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Enalapril Maleate
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 |
|---|---|---|
| Angiotensin Converting Enzyme Inhibitor [EPC] | EPC | All 34 members |
| Angiotensin-converting Enzyme Inhibitors [MoA] | MoA | All 34 members |
| Decreased Blood Pressure [PE] | PE | All 21 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 213273-001 | ENALAPRIL MALEATE | TABLET | ENALAPRIL MALEATE | Prescription | AB | ||
| 213273-002 | ENALAPRIL MALEATE | TABLET | ENALAPRIL MALEATE | Prescription | AB | ||
| 213273-003 | ENALAPRIL MALEATE | TABLET | ENALAPRIL MALEATE | Prescription | AB | ||
| 213273-004 | ENALAPRIL MALEATE | TABLET | ENALAPRIL MALEATE | 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 |
|---|---|---|---|---|---|
| Original application | 1 | Approved | July 7, 2022 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260410). This is the manufacturer's labelling text, not a summary and not advice.
Boxed Warning
openFDA Drug LabelingWARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. • When pregnancy is detected, discontinue enalapril maleate tablets as soon as possible. • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. (See Error! Hyperlink reference not valid..)
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Hypertension Enalapril maleate tablets, USP are indicated for the treatment of hypertension. Enalapril maleate tablets, USP are effective alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. The blood pressure lowering effects of enalapril maleate tablets, USP and thiazides are approximately additive. Heart Failure Enalapril maleate tablets, USP are indicated for the treatment of symptomatic congestive heart failure, usually in combination with diuretics and digitalis. In these patients enalapril maleate tablets, USP improve symptoms, increase survival, and decrease the frequency of hospitalization (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). Asymptomatic Left Ventricular Dysfunction In clinically stable asymptomatic patients with left ventricular dysfunction (ejection fraction ≤35 percent), enalapril maleate tablets, USP decrease the rate of development of overt heart failure and decrease the incidence of hospitalization for heart failure (see CLINICAL PHARMACOLOGY, Heart Failure, Mortality Trials for details and limitations of survival trials). In using enalapril maleate tablets, USP consideration should be given to the fact that another angiotensin-converting enzyme inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen vascular disease, and that available data are insufficient to show that enalapril maleate tablets, USP do not have a similar risk (see WARNINGS, Neutropenia/Agranulocytosis ). In considering use of enalapril maleate tablets, USP, it should be noted that in controlled clinical trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, it should be noted that black patients receiving ACE inhibitors have been reported to have a higher incidence of angioedema compared to nonblacks (see WARNINGS, Head and Neck Angioedema ).
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION Hypertension In patients who are currently being treated with a diuretic, symptomatic hypotension occasionally may occur following the initial dose of enalapril maleate tablets. The diuretic should, if possible, be discontinued for two to three days before beginning therapy with enalapril maleate tablets to reduce the likelihood of hypotension (see WARNINGS, Hypotension ). If the patient's blood pressure is not controlled with enalapril maleate tablets alone, diuretic therapy may be resumed. If the diuretic cannot be discontinued an initial dose of 2.5 mg should be used under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS, Hypotension and PRECAUTIONS, Drug Interactions ). The recommended initial dose in patients not on diuretics is 5 mg once a day. Dosage should be adjusted according to blood pressure response. The usual dosage range is 10 to 40 mg per day administered in a single dose or two divided doses. In some patients treated once daily, the antihypertensive effect may diminish toward the end of the dosing interval. In such patients, an increase in dosage or twice daily administration should be considered. If blood pressure is not controlled with enalapril maleate tablets alone, a diuretic may be added. Concomitant administration of enalapril maleate tablets with potassium supplements, potassium salt substitutes, or potassium-sparing diuretics may lead to increases of serum potassium (see PRECAUTIONS ). Dosage Adjustment in Hypertensive Patients with Renal Impairment The usual dose of enalapril is recommended for patients with a creatinine clearance more than 30 mL/min (serum creatinine of up to approximately 3 mg/dL). For patients with creatinine clearance less than or equal to 30 mL/min (serum creatinine more than or equal to 3 mg/dL), the first dose is 2.5 mg once daily. The dosage may be titrated upward until blood pressure is controlled or to a maximum of 40 mg daily. Renal Status Creatinine Clearance mL/min Initial Dose mg/day Normal Renal Function >80 mL/min 5 mg Mild Impairment ≤ 80 >30 mL/min 5 mg Moderate to Severe Impairment ≤30 mL/min 2.5 mg Dialysis Patients See Error! Hyperlink reference not valid. . 2.5 mg on dialysis days Dosage on nondialysis days should be adjusted depending on the blood pressure response. Heart Failure Enalapril maleate tablets are indicated for the treatment of symptomatic heart failure, usually in combination with diuretics and digitalis. In the placebo-controlled studies that demonstrated improved survival, patients were titrated as tolerated up to 40 mg, administered in two divided doses. The recommended initial dose is 2.5 mg. The recommended dosing range is 2.5 to 20 mg given twice a day. Doses should be titrated upward, as tolerated, over a period of a few days or weeks. The maximum daily dose administered in clinical trials was 40 mg in divided doses. After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactions ). If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension. The appearance of hypotension after the initial dose of enalapril maleate tablets does not preclude subsequent careful dose titration with the drug, following effective management of the hypotension. Asymptomatic Left Ventricular Dysfunction In the trial that demonstrated efficacy, patients were started on 2.5 mg twice daily and were titrated as tolerated to the targeted daily dose of 20 mg (in divided doses). After the initial dose of enalapril maleate tablets, the patient should be observed under medical supervision for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS and PRECAUTIONS, Drug Interactio …
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Enalapril maleate tablets, USP are contraindicated in patients who are hypersensitive to this product and in patients with a history of angioedema related to previous treatment with an angiotensin-converting enzyme inhibitor and in patients with hereditary or idiopathic angioedema. Do not coadminister aliskiren with enalapril maleate in patients with diabetes (see PRECAUTIONS, Drug Interactions ). Enalapril maleate tablets, USP are contraindicated in combination with a neprilysin inhibitor (e.g., sacubitril). Do not administer enalapril maleate tablets USP within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor (see WARNINGS , Head and Neck Angioedema ).
