ADMINISTRATION ). Cessation of Therapy with Atenolol: Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension. (see DOSAGE AND ADMINISTRATION).
Cessation of Therapy with Atenolol: Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta-blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta-blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension. (see DOSAGE AND ADMINISTRATION).
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Hypertension Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal 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 including atenolol. 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 1 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. Atenolol tablets may be administered with other antihypertensive agents. Angina Pectoris Due to Coronary Atherosclerosis Atenolol tablets are indicated for the long-term management of patients with angina pectoris. Acute Myocardial Infarction Atenolol tablets are indicated in the management of hemodynamically stable patients with definite or suspected acute myocardial infarction to reduce cardiovascular mortality. Treatment can be initiated as soon as the patient's clinical condition allows. (See Error! Hyperlink reference not valid., Error! Hyperlink reference not valid. , and .) In general, there is no basis for treating patients like those who were excluded from the ISIS-1 trial (blood pressure less than 100 mm Hg systolic, heart rate less than 50 bpm) or have other reasons to avoid beta blockade. As noted above, some subgroups (e.g., elderly patients with systolic blood pressure below 120 mm Hg) seemed less likely to benefit.
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Hypertension The initial dose of atenolol tablets USP is 50 mg given as one tablet a day either alone or added to diuretic therapy. The full effect of this dose will usually be seen within one to two weeks. If an optimal response is not achieved, the dosage should be increased to atenolol tablets USP 100 mg given as one tablet a day. Increasing the dosage beyond 100 mg a day is unlikely to produce any further benefit. Atenolol tablets USP may be used alone or concomitantly with other antihypertensive agents including thiazide-type diuretics, hydralazine, prazosin, and alpha-methyldopa. Angina Pectoris The initial dose of atenolol tablets USP is 50 mg given as one tablet a day. If an optimal response is not achieved within one week, the dosage should be increased to atenolol tablets USP 100 mg given as one tablet a day. Some patients may require a dosage of 200 mg once a day for optimal effect. Twenty-four hour control with once daily dosing is achieved by giving doses larger than necessary to achieve an immediate maximum effect. The maximum early effect on exercise tolerance occurs with doses of 50 to 100 mg, but at these doses the effect at 24 hours is attenuated, averaging about 50% to 75% of that observed with once a day oral doses of 200 mg. Acute Myocardial Infarction In patients with definite or suspected acute myocardial infarction, treatment with atenolol I.V. injection should be initiated as soon as possible after the patient's arrival in the hospital and after eligibility is established. Such treatment should be initiated in a coronary care or similar unit immediately after the patient's hemodynamic condition has stabilized. Treatment should begin with the intravenous administration of 5 mg atenolol over 5 minutes followed by another 5 mg intravenous injection 10 minutes later. Atenolol I.V. injection should be administered under carefully controlled conditions including monitoring of blood pressure, heart rate, and electrocardiogram. Dilutions of atenolol I.V. injection in Dextrose Injection USP, Sodium Chloride Injection USP, or Sodium Chloride and Dextrose Injection may be used. These admixtures are stable for 48 hours if they are not used immediately. In patients who tolerate the full intravenous dose (10 mg), atenolol tablets USP, 50 mg should be initiated 10 minutes after the last intravenous dose followed by another 50 mg oral dose 12 hours later. Thereafter, atenolol tablets USP can be given orally either 100 mg once daily or 50 mg twice a day for a further 6 to 9 days or until discharge from the hospital. If bradycardia or hypotension requiring treatment or any other untoward effects occur, atenolol tablets USP should be discontinued (see full prescribing information prior to initiating therapy with atenolol tablets USP). Data from other beta blocker trials suggest that if there is any question concerning the use of IV beta blocker or clinical estimate that there is a contraindication, the IV beta blocker may be eliminated and patients fulfilling the safety criteria may be given atenolol tablets USP, 50 mg twice daily or 100 mg once a day for at least seven days (if the IV dosing is excluded). Although the demonstration of efficacy of atenolol tablets USP is based entirely on data from the first seven postinfarction days, data from other beta blocker trials suggest that treatment with beta blockers that are effective in the postinfarction setting may be continued for one to three years if there are no contraindications. Atenolol tablets USP is an additional treatment to standard coronary care unit therapy. Elderly Patients or Patients With Renal Impairment Atenolol tablets USP are excreted by the kidneys; consequently dosage should be adjusted in cases of severe impairment of renal function. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting greater frequency of decreased hepatic, renal, or cardiac fu …
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Atenolol tablets are contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. (See WARNINGS .) Atenolol tablets are contraindicated in those patients with a history of hypersensitivity to the atenolol or any of the drug product’s components.
Warnings
openFDA Drug LabelingWARNINGS Cardiac Failure Sympathetic stimulation is necessary in supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In patients with acute myocardial infarction, cardiac failure, which is not promptly and effectively controlled by 80 mg of intravenous furosemide or equivalent therapy, is a contraindication to beta blocker treatment. In Patients Without a History of Cardiac Failure Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be treated appropriately according to currently recommended guidelines, and the response observed closely. If cardiac failure continues despite adequate treatment, atenolol should be withdrawn (see DOSAGE AND ADMINISTRATION ). Cessation of Therapy with Atenolol: Patients with coronary artery disease, who are being treated with atenolol, should be advised against abrupt discontinuation of therapy. Severe exacerbation of angina and the occurrence of myocardial infarction and ventricular arrhythmias have been reported in angina patients following the abrupt discontinuation of therapy with beta blockers. The last two complications may occur with or without preceding exacerbation of the angina pectoris. As with other beta blockers, when discontinuation of atenolol is planned, the patients should be carefully observed and advised to limit physical activity to a minimum. If the angina worsens or acute coronary insufficiency develops, it is recommended that atenolol be promptly reinstituted, at least temporarily. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue atenolol therapy abruptly even in patients treated only for hypertension (see DOSAGE AND ADMINISTRATION). Concomitant Use of Calcium Channel Blockers Bradycardia and heart block can occur and the left ventricular end diastolic pressure can rise when beta blockers are administered with verapamil or diltiazem. Patients with preexisting conduction abnormalities or left ventricular dysfunction are particularly susceptible (see PRECAUTIONS ). Bronchospastic Diseases PATIENTS WITH BRONCHOSPASTIC DISEASE SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS. Because of its relative beta 1 selectivity, however, atenolol may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta 1 selectivity is not absolute, the lowest possible dose of atenolol should be used with therapy initiated at 50 mg and a beta 2 - stimulating agent (bronchodilator) should be made available. If dosage must be increased, dividing the dose should be considered in order to achieve lower peak blood levels. Major Surgery Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures. Diabetes and Hypoglycemia Atenolol should be used with caution in diabetic patients if a beta-blocking agent is required. Beta blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. At recommended doses atenolol does not potentiate insulin-induced hypoglycemia and, unlike nonselective beta blockers, does not delay recovery of blood glucose to normal levels. Thyrotoxicosis Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Abrupt withdrawal of beta blockade might precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom atenolol therapy is to be withdrawn should be monitored closely (see DOSAGE AND ADMINISTRATION ) …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Most adverse effects have been mild and transient. The frequency estimates in the following table were derived from controlled studies in hypertensive patients in which adverse reactions were either volunteered by the patient (US studies) or elicited, e.g., by checklist (foreign studies). The reported frequency of elicited adverse effects was higher for both atenolol and placebo-treated patients than when these reactions were volunteered. Where frequency of adverse effects of atenolol and placebo is similar, causal relationship to atenolol is uncertain. Volunteered (US Studies) Total- Volunteered and Elicited (Foreign + US Studies) Atenolol (n = 164) % Placebo (n = 206) % Atenolol (n = 399) % Placebo (n = 407) % CARDIOVASCULAR Bradycardia 3 0 3 0 Cold Extremities 0 0.5 12 5 Postural Hypotension 2 1 4 5 Leg Pain 0 0.5 3 1 CENTRAL NERVOUS SYSTEM/NEUROMUSCULAR Dizziness 4 1 13 6 Vertigo 2 0.5 2 0.2 Light - Headedness 1 0 3 0.7 Tiredness 0.6 0.5 26 13 Fatigue 3 1 6 5 Lethargy 1 0 3 0.7 Drowsiness 0.6 0 2 0.5 Depression 0.6 0.5 12 9 Dreaming 0 0 3 1 GASTROINTESTINAL Diarrhea 2 0 3 2 Nausea 4 1 3 1 RESPIRATORY (See WARNINGS ) Wheeziness 0 0 3 3 Dyspnea 0.6 1 6 4 Acute Myocardial Infarction In a series of investigations in the treatment of acute myocardial infarction, bradycardia and hypotension occurred more commonly, as expected for any beta-blocker, in atenolol-treated patients than in control patients. However, these usually responded to atropine and/or to withholding further dosage of atenolol. The incidence of heart failure was not increased by atenolol. Inotropic agents were infrequently used. The reported frequency of these and other events occurring during these investigations is given in the following table. In a study of 477 patients, the following adverse events were reported during either intravenous and/or oral atenolol administration: Conventional Therapy Plus Atenolol (n = 244) Conventional Therapy Alone (n = 233) Bradycardia 43 (18%) 24 (10%) Hypotension 60 (25%) 34 (15%) Bronchospasm 3 (1.2%) 2 (0.9%) Heart Failure 46 (19%) 56 (24%) Heart Block 11 (4.5%) 10 (4.3%) BBB + Major Axis Deviation 16 (6.6%) 28 (12%) Supraventricular Tachycardia 28 (11.5%) 45 (19%) Atrial Fibrillation 12 (5%) 29 (11%) Atrial Flutter 4 (1.6%) 7 (3%) Ventricular Tachycardia 39 (16%) 52 (22%) Cardiac Reinfarction 0 (0%) 6 (2.6%) Total Cardiac Arrests 4 (1.6%) 16 (6.9%) Nonfatal Cardiac Arrests 4 (1.6%) 12 (5.1%) Deaths 7 (2.9%) 16 (6.9%) Cardiogenic Shock 1 (0.4%) 4 (1.7%) Development of Ventricular Septal Defect 0 (0%) 2 (0.9%) Development of Mitral Regurgitation 0 (0%) 2 (0.9%) Renal Failure 1 (0.4%) 0 (0%) Pulmonary Emboli 3 (1.2%) 0 (0%) In the subsequent International Study of Infarct Survival (ISIS-1) including over 16,000 patients of whom 8,037 were randomized to receive atenolol treatment, the dosage of intravenous and subsequent oral atenolol was either discontinued or reduced for the following reasons: Reasons for Reduced Dosage I.V. Atenolol Reduced Dose ( first degree) 5 (.06%) 143 (1.7%) Cardiac Failure 1 (.01%) 233 (2.9%) Arrhythmias 3 (.04%) 22 (.27%) Bronchospasm 1 (.01%) 50 (.62%) * Full dosage was 10 mg and some patients received less than 10 mg but more than 5 mg. During postmarketing experience with atenolol, the following have been reported in temporal relationship to the use of the drug: elevated liver enzymes and/or bilirubin, hallucinations, headache, impotence, Peyronie's disease, postural hypotension which may be associated with syncope, psoriasiform rash or exacerbation of psoriasis, psychoses, purpura, reversible alopecia, thrombocytopenia, visual disturbance, sick sinus syndrome, and dry mouth. Atenolol, like other beta-blockers, has been associated with the development of antinuclear antibodies (ANA), lupus syndrome, and Raynaud's phenomenon. POTENTIAL ADVERSE EFFECTS In addition, a variety of adverse effects have been reported with other beta-adrenergic blocking agents, and may be considered pot …
Drug Interactions
openFDA Drug LabelingDrug Interactions Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents. Patients treated with atenolol tablets plus a catecholamine depletor should therefore be closely observed for evidence of hypotension and/or marked bradycardia which may produce vertigo, syncope, or postural hypotension. Calcium channel blockers may also have an additive effect when given with atenolol tablets (see WARNINGS ). Disopyramide is a Type I antiarrhythmic drug with potent negative inotropic and chronotropic effects. Disopyramide has been associated with severe bradycardia, asystole and heart failure when administered with beta-blockers. Amiodarone is an antiarrhythmic agent with negative chronotropic properties that may be additive to those seen with beta-blockers. Beta-blockers may exacerbate the rebound hypertension which can follow the withdrawal of clonidine. If the two drugs are coadministered, the beta-blocker should be withdrawn several days before the gradual withdrawal of clonidine. If replacing clonidine by beta-blocker therapy, the introduction of beta-blockers should be delayed for several days after clonidine administration has stopped. Concomitant use of prostaglandin synthase inhibiting drugs, e.g., indomethacin, may decrease the hypotensive effects of beta-blockers. Information on concurrent usage of atenolol and aspirin is limited. Data from several studies, i.e., TIMI-II, ISIS-2, currently do not suggest any clinical interaction between aspirin and beta-blockers in the acute myocardial infarction setting. While taking beta-blockers, patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge, either accidental, diagnostic or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat the allergic reaction. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia.
Description
openFDA Drug LabelingDESCRIPTION Atenolol, a synthetic, beta 1 -selective (cardioselective) adrenoreceptor blocking agent, may be chemically described as benzeneacetamide, 4 -[2’-hydroxy-3’-[(1- methylethyl) amino] propoxy]-. The molecular formula is C 14 H 22 N 2 O 3 and its structural formula is: Atenolol (free base) has a molecular weight of 266. It is a relatively polar hydrophilic compound with a water solubility of 26.5 mg/mL at 37°C and a log partition coefficient (octanol/water) of 0.23. It is freely soluble in 1N HCl (300 mg/mL at 25°C) and less soluble in chloroform (3 mg/mL at 25°C). Atenolol tablets, USP are available as 25 mg, 50 mg and 100 mg tablets for oral administration. Inactive Ingredients: Colloidal silicon dioxide, corn starch, magnesium carbonate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate. atenololtabs-figure-01
Overdosage
openFDA Drug LabelingOVERDOSAGE Overdosage with atenolol tablets has been reported with patients surviving acute doses as high as 5 g. One death was reported in a man who may have taken as much as 10 g acutely. The predominant symptoms reported following atenolol tablets overdose are lethargy, disorder of respiratory drive, wheezing, sinus pause and bradycardia. Additionally, common effects associated with overdosage of any beta-adrenergic blocking agent and which might also be expected in atenolol tablets overdose are congestive heart failure, hypotension, bronchospasm and/or hypoglycemia. Treatment of overdose should be directed to the removal of any unabsorbed drug by induced emesis, gastric lavage, or administration of activated charcoal. Atenolol tablets can be removed from the general circulation by hemodialysis. Other treatment modalities should be employed at the physician’s discretion and may include: BRADYCARDIA: Atropine intravenously. If there is no response to vagal blockade, give isoproterenol cautiously. In refractory cases, a transvenous cardiac pacemaker may be indicated. HEART BLOCK (SECOND OR THIRD DEGREE): Isoproterenol or transvenous cardiac pacemaker. CARDIAC FAILURE: Digitalize the patient and administer a diuretic. Glucagon has been reported to be useful. HYPOTENSION: Vasopressors such as dopamine or norepinephrine (levarterenol). Monitor blood pressure continuously. BRONCHOSPASM: A beta 2 stimulant such as isoproterenol or terbutaline and/or aminophylline. HYPOGLYCEMIA: Intravenous glucose. Based on the severity of symptoms, management may require intensive support care and facilities for applying cardiac and respiratory support.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Atenolol Tablets USP: Tablets of 25 mg atenolol, NDC 64980-437-01 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" engraved on one side and 25 engraved on the other side) are supplied in bottles of 100 tablets. Tablets of 25 mg atenolol, NDC 64980-437-10 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" engraved on one side and 25 engraved on the other side) are supplied in bottles of 1000 tablets. Tablets of 50 mg atenolol, NDC 64980-438-01 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" and "50" engraved on one side and lip like score engraved on the other side) are supplied in bottles of 100 tablets. Tablets of 50 mg atenolol, NDC 64980-438-10 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" and "50" engraved on one side and lip like score engraved on the other side) are supplied in bottles of 1000 tablets. Tablets of 100 mg atenolol, NDC 64980-439-01 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" and "100" engraved on one side and lip like score engraved on the other side) are supplied in bottles of 100 tablets. Tablets of 100 mg atenolol, NDC 64980-439-10 (circular, biconvex, film coated white to offwhite tablets identified with "ATN" and "100" engraved on one side and lip like score engraved on the other side) are supplied in bottles of 1000 tablets. Store at controlled room temperature 20°C to 25°C (68°F to 77°F). [See USP]. Dispense in a well-closed, light-resistant containers. Manufactured by : Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Mumbai 400 030, India Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 141689 Revised: 05/2025 Rising logo
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ATENOLOL. 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.