Warnings
openFDA Drug LabelingWARNINGS Anaphylactoid and Possibly Related Reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including Enalapril Maleate Tablets) may be subject to a variety of adverse reactions, some of them serious. Head and Neck Angioedema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients treated with angiotensin-converting enzyme inhibitors, including Enalapril Maleate Tablets. This may occur at any time during treatment. In such cases Enalapril Maleate Tablets should be promptly discontinued and appropriate therapy and monitoring should be provided until complete and sustained resolution of signs and symptoms has occurred. In instances where swelling has been confined to the face and lips the condition has generally resolved without treatment, although antihistamines have been useful in relieving symptoms. Angioedema associated with laryngeal edema may be fatal. Where there is involvement of the tongue, glottis or larynx, likely to cause airway obstruction, appropriate therapy, e.g., subcutaneous epinephrine solution 1:1000 (0.3 mL to 0.5 mL) and/or measures necessary to ensure a patent airway, should be promptly provided (see ADVERSE REACTIONS ). Patients receiving coadministration of ACE inhibitor and mTOR (mammalian target of rapamycin) inhibitor (e.g., temsirolimus, sirolimus, everolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema (see PRECAUTIONS ). Intestinal Angioedema : Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C1 esterase levels were normal. The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE inhibitor. Intestinal angioedema should be included in the differential diagnosis of patients on ACE inhibitors presenting with abdominal pain. Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (see INDICATIONS AND USAGE and CONTRAINDICATIONS ). Anaphylactoid Reactions During Desensitization Two patients undergoing desensitizing treatment with hymenoptera venom while receiving ACE inhibitors sustained life-threatening anaphylactoid reactions. In the same patients, these reactions were avoided when ACE inhibitors were temporarily withheld, but they reappeared upon inadvertent rechallenge. Anaphylactoid Reactions During Membrane Exposure Anaphylactoid reactions have been reported in patients dialyzed with high-flux membranes and treated concomitantly with an ACE inhibitor. Anaphylactoid reactions have also been reported in patients undergoing low-density lipoprotein apheresis with dextran sulfate absorption. Hypotension Excessive hypotension is rare in uncomplicated hypertensive patients treated with Enalapril Maleate Tablets alone. Patients with heart failure given Enalapril Maleate Tablets commonly have some reduction in blood pressure, especially with the first dose, but discontinuation of therapy for continuing symptomatic hypotension usually is not necessary when dosing instructions are followed; caution should be observed when initiating therapy (see DOSAGE AND ADMINISTRATION ). Patients at risk for excessive hypotension, sometimes associated with oliguria and/or progressive azotemia, and rarely with acute renal failure and/or death, include those with the following conditions or characteristics: heart failure, hyponatremia, high-dose diuretic therapy, recent intensive diuresis or increase in diuretic dose, renal dialysis, or severe volume and/or salt depletion of any etiology. It may be advisable to eliminate the diuretic (except in patients …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Enalapril maleate tablets have been evaluated for safety in more than 10,000 patients, including over 1000 patients treated for one year or more. Enalapril maleate tablets have been found to be generally well tolerated in controlled clinical trials involving 2987 patients. For the most part, adverse experiences were mild and transient in nature. In clinical trials, discontinuation of therapy due to clinical adverse experiences was required in 3.3 percent of patients with hypertension and in 5.7 percent of patients with heart failure. The frequency of adverse experiences was not related to total daily dosage within the usual dosage ranges. In patients with hypertension the overall percentage of patients treated with enalapril maleate tablets reporting adverse experiences was comparable to placebo. Hypertension Adverse experiences occurring in greater than one percent of patients with hypertension treated with enalapril maleate tablets in controlled clinical trials are shown below. In patients treated with enalapril maleate tablets, the maximum duration of therapy was three years; in placebo-treated patients the maximum duration of therapy was 12 weeks. Enalapril Maleate Tablets (n=2314) Incidence (discontinuation) Placebo (n=230) Incidence Body As A Whole Fatigue 3.0 (<0.1) 2.6 Orthostatic Effects 1.2 (<0.1) 0.0 Asthenia 1.1 (0.1) 