Recalls
Source: FDA Enforcement| Classification | Reported | Firm | Reason | Status |
|---|---|---|---|---|
| Class I | November 2, 2022 | Golden State Medical Supply Inc. | Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets | Terminated |
| Class II | March 29, 2017 | Zydus Pharmaceuticals USA Inc | Presence of Foreign Tablets/Capsules: Customer complaint that a bottle of atenolol 50 mg Tablets USP contained a paroxetine 20 mg tablet. | Terminated |
| Class II | October 15, 2014 | Zydus Pharmaceuticals USA Inc | Superpotent Drug: A complaint was reported by a pharmacist who stated several tablets were noticeably thicker in appearance. | Terminated |
| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0442-0 | 50090-0442 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-0442-0) | June 29, 2016 |
| 50090-0442-1 | 50090-0442 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0442-1) | June 29, 2016 |
| 50090-0442-7 | 50090-0442 | A-S Medication Solutions | 200 TABLET in 1 BOTTLE (50090-0442-7) | June 29, 2016 |
| 50090-0442-8 | 50090-0442 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-0442-8) | June 29, 2016 |
| 50090-3411-0 | 50090-3411 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3411-0) | November 28, 2014 |
| 50090-3411-2 | 50090-3411 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE, PLASTIC (50090-3411-2) | November 28, 2014 |
| 50090-3411-5 | 50090-3411 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3411-5) | March 22, 2018 |
| 50090-5363-0 | 50090-5363 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5363-0) | November 17, 2020 |
| 50090-5363-1 | 50090-5363 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5363-1) | October 19, 2022 |
| 50090-5363-7 | 50090-5363 | A-S Medication Solutions | 200 TABLET in 1 BOTTLE (50090-5363-7) | November 17, 2020 |
| 50090-5363-8 | 50090-5363 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5363-8) | November 17, 2020 |
| 50090-5367-0 | 50090-5367 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5367-0) | November 18, 2020 |
| 50090-5367-1 | 50090-5367 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5367-1) | November 18, 2020 |
| 50090-5367-7 | 50090-5367 | A-S Medication Solutions | 200 TABLET in 1 BOTTLE (50090-5367-7) | November 18, 2020 |
| 50090-5367-8 | 50090-5367 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5367-8) | November 18, 2020 |
| 50090-5738-0 | 50090-5738 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5738-0) | September 29, 2021 |
| 50090-5738-3 | 50090-5738 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5738-3) | September 29, 2021 |
| 50090-5738-5 | 50090-5738 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5738-5) | September 29, 2021 |
| 50090-5741-0 | 50090-5741 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-5741-0) | September 29, 2021 |
| 50090-5741-1 | 50090-5741 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-5741-1) | September 29, 2021 |
| 50090-5741-4 | 50090-5741 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-5741-4) | September 29, 2021 |
| 50090-5741-7 | 50090-5741 | A-S Medication Solutions | 200 TABLET in 1 BOTTLE (50090-5741-7) | September 29, 2021 |
| 50090-5741-8 | 50090-5741 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-5741-8) | September 29, 2021 |
| 50090-6241-0 | 50090-6241 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6241-0) | November 23, 2022 |
| 50090-6241-2 | 50090-6241 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6241-2) | November 23, 2022 |
| 50090-6241-5 | 50090-6241 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6241-5) | November 23, 2022 |
| 50090-6311-0 | 50090-6311 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6311-0) | January 5, 2023 |
| 50090-6311-3 | 50090-6311 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6311-3) | January 5, 2023 |
| 50090-6311-5 | 50090-6311 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6311-5) | January 5, 2023 |
| 50090-6779-0 | 50090-6779 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6779-0) | October 25, 2023 |
| 50090-6935-0 | 50090-6935 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6935-0) | December 14, 2023 |
| 50090-7561-0 | 50090-7561 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7561-0) | May 28, 2025 |
| 50090-7603-0 | 50090-7603 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7603-0) | July 15, 2025 |
| 50090-7847-0 | 50090-7847 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7847-0) | December 31, 2025 |
| 50090-8048-0 | 50090-8048 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-8048-0) | September 10, 2026 |
| 50090-8048-3 | 50090-8048 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-8048-3) | September 10, 2026 |
| 50090-8048-5 | 50090-8048 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-8048-5) | September 10, 2026 |
| 87063-177-01 | 87063-177 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-177-01) | May 19, 2026 |
| 87063-177-30 | 87063-177 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-177-30) | May 19, 2026 |
| 87063-177-60 | 87063-177 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-177-60) | May 19, 2026 |
| 87063-177-90 | 87063-177 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-177-90) | May 19, 2026 |
| 87063-178-01 | 87063-178 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-178-01) | May 19, 2026 |
| 87063-178-30 | 87063-178 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-178-30) | May 19, 2026 |
| 87063-178-60 | 87063-178 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-178-60) | May 19, 2026 |
| 87063-178-90 | 87063-178 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-178-90) | May 19, 2026 |
| 87063-179-01 | 87063-179 | ASCLEMED USA INC. | 100 TABLET in 1 BOTTLE (87063-179-01) | May 19, 2026 |
| 87063-179-30 | 87063-179 | ASCLEMED USA INC. | 30 TABLET in 1 BOTTLE (87063-179-30) | May 19, 2026 |
| 87063-179-60 | 87063-179 | ASCLEMED USA INC. | 60 TABLET in 1 BOTTLE (87063-179-60) | May 19, 2026 |
| 87063-179-90 | 87063-179 | ASCLEMED USA INC. | 90 TABLET in 1 BOTTLE (87063-179-90) | May 19, 2026 |
| 60687-605-01 | 60687-605 | American Health Packaging | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-605-01) / 1 TABLET in 1 BLISTER PACK (60687-605-11) | October 25, 2021 |
| 43353-834-30 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (43353-834-30) | December 27, 2014 |
| 43353-834-45 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE, PLASTIC (43353-834-45) | November 18, 2014 |
| 43353-834-60 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (43353-834-60) | December 4, 2014 |
| 43353-834-73 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | 135 TABLET in 1 BOTTLE, PLASTIC (43353-834-73) | December 4, 2014 |
| 43353-834-80 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE, PLASTIC (43353-834-80) | November 18, 2014 |
| 43353-986-60 | 43353-986 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (43353-986-60) | December 4, 2014 |
| 71610-658-30 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (71610-658-30) | August 24, 2022 |
| 71610-658-45 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE, PLASTIC (71610-658-45) | August 12, 2022 |
| 71610-658-60 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (71610-658-60) | August 24, 2022 |
| 71610-658-80 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE, PLASTIC (71610-658-80) | August 12, 2022 |