0.9 Digestive Diarrhea 1.4 (<0.1) 1.7 Nausea 1.4 (0.2) 1.7 Nervous/Psychiatric Headache 5.2 (0.3) 9.1 Dizziness 4.3 (0.4) 4.3 Respiratory Cough 1.3 (0.1) 0.9 Skin Rash 1.4 (0.4) 0.4 Heart Failure Adverse experiences occurring in greater than one percent of patients with heart failure treated with enalapril maleate tablets are shown below. The incidences represent the experiences from both controlled and uncontrolled clinical trials (maximum duration of therapy was approximately one year). In the placebo-treated patients, the incidences reported are from the controlled trials (maximum duration of therapy is 12 weeks). The percentage of patients with severe heart failure (NYHA Class IV) was 29 percent and 43 percent for patients treated with enalapril maleate tablets and placebo, respectively. Enalapril Maleate Tablets (n=673) Incidence (discontinuation) Placebo (n=339) Incidence Body As A Whole Orthostatic Effects 2.2 (0.1) 0.3 Syncope 2.2 (0.1) 0.9 Chest Pain 2.1 (0.0) 2.1 Fatigue 1.8 (0.0) 1.8 Abdominal Pain 1.6 (0.4) 2.1 Asthenia 1.6 (0.1) 0.3 Cardiovascular Hypotension 6.7 (1.9) 0.6 Orthostatic Hypotension 1.6 (0.1) 0.3 Angina Pectoris 1.5 (0.1) 1.8 Myocardial Infarction 1.2 (0.3) 1.8 Digestive Diarrhea 2.1 (0.1) 1.2 Nausea 1.3 (0.1) 0.6 Vomiting 1.3 (0.0) 0.9 Nervous/Psychiatric Dizziness 7.9 (0.6) 0.6 Headache 1.8 (0.1) 0.9 Vertigo 1.6 (0.1) 1.2 Respiratory Cough 2.2 (0.0) 0.6 Bronchitis 1.3 (0.0) 0.9 Dyspnea 1.3 (0.1) 0.4 Pneumonia 1.0 (0.0) 2.4 Skin Rash 1.3 (0.0) 2.4 Urogenital Urinary Tract Infection 1.3 (0.0) 2.4 Other serious clinical adverse experiences occurring since the drug was marketed or adverse experiences occurring in 0.5 to 1.0 percent of patients with hypertension or heart failure in clinical trials are listed below and, within each category, are in order of decreasing severity. Body As A Whole: Anaphylactoid reactions (see Error! Hyperlink reference not valid. ). Cardiovascular: Cardiac arrest; myocardial infarction or cerebrovascular accident, possibly secondary to excessive hypotension in high risk patients (see WARNINGS, Hypotension ); pulmonary embolism and infarction; pulmonary edema; rhythm disturbances including atrial tachycardia and bradycardia; atrial fibrillation; palpitation, Raynaud's phenomenon. Digestive: Ileus, pancreatitis, hepatic failure, hepatitis (hepatocellular [proven on rechallenge] or cholestatic jaundice) (see Error! Hyperlink reference not valid. ), melena, anorexia, dyspepsia, constipation, glossitis, stomatitis, dry mouth. Hematologic: Rare cases of neutropenia, thrombocytopenia and bone marrow depression. Musculoskeletal: Muscle cr …
Drug Interactions
openFDA Drug LabelingDrug Interactions Neprilysin Inhibitors Patients taking concomitant neprilysin inhibitors may be at increased risk for angioedema (see WARNINGS ). Dual Blockade of the Renin-Angiotensin System (RAS) Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors. Closely monitor blood pressure, renal function, and electrolytes in patients on enalapril maleate tablets and other agents that affect the RAS. Do not coadminister aliskiren with enalapril maleate tablets in patients with diabetes. Avoid use of aliskiren with enalapril maleate tablets in patients with renal impairment (GFR <60 mL/min). Hypotension — Patients on Diuretic Therapy Patients on diuretics and especially those in whom diuretic therapy was recently instituted, may occasionally experience an excessive reduction of blood pressure after initiation of therapy with enalapril. The possibility of hypotensive effects with enalapril can be minimized by either discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with enalapril. If it is necessary to continue the diuretic, provide close medical supervision after the initial dose for at least two hours and until blood pressure has stabilized for at least an additional hour (see WARNINGS, Hypotension and DOSAGE AND ADMINISTRATION ). Agents Causing Renin Release The antihypertensive effect of enalapril maleate tablets is augmented by antihypertensive agents that cause renin release (e.g., diuretics). Nonsteroidal Anti-Inflammatory Agents Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors) In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, coadministration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including enalapril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving enalapril and NSAID therapy. In a clinical pharmacology study, indomethacin or sulindac was administered to hypertensive patients receiving enalapril maleate tablets. In this study there was no evidence of a blunting of the antihypertensive action of enalapril maleate tablets. However, reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. Other Cardiovascular Agents Enalapril maleate tablets have been used concomitantly with beta adrenergic-blocking