| 71610-658-92 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | 270 TABLET in 1 BOTTLE, PLASTIC (71610-658-92) | August 24, 2022 |
| 71610-857-30 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-857-30) | October 4, 2024 |
| 71610-857-45 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-857-45) | October 21, 2024 |
| 71610-857-53 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE (71610-857-53) | October 4, 2024 |
| 71610-857-60 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-857-60) | October 4, 2024 |
| 71610-857-80 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-857-80) | October 21, 2024 |
| 71610-861-30 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE (71610-861-30) | October 11, 2024 |
| 71610-861-45 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-861-45) | October 11, 2024 |
| 71610-861-60 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE (71610-861-60) | October 11, 2024 |
| 71610-861-73 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | 135 TABLET in 1 BOTTLE (71610-861-73) | October 11, 2024 |
| 71610-861-80 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE (71610-861-80) | October 11, 2024 |
| 65862-168-01 | 65862-168 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-168-01) | October 31, 2007 |
| 65862-168-76 | 65862-168 | Aurobindo Pharma Limited | 13000 TABLET in 1 BAG (65862-168-76) | October 31, 2007 |
| 65862-168-99 | 65862-168 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-168-99) | October 31, 2007 |
| 65862-169-01 | 65862-169 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-169-01) | October 31, 2007 |
| 65862-169-81 | 65862-169 | Aurobindo Pharma Limited | 8000 TABLET in 1 BAG (65862-169-81) | October 31, 2007 |
| 65862-169-99 | 65862-169 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-169-99) | October 31, 2007 |
| 65862-170-01 | 65862-170 | Aurobindo Pharma Limited | 100 TABLET in 1 BOTTLE (65862-170-01) | October 31, 2007 |
| 65862-170-61 | 65862-170 | Aurobindo Pharma Limited | 6000 TABLET in 1 BAG (65862-170-61) | October 31, 2007 |
| 65862-170-99 | 65862-170 | Aurobindo Pharma Limited | 1000 TABLET in 1 BOTTLE (65862-170-99) | October 31, 2007 |
| 71335-0912-1 | 71335-0912 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0912-1) | February 17, 2016 |
| 71335-0912-2 | 71335-0912 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0912-2) | February 17, 2016 |
| 71335-0912-3 | 71335-0912 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0912-3) | February 17, 2016 |
| 71335-0912-4 | 71335-0912 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0912-4) | February 17, 2016 |
| 71335-0912-5 | 71335-0912 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0912-5) | February 17, 2016 |
| 71335-0912-6 | 71335-0912 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0912-6) | February 17, 2016 |
| 71335-0954-1 | 71335-0954 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0954-1) | September 19, 2018 |
| 71335-0954-2 | 71335-0954 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0954-2) | October 26, 2018 |
| 71335-0954-3 | 71335-0954 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0954-3) | August 12, 2021 |
| 71335-0954-4 | 71335-0954 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0954-4) | October 4, 2018 |
| 71335-0954-5 | 71335-0954 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0954-5) | July 23, 2024 |
| 71335-0954-6 | 71335-0954 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-0954-6) | July 23, 2024 |
| 71335-0954-7 | 71335-0954 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-0954-7) | July 23, 2024 |
| 71335-1264-1 | 71335-1264 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1264-1) | January 21, 2021 |
| 71335-1264-2 | 71335-1264 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1264-2) | August 4, 2020 |
| 71335-1264-3 | 71335-1264 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1264-3) | July 9, 2024 |
| 71335-1264-4 | 71335-1264 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1264-4) | July 3, 2019 |
| 71335-1264-5 | 71335-1264 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1264-5) | July 9, 2024 |
| 71335-1264-6 | 71335-1264 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1264-6) | July 9, 2024 |
| 71335-1264-7 | 71335-1264 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1264-7) | July 9, 2024 |
| 71335-1535-1 | 71335-1535 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1535-1) | April 13, 2020 |
| 71335-1535-2 | 71335-1535 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1535-2) | June 9, 2020 |
| 71335-1535-3 | 71335-1535 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1535-3) | March 13, 2020 |
| 71335-1535-4 | 71335-1535 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1535-4) | March 16, 2020 |
| 71335-1535-5 | 71335-1535 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1535-5) | November 4, 2020 |
| 71335-1535-6 | 71335-1535 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1535-6) | April 3, 2024 |
| 71335-1535-7 | 71335-1535 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1535-7) | April 3, 2024 |
| 71335-1616-1 | 71335-1616 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1616-1) | November 16, 2004 |
| 71335-1616-2 | 71335-1616 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1616-2) | November 16, 2004 |
| 71335-1616-3 | 71335-1616 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1616-3) | November 16, 2004 |
| 71335-1616-4 | 71335-1616 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1616-4) | November 16, 2004 |
| 71335-1616-5 | 71335-1616 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-1616-5) | November 16, 2004 |
| 71335-1616-6 | 71335-1616 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-1616-6) | November 16, 2004 |
| 71335-2531-1 | 71335-2531 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2531-1) | November 26, 2024 |
| 71335-2531-2 | 71335-2531 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2531-2) | November 26, 2024 |
| 71335-2531-3 | 71335-2531 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2531-3) | November 26, 2024 |
| 71335-2531-4 | 71335-2531 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2531-4) | November 26, 2024 |
| 71335-2531-5 | 71335-2531 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2531-5) | November 26, 2024 |
| 71335-2531-6 | 71335-2531 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2531-6) | November 26, 2024 |
| 71335-2531-7 | 71335-2531 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2531-7) | November 26, 2024 |
| 71335-2774-1 | 71335-2774 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2774-1) | October 13, 2025 |
| 71335-2774-2 | 71335-2774 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2774-2) | October 13, 2025 |
| 71335-2774-3 | 71335-2774 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2774-3) | October 13, 2025 |
| 71335-2774-4 | 71335-2774 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2774-4) | October 13, 2025 |
| 71335-2774-5 | 71335-2774 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-2774-5) | October 13, 2025 |
| 71335-2774-6 | 71335-2774 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-2774-6) | October 13, 2025 |
| 71335-2774-7 | 71335-2774 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-2774-7) | October 13, 2025 |