agents, methyldopa, nitrates, calcium-blocking agents, hydralazine, prazosin and digoxin without evidence of clinically significant adverse interactions. Agents Increasing Serum Potassium Enalapril maleate tablets attenuate potassium loss caused by thiazide-type diuretics. Potassium-sparing diuretics (e.g., spironolactone, triamterene, or amiloride), potassium supplements, or potassium-containing salt substitutes may lead to significant increases in serum potassium. Therefore, if concomitant use of these agents is indicated because of demonstrated hypokalemia, they should be used with caution and with frequent monitoring of serum potassium. Potassium-sparing agents should generally not be used in patients with heart failure receiving enalapril maleate tablets. Lithium Lithium toxicity has been reported in patients receiving lithium concomitantly with drugs which cause elimination of sodium, including ACE inhibitors. A few cases of lithium toxicity have been reported in patients receiving concomitant enalapril maleate tablets and lithium and were reversible upon discontinuation of both drugs. It is recommended that serum lithium levels be monitored frequently if …
Mechanism of Action
openFDA Drug LabelingMechanism of Action Enalapril, after hydrolysis to enalaprilat, inhibits angiotensin-converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. The beneficial effects of enalapril in hypertension and heart failure appear to result primarily from suppression of the renin-angiotensin-aldosterone system. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasopressor activity and to decreased aldosterone secretion. Although the latter decrease is small, it results in small increases of serum potassium. In hypertensive patients treated with enalapril maleate tablets alone for up to 48 weeks, mean increases in serum potassium of approximately 0.2 mEq/L were observed. In patients treated with enalapril maleate tablets plus a thiazide diuretic, there was essentially no change in serum potassium (see PRECAUTIONS ). Removal of angiotensin II negative feedback on renin secretion leads to increased plasma renin activity. ACE is identical to kininase, an enzyme that degrades bradykinin. Whether increased levels of bradykinin, a potent vasodepressor peptide, play a role in the therapeutic effects of enalapril maleate tablets remains to be elucidated. While the mechanism through which enalapril maleate tablets lower blood pressure is believed to be primarily suppression of the renin-angiotensin-aldosterone system, enalapril maleate tablets are antihypertensive even in patients with low-renin hypertension. Although enalapril maleate tablets were antihypertensive in all races studied, black hypertensive patients (usually a low-renin hypertensive population) had a smaller average response to enalapril monotherapy than non-black patients.
Description
openFDA Drug LabelingDESCRIPTION Enalapril maleate, USP is the maleate salt of enalapril, the ethyl ester of a long-acting angiotensin-converting enzyme inhibitor, enalaprilat. Enalapril maleate is chemically described as L–Proline, 1–[N-[1-(ethoxycarbonyl)–3–phenylpropyl]–L–alanyl]-,(S)-,(Z)-2-butenedioate(1:1). Its empirical formula is C 20 H 28 N 2 O 5 ●C 4 H 4 O 4 , and its structural formula is: Enalapril maleate, USP is an off-white, crystalline powder with a molecular weight of 492.52. It is practically insoluble in n-Heptane (non-polar organic solvents), slightly soluble in Acetone (semi polar organic solvents), sparingly soluble in water, soluble in alcohol, freely soluble in methanol and in dimethyl formamide. Enalapril is a pro-drug; following oral administration, it is bioactivated by hydrolysis of the ethyl ester to enalaprilat, which is the active angiotensin-converting enzyme inhibitor. Enalapril maleate, USP is supplied as 2.5 mg, 5 mg, 10 mg, and 20 mg tablets for oral administration. In addition to the active ingredient enalapril maleate, USP each tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol 4000, pregelatinised starch, sodium bicarbonate and sodium stearate. The 10 mg tablets also contain red iron oxide, and 20 mg tablets also contain yellow iron oxide and red iron oxide. FDA approved dissolution test specifications differs from the USP. enalapril-maleate-stru
Overdosage
openFDA Drug LabelingOVERDOSAGE Limited data are available in regard to overdosage in humans. Single oral doses of enalapril above 1,000 mg/kg and ≥1,775 mg/kg were associated with lethality in mice and rats, respectively. The most likely manifestation of overdosage would be hypotension, for which the usual treatment would be intravenous infusion of normal saline solution. Enalaprilat may be removed from general circulation by hemodialysis and has been removed from neonatal circulation by peritoneal dialysis (see WARNINGS , Anaphylactoid Reactions During Membrane Exposure ).
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Enalapril Maleate Tablets, USP NDC Number Strength Quantity Description 43547-545-03 2.5 mg Bottles of 30 with child-resistant closure (with desiccant) White, oval shaped scored tablet, debossed with “S 1” and scored on one side, “S” and “1” are separated by the score and plain on the other side. 43547-545-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-545-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-545-50 Bottles of 500 with child-resistant closure (with desiccant) 43547-545-11 Bottles of 1,000 (with desiccant) 43547-546-03 5 mg Bottles of 30 with child-resistant closure (with desiccant) White, rounded triangle shaped scored tablet debossed with “S 6” on one side and scored on the other side. 43547-546-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-546-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-546-50 Bottles of 500 (with desiccant) 43547-546-11 Bottles of 1,000 (with desiccant) 43547-547-03 10 mg Bottles of 30 with child-resistant closure (with desiccant) Red, rounded triangle shaped scored tablet debossed with “S 7” on one side and scored on the other side. 43547-547-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-547-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-547-50 Bottles of 500 (with desiccant) 43547-547-11 Bottles of 1,000 (with desiccant) 43547-548-03 20 mg Bottles of 30 with child-resistant closure (with desiccant) Yellow, round scored tablet, debossed with “S 11” and scored on one side, “S 11” is on one side of the score and plain on the other side. 43547-548-09 Bottles of 90 with child-resistant closure (with desiccant) 43547-548-10 Bottles of 100 with child-resistant closure (with desiccant) 43547-548-50 Bottles of 500 (with desiccant) 43547-548-11 Bottles of 1,000 (with desiccant) Storage Store at 20 o to 25 o C (68 o to 77 o F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from moisture. Dispense in a tight container as per USP, if product package is subdivided. Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xunqiao, Linhai, Zhejiang 317024, China Zhejiang Huahai Pharmaceutical Technology Co., Ltd. Jiangnan, Linhai, Zhejiang 317000, China Distributed by: Solco Healthcare US, LLC Somerset, NJ 08873, USA Revised: 01/2026
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: ENALAPRIL MALEATE. 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 II | May 13, 2026 | JB Chemicals and Pharmaceuticals Ltd | Failed Impurities/Degradation Specifications:Out of specification result occurred in Organic Impurities Test | Ongoing |
| Class II | July 13, 2022 | Golden State Medical Supply Inc. | CGMP Deviations | Ongoing |
| Class II | July 13, 2022 | Golden State Medical Supply Inc. | CGMP Deviations | Ongoing |
| Class II | July 13, 2022 | Golden State Medical Supply Inc. | CGMP Deviations | Ongoing |
| Class II | July 13, 2022 | Golden State Medical Supply Inc. | CGMP Deviations | Ongoing |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-3378-0 | 50090-3378 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE, PLASTIC (50090-3378-0) | November 28, 2014 |
| 50090-3378-1 | 50090-3378 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-3378-1) | February 22, 2018 |
| 50090-3378-3 | 50090-3378 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3378-3) | November 19, 2022 |
| 50090-4560-0 | 50090-4560 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-4560-0) | September 26, 2019 |
| 50090-4560-1 | 50090-4560 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-4560-1) | September 26, 2019 |
| 50090-4560-3 | 50090-4560 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-4560-3) | September 26, 2019 |
| 50090-6437-0 | 50090-6437 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6437-0) | April 14, 2023 |
| 50090-6437-1 | 50090-6437 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-6437-1) | April 26, 2023 |
| 50090-6437-3 | 50090-6437 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6437-3) | April 26, 2023 |
| 50090-6490-0 | 50090-6490 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6490-0) | May 18, 2023 |
| 50090-6490-1 | 50090-6490 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6490-1) | May 18, 2023 |
| 50090-6490-3 | 50090-6490 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6490-3) | May 18, 2023 |
| 50090-6712-0 | 50090-6712 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-6712-0) | September 28, 2023 |
| 50090-6712-1 | 50090-6712 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-6712-1) | September 28, 2023 |
| 50090-6712-4 | 50090-6712 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-6712-4) | September 28, 2023 |
| 50090-7222-0 | 50090-7222 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7222-0) | August 13, 2024 |
| 50090-7222-1 | 50090-7222 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7222-1) | August 13, 2024 |
| 50090-7222-3 | 50090-7222 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7222-3) | August 13, 2024 |
| 50090-7302-0 | 50090-7302 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7302-0) | October 14, 2024 |
| 50090-7302-1 | 50090-7302 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7302-1) | October 14, 2024 |
| 50090-7302-3 | 50090-7302 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7302-3) | October 14, 2024 |