| 71335-9611-1 | 71335-9611 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-9611-1) | December 19, 2022 |
| 71335-9611-2 | 71335-9611 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-9611-2) | February 6, 2023 |
| 71335-9611-3 | 71335-9611 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-9611-3) | April 3, 2024 |
| 71335-9611-4 | 71335-9611 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-9611-4) | January 3, 2023 |
| 71335-9611-5 | 71335-9611 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-9611-5) | April 3, 2024 |
| 71335-9611-6 | 71335-9611 | Bryant Ranch Prepack | 180 TABLET in 1 BOTTLE (71335-9611-6) | April 3, 2024 |
| 71335-9611-7 | 71335-9611 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-9611-7) | April 3, 2024 |
| 72162-2324-0 | 72162-2324 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-2324-0) | June 5, 2024 |
| 72162-2324-9 | 72162-2324 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2324-9) | June 5, 2024 |
| 72162-2325-0 | 72162-2325 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-2325-0) | June 5, 2024 |
| 72162-2325-9 | 72162-2325 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2325-9) | June 5, 2024 |
| 72162-2326-0 | 72162-2326 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-2326-0) | June 5, 2024 |
| 72162-2326-9 | 72162-2326 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-2326-9) | June 5, 2024 |
| 55154-0283-0 | 55154-0283 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-0283-0) / 1 TABLET in 1 BLISTER PACK | July 20, 2026 |
| 55154-5455-0 | 55154-5455 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5455-0) / 1 TABLET in 1 BLISTER PACK | June 20, 2011 |
| 55154-5511-0 | 55154-5511 | Cardinal Health 107, LLC | 10 BLISTER PACK in 1 BAG (55154-5511-0) / 1 TABLET in 1 BLISTER PACK | June 20, 2011 |
| 67046-0663-3 | 67046-0663 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0663-3) | April 27, 2026 |
| 67046-0843-3 | 67046-0843 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0843-3) | April 27, 2026 |
| 67046-1076-3 | 67046-1076 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1076-3) | May 6, 2026 |
| 72189-396-30 | 72189-396 | Direct_Rx | 30 TABLET in 1 BOTTLE (72189-396-30) | November 22, 2022 |
| 72189-396-90 | 72189-396 | Direct_Rx | 90 TABLET in 1 BOTTLE (72189-396-90) | November 22, 2022 |
| 60429-025-10 | 60429-025 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (60429-025-10) | February 20, 2014 |
| 60429-025-90 | 60429-025 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (60429-025-90) | February 20, 2014 |
| 60429-026-10 | 60429-026 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (60429-026-10) | February 20, 2014 |
| 60429-026-90 | 60429-026 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (60429-026-90) | February 20, 2014 |
| 60429-027-10 | 60429-027 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (60429-027-10) | February 20, 2014 |
| 60429-027-90 | 60429-027 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (60429-027-90) | February 20, 2014 |
| 83980-022-01 | 83980-022 | Ipca Laboratories Limited | 100 TABLET in 1 BOTTLE (83980-022-01) | January 30, 2026 |
| 83980-022-10 | 83980-022 | Ipca Laboratories Limited | 1000 TABLET in 1 BOTTLE (83980-022-10) | January 30, 2026 |
| 83980-022-97 | 83980-022 | Ipca Laboratories Limited | 10 TABLET in 1 BOTTLE (83980-022-97) | January 30, 2026 |
| 83980-023-01 | 83980-023 | Ipca Laboratories Limited | 100 TABLET in 1 BOTTLE (83980-023-01) | January 30, 2026 |
| 83980-023-10 | 83980-023 | Ipca Laboratories Limited | 1000 TABLET in 1 BOTTLE (83980-023-10) | January 30, 2026 |
| 83980-023-97 | 83980-023 | Ipca Laboratories Limited | 10 TABLET in 1 BOTTLE (83980-023-97) | January 30, 2026 |
| 83980-024-01 | 83980-024 | Ipca Laboratories Limited | 100 TABLET in 1 BOTTLE (83980-024-01) | January 30, 2026 |
| 83980-024-10 | 83980-024 | Ipca Laboratories Limited | 1000 TABLET in 1 BOTTLE (83980-024-10) | January 30, 2026 |
| 83980-024-97 | 83980-024 | Ipca Laboratories Limited | 10 TABLET in 1 BOTTLE (83980-024-97) | January 30, 2026 |
| 0904-7187-61 | 0904-7187 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7187-61) / 1 TABLET in 1 BLISTER PACK | October 31, 2007 |
| 51079-684-20 | 51079-684 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-684-20) / 1 TABLET in 1 BLISTER PACK (51079-684-01) | July 24, 1997 |
| 51079-685-20 | 51079-685 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-685-20) / 1 TABLET in 1 BLISTER PACK (51079-685-01) | July 23, 1997 |
| 51079-759-20 | 51079-759 | Mylan Institutional Inc. | 100 BLISTER PACK in 1 CARTON (51079-759-20) / 1 TABLET in 1 BLISTER PACK (51079-759-01) | June 16, 1999 |
| 0378-0218-01 | 0378-0218 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0218-01) | June 17, 1999 |
| 0378-0218-10 | 0378-0218 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0218-10) | June 17, 1999 |
| 0378-0231-01 | 0378-0231 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0231-01) | January 24, 1992 |
| 0378-0231-10 | 0378-0231 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0231-10) | January 24, 1992 |
| 0378-0757-01 | 0378-0757 | Mylan Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (0378-0757-01) | January 24, 1992 |
| 0378-0757-10 | 0378-0757 | Mylan Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (0378-0757-10) | January 24, 1992 |
| 0615-8372-05 | 0615-8372 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET in 1 BLISTER PACK (0615-8372-05) | January 5, 2021 |
| 0615-8372-39 | 0615-8372 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8372-39) | January 5, 2021 |
| 0615-8373-05 | 0615-8373 | NCS HealthCare of KY, LLC dba Vangard Labs | 15 TABLET in 1 BLISTER PACK (0615-8373-05) | January 5, 2021 |
| 0615-8373-39 | 0615-8373 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8373-39) | January 5, 2021 |
| 51655-104-26 | 51655-104 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-104-26) | September 9, 2022 |
| 51655-104-52 | 51655-104 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-104-52) | October 19, 2023 |
| 51655-491-25 | 51655-491 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (51655-491-25) | December 10, 2020 |
| 51655-533-25 | 51655-533 | Northwind Health Company, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (51655-533-25) | December 28, 2022 |
| 51655-533-26 | 51655-533 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-533-26) | December 28, 2022 |
| 51655-533-52 | 51655-533 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-533-52) | December 28, 2022 |
| 51655-709-26 | 51655-709 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-709-26) | April 8, 2022 |
| 51655-709-52 | 51655-709 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-709-52) | May 7, 2021 |
| 51655-736-26 | 51655-736 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-736-26) | January 28, 2022 |
| 51655-736-52 | 51655-736 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-736-52) | June 17, 2021 |
| 51655-928-26 | 51655-928 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-928-26) | July 6, 2022 |
| 51655-928-52 | 51655-928 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-928-52) | August 10, 2022 |
| 66267-029-30 | 66267-029 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (66267-029-30) | September 26, 2016 |
| 66267-029-60 | 66267-029 | NuCare Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (66267-029-60) | September 26, 2016 |
| 66267-029-90 | 66267-029 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (66267-029-90) | September 26, 2016 |
| 68071-3694-1 | 68071-3694 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3694-1) | October 3, 2024 |
| 68071-3830-1 | 68071-3830 | NuCare Pharmaceuticals,Inc. | 120 TABLET in 1 BOTTLE (68071-3830-1) | April 18, 2025 |
| 68071-3830-9 | 68071-3830 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-3830-9) | November 4, 2025 |
| 68071-3851-3 | 68071-3851 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-3851-3) | October 13, 2025 |
| 68071-3851-6 | 68071-3851 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-3851-6) | October 30, 2025 |
| 68071-3851-9 | 68071-3851 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-3851-9) | September 29, 2025 |
| 68071-4526-3 | 68071-4526 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4526-3) | August 14, 2018 |
| 68071-4526-5 | 68071-4526 | NuCare Pharmaceuticals,Inc. | 45 TABLET in 1 BOTTLE (68071-4526-5) | August 14, 2018 |
| 68071-4526-6 | 68071-4526 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-4526-6) | August 14, 2018 |
| 68071-4526-8 | 68071-4526 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-4526-8) | August 14, 2018 |
| 68071-4526-9 | 68071-4526 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4526-9) | August 14, 2018 |
| 68071-4527-1 | 68071-4527 | NuCare Pharmaceuticals,Inc. | 120 TABLET in 1 BOTTLE (68071-4527-1) | August 14, 2018 |
| 68071-4527-3 | 68071-4527 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4527-3) | August 14, 2018 |
| 68071-4527-6 | 68071-4527 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-4527-6) | August 14, 2018 |
| 68071-4527-9 | 68071-4527 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4527-9) | August 14, 2018 |
| 68071-4538-3 | 68071-4538 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4538-3) | August 23, 2018 |
| 68071-4538-5 | 68071-4538 | NuCare Pharmaceuticals,Inc. | 45 TABLET in 1 BOTTLE (68071-4538-5) | August 23, 2018 |
| 68071-4538-6 | 68071-4538 | NuCare Pharmaceuticals,Inc. | 60 TABLET in 1 BOTTLE (68071-4538-6) | August 23, 2018 |
| 68071-4538-8 | 68071-4538 | NuCare Pharmaceuticals,Inc. | 180 TABLET in 1 BOTTLE (68071-4538-8) | August 23, 2018 |
| 68071-4538-9 | 68071-4538 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4538-9) | August 23, 2018 |
| 68071-4553-1 | 68071-4553 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-4553-1) | September 7, 2018 |
| 68071-4751-9 | 68071-4751 | NuCare Pharmaceuticals,Inc. | 90 TABLET in 1 BOTTLE (68071-4751-9) | February 6, 2025 |
| 68071-5162-1 | 68071-5162 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-5162-1) | February 3, 2020 |
| 43063-765-30 | 43063-765 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-765-30) | May 11, 2017 |
| 43063-765-90 | 43063-765 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-765-90) | December 18, 2017 |
| 43063-805-01 | 43063-805 | PD-Rx Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE, PLASTIC (43063-805-01) | December 1, 2017 |
| 43063-805-30 | 43063-805 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-805-30) | November 28, 2017 |
| 43063-805-90 | 43063-805 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-805-90) | December 13, 2017 |
| 43063-952-30 | 43063-952 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-952-30) | October 18, 2020 |
| 43063-952-90 | 43063-952 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-952-90) | February 28, 2019 |
| 72789-144-30 | 72789-144 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (72789-144-30) | November 11, 2020 |
| 72789-144-90 | 72789-144 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-144-90) | October 30, 2020 |
| 68788-4112-1 | 68788-4112 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-4112-1) | April 22, 2026 |
| 68788-4112-3 | 68788-4112 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-4112-3) | April 22, 2026 |
| 68788-4112-6 | 68788-4112 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-4112-6) | April 22, 2026 |
| 68788-4112-9 | 68788-4112 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-4112-9) | April 22, 2026 |
| 68788-7876-1 | 68788-7876 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7876-1) | March 8, 2021 |
| 68788-7876-3 | 68788-7876 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7876-3) | March 8, 2021 |
| 68788-7876-6 | 68788-7876 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7876-6) | March 8, 2021 |
| 68788-7876-9 | 68788-7876 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7876-9) | March 8, 2021 |
| 68788-8527-1 | 68788-8527 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8527-1) | October 6, 2023 |
| 68788-8527-3 | 68788-8527 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8527-3) | October 6, 2023 |
| 68788-8527-6 | 68788-8527 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8527-6) | October 6, 2023 |
| 68788-8527-9 | 68788-8527 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8527-9) | October 6, 2023 |
| 68788-8739-1 | 68788-8739 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8739-1) | September 20, 2024 |
| 68788-8739-3 | 68788-8739 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8739-3) | September 20, 2024 |
| 68788-8739-6 | 68788-8739 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8739-6) | September 20, 2024 |
| 68788-8739-9 | 68788-8739 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8739-9) | September 20, 2024 |
| 68788-8834-1 | 68788-8834 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8834-1) | February 21, 2025 |
| 68788-8834-3 | 68788-8834 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8834-3) | February 21, 2025 |
| 68788-8834-6 | 68788-8834 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8834-6) | February 21, 2025 |
| 68788-8834-9 | 68788-8834 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8834-9) | February 21, 2025 |
| 68788-7535-1 | 68788-7535 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-7535-1) | October 7, 2019 |
| 68788-7535-3 | 68788-7535 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-7535-3) | October 7, 2019 |
| 68788-7535-6 | 68788-7535 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-7535-6) | October 7, 2019 |
| 68788-7535-9 | 68788-7535 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-7535-9) | October 7, 2019 |
| 68788-7616-1 | 68788-7616 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-7616-1) | February 7, 2020 |
| 68788-7616-3 | 68788-7616 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-7616-3) | February 7, 2020 |
| 68788-7616-6 | 68788-7616 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-7616-6) | February 7, 2020 |
| 68788-7616-9 | 68788-7616 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-7616-9) | February 7, 2020 |
| 63187-537-10 | 63187-537 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (63187-537-10) | September 1, 2016 |
| 63187-537-30 | 63187-537 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-537-30) | January 1, 2015 |
| 63187-537-60 | 63187-537 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-537-60) | January 1, 2015 |
| 63187-537-90 | 63187-537 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-537-90) | January 1, 2016 |
| 63187-710-30 | 63187-710 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-710-30) | June 1, 2016 |