| 50090-7677-0 | 50090-7677 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7677-0) | October 8, 2025 |
| 50090-7677-1 | 50090-7677 | A-S Medication Solutions | 60 TABLET in 1 BOTTLE (50090-7677-1) | October 8, 2025 |
| 50090-7677-3 | 50090-7677 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7677-3) | October 8, 2025 |
| 50090-7678-0 | 50090-7678 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-7678-0) | October 8, 2025 |
| 50090-7678-1 | 50090-7678 | A-S Medication Solutions | 100 TABLET in 1 BOTTLE (50090-7678-1) | October 8, 2025 |
| 50090-7678-4 | 50090-7678 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-7678-4) | October 8, 2025 |
| 69292-540-01 | 69292-540 | Amici Pharma, Inc | 100 TABLET in 1 BOTTLE (69292-540-01) | October 15, 2025 |
| 69292-540-10 | 69292-540 | Amici Pharma, Inc | 1000 TABLET in 1 BOTTLE (69292-540-10) | October 15, 2025 |
| 69292-542-01 | 69292-542 | Amici Pharma, Inc | 100 TABLET in 1 BOTTLE (69292-542-01) | October 15, 2025 |
| 69292-542-10 | 69292-542 | Amici Pharma, Inc | 1000 TABLET in 1 BOTTLE (69292-542-10) | October 15, 2025 |
| 69292-542-50 | 69292-542 | Amici Pharma, Inc | 500 TABLET in 1 BOTTLE (69292-542-50) | September 5, 2026 |
| 69292-544-01 | 69292-544 | Amici Pharma, Inc | 100 TABLET in 1 BOTTLE (69292-544-01) | October 15, 2025 |
| 69292-544-10 | 69292-544 | Amici Pharma, Inc | 1000 TABLET in 1 BOTTLE (69292-544-10) | October 15, 2025 |
| 69292-544-50 | 69292-544 | Amici Pharma, Inc | 500 TABLET in 1 BOTTLE (69292-544-50) | September 5, 2026 |
| 69292-546-01 | 69292-546 | Amici Pharma, Inc | 100 TABLET in 1 BOTTLE (69292-546-01) | October 15, 2025 |
| 69292-546-10 | 69292-546 | Amici Pharma, Inc | 1000 TABLET in 1 BOTTLE (69292-546-10) | October 15, 2025 |
| 63629-7895-1 | 63629-7895 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-7895-1) | January 15, 2019 |
| 63629-7895-2 | 63629-7895 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-7895-2) | January 15, 2019 |
| 71335-1910-1 | 71335-1910 | Bryant Ranch Prepack | 150 TABLET in 1 BOTTLE (71335-1910-1) | August 20, 2026 |
| 71335-1910-2 | 71335-1910 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-1910-2) | October 27, 2023 |
| 71335-1910-3 | 71335-1910 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-1910-3) | September 17, 2021 |
| 71335-1910-4 | 71335-1910 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-1910-4) | August 20, 2026 |
| 71335-1910-5 | 71335-1910 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-1910-5) | August 11, 2021 |
| 71335-1910-6 | 71335-1910 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-1910-6) | August 20, 2026 |
| 71335-2252-1 | 71335-2252 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2252-1) | August 20, 2026 |
| 71335-2252-2 | 71335-2252 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2252-2) | August 20, 2026 |
| 71335-2382-1 | 71335-2382 | Bryant Ranch Prepack | 150 TABLET in 1 BOTTLE (71335-2382-1) | July 8, 2024 |
| 71335-2382-2 | 71335-2382 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2382-2) | July 8, 2024 |
| 71335-2382-3 | 71335-2382 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2382-3) | July 8, 2024 |
| 71335-2382-4 | 71335-2382 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2382-4) | July 8, 2024 |
| 71335-2382-5 | 71335-2382 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2382-5) | July 8, 2024 |
| 71335-2608-1 | 71335-2608 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-2608-1) | August 24, 2026 |
| 71335-2608-2 | 71335-2608 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-2608-2) | February 24, 2025 |
| 71335-2608-3 | 71335-2608 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-2608-3) | August 24, 2026 |
| 71335-2608-4 | 71335-2608 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-2608-4) | March 4, 2025 |
| 71335-2608-5 | 71335-2608 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-2608-5) | August 24, 2026 |
| 71335-3085-1 | 71335-3085 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3085-1) | February 16, 2026 |
| 71335-3085-2 | 71335-3085 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3085-2) | February 16, 2026 |
| 71335-3136-1 | 71335-3136 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-3136-1) | May 27, 2026 |
| 71335-3136-2 | 71335-3136 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3136-2) | May 27, 2026 |
| 71335-3136-3 | 71335-3136 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-3136-3) | May 27, 2026 |
| 71335-3136-4 | 71335-3136 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3136-4) | May 27, 2026 |
| 71335-3136-5 | 71335-3136 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-3136-5) | May 27, 2026 |
| 71335-3164-1 | 71335-3164 | Bryant Ranch Prepack | 150 TABLET in 1 BOTTLE (71335-3164-1) | August 4, 2026 |
| 71335-3164-2 | 71335-3164 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-3164-2) | August 4, 2026 |
| 71335-3164-3 | 71335-3164 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-3164-3) | August 4, 2026 |
| 71335-3164-4 | 71335-3164 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-3164-4) | August 4, 2026 |
| 71335-3164-5 | 71335-3164 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-3164-5) | August 4, 2026 |