| 63187-710-60 | 63187-710 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-710-60) | June 1, 2016 |
| 63187-710-90 | 63187-710 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-710-90) | June 1, 2016 |
| 71205-096-10 | 71205-096 | Proficient Rx LP | 10 TABLET in 1 BOTTLE (71205-096-10) | August 1, 2018 |
| 71205-096-30 | 71205-096 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-096-30) | August 1, 2018 |
| 71205-096-60 | 71205-096 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-096-60) | August 1, 2018 |
| 71205-096-90 | 71205-096 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-096-90) | August 1, 2018 |
| 71205-229-30 | 71205-229 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-229-30) | March 1, 2019 |
| 71205-229-60 | 71205-229 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-229-60) | March 1, 2019 |
| 71205-229-90 | 71205-229 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-229-90) | March 1, 2019 |
| 71205-496-30 | 71205-496 | Proficient Rx LP | 30 TABLET in 1 BOTTLE, PLASTIC (71205-496-30) | October 23, 2020 |
| 71205-496-60 | 71205-496 | Proficient Rx LP | 60 TABLET in 1 BOTTLE, PLASTIC (71205-496-60) | October 23, 2020 |
| 71205-496-90 | 71205-496 | Proficient Rx LP | 90 TABLET in 1 BOTTLE, PLASTIC (71205-496-90) | October 23, 2020 |
| 42708-162-30 | 42708-162 | QPharma Inc | 30 TABLET in 1 BOTTLE, PLASTIC (42708-162-30) | March 13, 2023 |
| 42708-012-30 | 42708-012 | QPharma, Inc. | 30 TABLET in 1 BOTTLE (42708-012-30) | March 14, 2018 |
| 42708-143-30 | 42708-143 | QPharma, Inc. | 30 TABLET in 1 BOTTLE (42708-143-30) | March 10, 2021 |
| 83008-052-30 | 83008-052 | Quality Care Products, LLC | 30 TABLET in 1 BOTTLE (83008-052-30) | January 25, 2024 |
| 70518-3036-0 | 70518-3036 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3036-0) | March 3, 2021 |
| 70518-3036-1 | 70518-3036 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3036-1) | March 12, 2021 |
| 70518-3531-0 | 70518-3531 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3531-0) | September 21, 2022 |
| 70518-3531-1 | 70518-3531 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3531-1) | October 11, 2022 |
| 70518-3531-2 | 70518-3531 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3531-2) | September 19, 2023 |
| 70518-4099-0 | 70518-4099 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4099-0) | June 12, 2024 |
| 70518-4287-0 | 70518-4287 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4287-0) | February 12, 2025 |
| 64980-437-01 | 64980-437 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-437-01) | June 10, 2010 |
| 64980-437-10 | 64980-437 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-437-10) | June 10, 2010 |
| 64980-438-01 | 64980-438 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-438-01) | June 10, 2010 |
| 64980-438-10 | 64980-438 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-438-10) | June 10, 2010 |
| 64980-439-01 | 64980-439 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-439-01) | June 10, 2010 |
| 64980-439-10 | 64980-439 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-439-10) | June 10, 2010 |
| 48433-004-20 | 48433-004 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-004-20) / 1 TABLET in 1 BLISTER PACK (48433-004-01) | February 3, 2026 |
| 48433-005-20 | 48433-005 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-005-20) / 1 TABLET in 1 BLISTER PACK (48433-005-01) | February 3, 2026 |
| 48433-006-20 | 48433-006 | Safecor Health, LLC | 100 BLISTER PACK in 1 CARTON (48433-006-20) / 1 TABLET in 1 BLISTER PACK (48433-006-01) | February 3, 2026 |
| 60760-642-90 | 60760-642 | St Mary's Medical Park Pharmacy | 90 TABLET in 1 BOTTLE, PLASTIC (60760-642-90) | October 22, 2018 |
| 60760-437-30 | 60760-437 | St. Mary's Medical Park Pharmacy | 30 TABLET in 1 BOTTLE, PLASTIC (60760-437-30) | May 15, 2023 |
| 60760-437-90 | 60760-437 | St. Mary's Medical Park Pharmacy | 90 TABLET in 1 BOTTLE, PLASTIC (60760-437-90) | March 20, 2019 |
| 60760-643-30 | 60760-643 | St. Mary's Medical Park Pharmacy | 30 TABLET in 1 BOTTLE, PLASTIC (60760-643-30) | January 14, 2019 |
| 60760-643-90 | 60760-643 | St. Mary's Medical Park Pharmacy | 90 TABLET in 1 BOTTLE, PLASTIC (60760-643-90) | June 7, 2019 |
| 60760-925-30 | 60760-925 | St. Mary's Medical Park Pharmacy | 30 TABLET in 1 BOTTLE, PLASTIC (60760-925-30) | August 25, 2026 |
| 0093-0752-01 | 0093-0752 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0093-0752-01) | February 22, 1995 |
| 0093-0752-10 | 0093-0752 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (0093-0752-10) | February 22, 1995 |
| 0093-0753-01 | 0093-0753 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0093-0753-01) | February 17, 1995 |
| 0093-0753-05 | 0093-0753 | Teva Pharmaceuticals USA, Inc. | 500 TABLET in 1 BOTTLE (0093-0753-05) | October 23, 2007 |
| 0093-0787-01 | 0093-0787 | Teva Pharmaceuticals USA, Inc. | 100 TABLET in 1 BOTTLE (0093-0787-01) | November 16, 2004 |
| 0093-0787-10 | 0093-0787 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (0093-0787-10) | November 16, 2004 |
| 29300-410-01 | 29300-410 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET in 1 BOTTLE (29300-410-01) | January 6, 2020 |
| 29300-410-05 | 29300-410 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET in 1 BOTTLE (29300-410-05) | January 6, 2020 |
| 29300-410-10 | 29300-410 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE (29300-410-10) | August 26, 2022 |
| 29300-411-01 | 29300-411 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET in 1 BOTTLE (29300-411-01) | January 6, 2020 |
| 29300-411-05 | 29300-411 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET in 1 BOTTLE (29300-411-05) | January 6, 2020 |
| 29300-411-10 | 29300-411 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE (29300-411-10) | August 26, 2022 |
| 29300-412-01 | 29300-412 | Unichem Pharmaceuticals (USA), Inc. | 100 TABLET in 1 BOTTLE (29300-412-01) | January 6, 2020 |
| 29300-412-05 | 29300-412 | Unichem Pharmaceuticals (USA), Inc. | 500 TABLET in 1 BOTTLE (29300-412-05) | January 6, 2020 |
| 29300-412-10 | 29300-412 | Unichem Pharmaceuticals (USA), Inc. | 1000 TABLET in 1 BOTTLE (29300-412-10) | August 26, 2022 |
| 65841-022-01 | 65841-022 | Zydus Lifesciences Limited | 100 TABLET in 1 BOTTLE (65841-022-01) | October 8, 2005 |
| 65841-022-10 | 65841-022 | Zydus Lifesciences Limited | 1000 TABLET in 1 BOTTLE (65841-022-10) | October 8, 2005 |
| 65841-022-16 | 65841-022 | Zydus Lifesciences Limited | 90 TABLET in 1 BOTTLE (65841-022-16) | October 8, 2005 |
| 65841-022-24 | 65841-022 | Zydus Lifesciences Limited | 10000 TABLET in 1 BOTTLE (65841-022-24) | October 8, 2005 |
| 65841-022-40 | 65841-022 | Zydus Lifesciences Limited | 5000 TABLET in 1 BOTTLE (65841-022-40) | October 8, 2005 |
| 65841-023-01 | 65841-023 | Zydus Lifesciences Limited | 100 TABLET in 1 BOTTLE (65841-023-01) | October 8, 2005 |
| 65841-023-02 | 65841-023 | Zydus Lifesciences Limited | 2000 TABLET in 1 BOTTLE (65841-023-02) | October 8, 2005 |
| 65841-023-10 | 65841-023 | Zydus Lifesciences Limited | 1000 TABLET in 1 BOTTLE (65841-023-10) | October 8, 2005 |
| 65841-023-16 | 65841-023 | Zydus Lifesciences Limited | 90 TABLET in 1 BOTTLE (65841-023-16) | October 8, 2005 |
| 65841-023-24 | 65841-023 | Zydus Lifesciences Limited | 10000 TABLET in 1 BOTTLE (65841-023-24) | October 8, 2005 |
| 65841-023-40 | 65841-023 | Zydus Lifesciences Limited | 5000 TABLET in 1 BOTTLE (65841-023-40) | October 8, 2005 |
| 65841-024-01 | 65841-024 | Zydus Lifesciences Limited | 100 TABLET in 1 BOTTLE (65841-024-01) | October 8, 2005 |
| 65841-024-10 | 65841-024 | Zydus Lifesciences Limited | 1000 TABLET in 1 BOTTLE (65841-024-10) | October 8, 2005 |
| 65841-024-16 | 65841-024 | Zydus Lifesciences Limited | 90 TABLET in 1 BOTTLE (65841-024-16) | October 8, 2005 |
| 65841-024-40 | 65841-024 | Zydus Lifesciences Limited | 5000 TABLET in 1 BOTTLE (65841-024-40) | October 8, 2005 |
| 68382-022-01 | 68382-022 | Zydus Pharmaceuticals USA Inc. | 100 TABLET in 1 BOTTLE (68382-022-01) | October 8, 2005 |
| 68382-022-10 | 68382-022 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET in 1 BOTTLE (68382-022-10) | October 8, 2005 |
| 68382-022-16 | 68382-022 | Zydus Pharmaceuticals USA Inc. | 90 TABLET in 1 BOTTLE (68382-022-16) | October 8, 2005 |
| 68382-022-24 | 68382-022 | Zydus Pharmaceuticals USA Inc. | 10000 TABLET in 1 BOTTLE (68382-022-24) | October 8, 2005 |
| 68382-022-40 | 68382-022 | Zydus Pharmaceuticals USA Inc. | 5000 TABLET in 1 BOTTLE (68382-022-40) | October 8, 2005 |
| 68382-023-01 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 100 TABLET in 1 BOTTLE (68382-023-01) | October 8, 2005 |
| 68382-023-02 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 2000 TABLET in 1 BOTTLE (68382-023-02) | October 8, 2005 |
| 68382-023-10 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET in 1 BOTTLE (68382-023-10) | October 8, 2005 |
| 68382-023-16 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 90 TABLET in 1 BOTTLE (68382-023-16) | October 8, 2005 |
| 68382-023-24 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 10000 TABLET in 1 BOTTLE (68382-023-24) | October 8, 2005 |
| 68382-023-40 | 68382-023 | Zydus Pharmaceuticals USA Inc. | 5000 TABLET in 1 BOTTLE (68382-023-40) | October 8, 2005 |
| 68382-024-01 | 68382-024 | Zydus Pharmaceuticals USA Inc. | 100 TABLET in 1 BOTTLE (68382-024-01) | October 8, 2005 |
| 68382-024-10 | 68382-024 | Zydus Pharmaceuticals USA Inc. | 1000 TABLET in 1 BOTTLE (68382-024-10) | October 8, 2005 |
| 68382-024-16 | 68382-024 | Zydus Pharmaceuticals USA Inc. | 90 TABLET in 1 BOTTLE (68382-024-16) | October 8, 2005 |
| 68382-024-40 | 68382-024 | Zydus Pharmaceuticals USA Inc. | 5000 TABLET in 1 BOTTLE (68382-024-40) | October 8, 2005 |
| 72189-135-30 | 72189-135 | direct rx | 30 TABLET in 1 BOTTLE (72189-135-30) | December 2, 2020 |
| 72189-135-90 | 72189-135 | direct rx | 90 TABLET in 1 BOTTLE (72189-135-90) | December 2, 2020 |
| 72189-146-30 | 72189-146 | direct rx | 30 TABLET in 1 BOTTLE (72189-146-30) | January 25, 2022 |
| 72189-146-60 | 72189-146 | direct rx | 60 TABLET in 1 BOTTLE (72189-146-60) | January 25, 2022 |
| 72189-146-90 | 72189-146 | direct rx | 90 TABLET in 1 BOTTLE (72189-146-90) | January 25, 2022 |
| 72189-152-30 | 72189-152 | direct rx | 30 TABLET in 1 BOTTLE (72189-152-30) | November 10, 2020 |
| 72189-152-90 | 72189-152 | direct rx | 90 TABLET in 1 BOTTLE (72189-152-90) | November 10, 2020 |
| 50090-0442 | 50090-0442 | A-S Medication Solutions | — | October 8, 2005 |
| 50090-3411 | 50090-3411 | A-S Medication Solutions | — | November 16, 2004 |
| 50090-5363 | 50090-5363 | A-S Medication Solutions | — | November 21, 2019 |
| 50090-5367 | 50090-5367 | A-S Medication Solutions | — | June 10, 2010 |
| 50090-5738 | 50090-5738 | A-S Medication Solutions | — | October 31, 2007 |
| 50090-5741 | 50090-5741 | A-S Medication Solutions | — | October 31, 2007 |
| 50090-6241 | 50090-6241 | A-S Medication Solutions | — | November 21, 2019 |
| 50090-6311 | 50090-6311 | A-S Medication Solutions | — | November 21, 2019 |
| 50090-6779 | 50090-6779 | A-S Medication Solutions | — | October 8, 2005 |
| 50090-6935 | 50090-6935 | A-S Medication Solutions | — | November 16, 2004 |
| 50090-7561 | 50090-7561 | A-S Medication Solutions | — | November 21, 2019 |
| 50090-7603 | 50090-7603 | A-S Medication Solutions | — | November 21, 2019 |
| 50090-7847 | 50090-7847 | A-S Medication Solutions | — | June 10, 2010 |
| 50090-8048 | 50090-8048 | A-S Medication Solutions | — | December 4, 2007 |
| 87063-177 | 87063-177 | ASCLEMED USA INC. | — | November 21, 2019 |
| 87063-178 | 87063-178 | ASCLEMED USA INC. | — | November 21, 2019 |
| 87063-179 | 87063-179 | ASCLEMED USA INC. | — | November 21, 2019 |
| 60687-605 | 60687-605 | American Health Packaging | — | October 25, 2021 |
| 43353-834 | 43353-834 | Aphena Pharma Solutions - Tennessee, LLC | — | February 20, 2014 |
| 43353-986 | 43353-986 | Aphena Pharma Solutions - Tennessee, LLC | — | February 20, 2014 |
| 71610-658 | 71610-658 | Aphena Pharma Solutions - Tennessee, LLC | — | April 26, 1999 |
| 71610-857 | 71610-857 | Aphena Pharma Solutions - Tennessee, LLC | — | November 16, 2004 |
| 71610-861 | 71610-861 | Aphena Pharma Solutions - Tennessee, LLC | — | February 22, 1995 |
| 65862-168 | 65862-168 | Aurobindo Pharma Limited | — | October 31, 2007 |
| 65862-169 | 65862-169 | Aurobindo Pharma Limited | — | October 31, 2007 |
| 65862-170 | 65862-170 | Aurobindo Pharma Limited | — | October 31, 2007 |
| 71335-0912 | 71335-0912 | Bryant Ranch Prepack | — | October 8, 2005 |
| 71335-0954 | 71335-0954 | Bryant Ranch Prepack | — | June 10, 2010 |
| 71335-1264 | 71335-1264 | Bryant Ranch Prepack | — | June 10, 2010 |
| 71335-1535 | 71335-1535 | Bryant Ranch Prepack | — | June 10, 2010 |
| 71335-1616 | 71335-1616 | Bryant Ranch Prepack | — | November 16, 2004 |
| 71335-2531 | 71335-2531 | Bryant Ranch Prepack | — | October 31, 2007 |
| 71335-2774 | 71335-2774 | Bryant Ranch Prepack | — | November 21, 2019 |
| 71335-9611 | 71335-9611 | Bryant Ranch Prepack | — | November 21, 2019 |
| 72162-2324 | 72162-2324 | Bryant Ranch Prepack | — | December 19, 2022 |
| 72162-2325 | 72162-2325 | Bryant Ranch Prepack | — | December 19, 2022 |
| 72162-2326 | 72162-2326 | Bryant Ranch Prepack | — | December 19, 2022 |
| 55154-0283 | 55154-0283 | Cardinal Health 107, LLC | — | July 20, 2026 |
| 55154-5455 | 55154-5455 | Cardinal Health 107, LLC | — | June 20, 2011 |
| 55154-5511 | 55154-5511 | Cardinal Health 107, LLC | — | June 20, 2011 |
| 67046-0663 | 67046-0663 | Coupler LLC | — | April 27, 2026 |
| 67046-0843 | 67046-0843 | Coupler LLC | — | April 27, 2026 |
| 67046-1076 | 67046-1076 | Coupler LLC | — | May 6, 2026 |
| 72189-396 | 72189-396 | Direct_Rx | — | November 22, 2022 |
| 60429-025 | 60429-025 | Golden State Medical Supply, Inc. | — | January 24, 1992 |
| 60429-026 | 60429-026 | Golden State Medical Supply, Inc. | — | January 24, 1992 |
| 60429-027 | 60429-027 | Golden State Medical Supply, Inc. | — | April 26, 1999 |
| 83980-022 | 83980-022 | Ipca Laboratories Limited | — | December 4, 2007 |
| 83980-023 | 83980-023 | Ipca Laboratories Limited | — | December 4, 2007 |
| 83980-024 | 83980-024 | Ipca Laboratories Limited | — | December 4, 2007 |
| 0904-7187 | 0904-7187 | Major Pharmaceuticals | — | October 31, 2007 |
| 51079-684 | 51079-684 | Mylan Institutional Inc. | — | July 24, 1997 |
| 51079-685 | 51079-685 | Mylan Institutional Inc. | — | July 23, 1997 |
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 |
| Enforcement | FDA | Recall records |
Generated September 25, 2026 · 12 sections on this page.