| 71335-3164-6 | 71335-3164 | Bryant Ranch Prepack | 10 TABLET in 1 BOTTLE (71335-3164-6) | August 4, 2026 |
| 71335-9604-1 | 71335-9604 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-9604-1) | December 20, 2022 |
| 71335-9604-2 | 71335-9604 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-9604-2) | December 20, 2022 |
| 71335-9604-3 | 71335-9604 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-9604-3) | December 20, 2022 |
| 71335-9604-4 | 71335-9604 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-9604-4) | December 20, 2022 |
| 71335-9604-5 | 71335-9604 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (71335-9604-5) | December 20, 2022 |
| 71335-9649-1 | 71335-9649 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-9649-1) | April 3, 2024 |
| 71335-9649-2 | 71335-9649 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-9649-2) | April 3, 2024 |
| 71335-9649-3 | 71335-9649 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-9649-3) | March 24, 2023 |
| 71335-9649-4 | 71335-9649 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-9649-4) | February 13, 2023 |
| 71335-9698-1 | 71335-9698 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-9698-1) | May 11, 2023 |
| 71335-9698-2 | 71335-9698 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-9698-2) | May 11, 2023 |
| 71335-9698-3 | 71335-9698 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-9698-3) | May 11, 2023 |
| 71335-9698-4 | 71335-9698 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-9698-4) | May 11, 2023 |
| 62135-589-90 | 62135-589 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-589-90) | April 27, 2023 |
| 62135-590-90 | 62135-590 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-590-90) | April 27, 2023 |
| 62135-591-90 | 62135-591 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-591-90) | April 27, 2023 |
| 62135-592-90 | 62135-592 | Chartwell RX, LLC | 90 TABLET in 1 BOTTLE (62135-592-90) | April 27, 2023 |
| 67046-0798-3 | 67046-0798 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-0798-3) | April 28, 2026 |
| 67046-1254-3 | 67046-1254 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1254-3) | August 26, 2026 |
| 67046-1504-3 | 67046-1504 | Coupler LLC | 30 TABLET in 1 BLISTER PACK (67046-1504-3) | January 28, 2025 |
| 51407-828-10 | 51407-828 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-828-10) | October 9, 2023 |
| 51407-828-90 | 51407-828 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (51407-828-90) | October 9, 2023 |
| 60429-183-10 | 60429-183 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (60429-183-10) | November 4, 2013 |
| 60429-183-90 | 60429-183 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-183-90) | November 4, 2013 |
| 60429-184-10 | 60429-184 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (60429-184-10) | November 4, 2013 |
| 60429-184-90 | 60429-184 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-184-90) | November 4, 2013 |
| 60429-186-10 | 60429-186 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (60429-186-10) | November 4, 2013 |
| 60429-186-90 | 60429-186 | Golden State Medical Supply, Inc. | 90 TABLET in 1 BOTTLE (60429-186-90) | November 4, 2013 |
| 23155-704-01 | 23155-704 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-704-01) | April 28, 2020 |
| 23155-704-10 | 23155-704 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-704-10) | April 28, 2020 |
| 23155-705-01 | 23155-705 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-705-01) | April 28, 2020 |
| 23155-705-10 | 23155-705 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-705-10) | April 28, 2020 |
| 23155-772-01 | 23155-772 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-772-01) | October 1, 2020 |
| 23155-772-10 | 23155-772 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-772-10) | October 1, 2020 |
| 23155-773-01 | 23155-773 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (23155-773-01) | October 1, 2020 |
| 23155-773-05 | 23155-773 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 500 TABLET in 1 BOTTLE (23155-773-05) | October 1, 2020 |
| 23155-773-10 | 23155-773 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 1000 TABLET in 1 BOTTLE (23155-773-10) | October 1, 2020 |
| 68645-605-90 | 68645-605 | Legacy Pharmaceutical Packaging, LLC | 90 TABLET in 1 BOTTLE (68645-605-90) | November 14, 2022 |
| 68645-606-90 | 68645-606 | Legacy Pharmaceutical Packaging, LLC | 90 TABLET in 1 BOTTLE (68645-606-90) | November 14, 2022 |
| 68645-607-90 | 68645-607 | Legacy Pharmaceutical Packaging, LLC | 90 TABLET in 1 BOTTLE (68645-607-90) | November 14, 2022 |
| 0904-7309-61 | 0904-7309 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7309-61) / 1 TABLET in 1 BLISTER PACK | August 28, 2025 |
| 0904-7310-61 | 0904-7310 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7310-61) / 1 TABLET in 1 BLISTER PACK | August 28, 2025 |
| 0904-7311-61 | 0904-7311 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7311-61) / 1 TABLET in 1 BLISTER PACK | August 28, 2025 |
| 0904-7312-61 | 0904-7312 | Major Pharmaceuticals | 100 BLISTER PACK in 1 CARTON (0904-7312-61) / 1 TABLET in 1 BLISTER PACK | August 28, 2025 |
| 16714-442-01 | 16714-442 | Northstar RxLLC | 100 TABLET in 1 BOTTLE (16714-442-01) | August 6, 2015 |
| 16714-442-02 | 16714-442 | Northstar RxLLC | 1000 TABLET in 1 BOTTLE (16714-442-02) | August 6, 2015 |
| 16714-443-01 | 16714-443 | Northstar RxLLC | 100 TABLET in 1 BOTTLE (16714-443-01) | August 6, 2015 |
| 16714-443-02 | 16714-443 | Northstar RxLLC | 1000 TABLET in 1 BOTTLE (16714-443-02) | August 6, 2015 |
| 16714-444-01 | 16714-444 | Northstar RxLLC | 100 TABLET in 1 BOTTLE (16714-444-01) | August 6, 2015 |
| 16714-444-02 | 16714-444 | Northstar RxLLC | 1000 TABLET in 1 BOTTLE (16714-444-02) | August 6, 2015 |
| 16714-445-01 | 16714-445 | Northstar RxLLC | 100 TABLET in 1 BOTTLE (16714-445-01) | August 6, 2015 |
| 16714-445-02 | 16714-445 | Northstar RxLLC | 1000 TABLET in 1 BOTTLE (16714-445-02) | August 6, 2015 |
| 51655-006-26 | 51655-006 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-006-26) | September 6, 2022 |
| 51655-006-52 | 51655-006 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-006-52) | July 11, 2022 |
| 51655-058-26 | 51655-058 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-058-26) | July 11, 2022 |
| 51655-058-52 | 51655-058 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-058-52) | March 10, 2023 |
| 51655-110-26 | 51655-110 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-110-26) | September 7, 2022 |
| 51655-110-52 | 51655-110 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-110-52) | October 17, 2022 |
| 51655-341-26 | 51655-341 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-341-26) | May 28, 2020 |
| 68071-3820-3 | 68071-3820 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68071-3820-3) | March 27, 2025 |
| 68071-3820-9 | 68071-3820 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68071-3820-9) | March 12, 2026 |
| 68071-1793-1 | 68071-1793 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-1793-1) | May 31, 2023 |
| 68071-3408-1 | 68071-3408 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3408-1) | June 15, 2023 |
| 68071-3537-3 | 68071-3537 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-3537-3) | November 28, 2023 |
| 68682-710-01 | 68682-710 | OCEANSIDE PHARMACEUTICALS | 100 TABLET in 1 BOTTLE (68682-710-01) | July 26, 1988 |
| 68682-710-10 | 68682-710 | OCEANSIDE PHARMACEUTICALS | 1000 TABLET in 1 BOTTLE (68682-710-10) | July 26, 1988 |
| 68682-711-01 | 68682-711 | OCEANSIDE PHARMACEUTICALS | 100 TABLET in 1 BOTTLE (68682-711-01) | December 24, 1985 |
| 68682-711-10 | 68682-711 | OCEANSIDE PHARMACEUTICALS | 1000 TABLET in 1 BOTTLE (68682-711-10) | December 24, 1985 |
| 68682-712-01 | 68682-712 | OCEANSIDE PHARMACEUTICALS | 100 TABLET in 1 BOTTLE (68682-712-01) | December 24, 1985 |
| 68682-712-10 | 68682-712 | OCEANSIDE PHARMACEUTICALS | 1000 TABLET in 1 BOTTLE (68682-712-10) | December 24, 1985 |
| 68682-713-01 | 68682-713 | OCEANSIDE PHARMACEUTICALS | 100 TABLET in 1 BOTTLE (68682-713-01) | December 24, 1985 |
| 68682-713-10 | 68682-713 | OCEANSIDE PHARMACEUTICALS | 1000 TABLET in 1 BOTTLE (68682-713-10) | December 24, 1985 |
| 72789-318-90 | 72789-318 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-318-90) | April 4, 2023 |
| 72789-329-90 | 72789-329 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (72789-329-90) | June 15, 2023 |
| 68788-8385-1 | 68788-8385 | Preferred Pharmaceuicals Inc. | 100 TABLET in 1 BOTTLE (68788-8385-1) | March 1, 2023 |
| 68788-8385-3 | 68788-8385 | Preferred Pharmaceuicals Inc. | 30 TABLET in 1 BOTTLE (68788-8385-3) | March 1, 2023 |
| 68788-8385-6 | 68788-8385 | Preferred Pharmaceuicals Inc. | 60 TABLET in 1 BOTTLE (68788-8385-6) | March 1, 2023 |
| 68788-8385-9 | 68788-8385 | Preferred Pharmaceuicals Inc. | 90 TABLET in 1 BOTTLE (68788-8385-9) | March 1, 2023 |
| 68788-4147-0 | 68788-4147 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-4147-0) | July 10, 2026 |
| 68788-4147-3 | 68788-4147 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-4147-3) | July 10, 2026 |
| 68788-4147-6 | 68788-4147 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-4147-6) | July 10, 2026 |
| 68788-4147-9 | 68788-4147 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-4147-9) | July 10, 2026 |
| 68788-4164-1 | 68788-4164 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-4164-1) | July 23, 2026 |
| 68788-4164-3 | 68788-4164 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-4164-3) | July 23, 2026 |
| 68788-4164-6 | 68788-4164 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-4164-6) | July 23, 2026 |
| 68788-4164-9 | 68788-4164 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-4164-9) | July 23, 2026 |
| 68788-8320-1 | 68788-8320 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8320-1) | January 24, 2023 |
| 68788-8320-3 | 68788-8320 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8320-3) | January 24, 2023 |
| 68788-8320-6 | 68788-8320 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8320-6) | January 24, 2023 |
| 68788-8320-9 | 68788-8320 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8320-9) | January 24, 2023 |
| 68788-8437-1 | 68788-8437 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-8437-1) | April 28, 2023 |
| 68788-8437-3 | 68788-8437 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-8437-3) | April 28, 2023 |
| 68788-8437-6 | 68788-8437 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-8437-6) | April 28, 2023 |
| 68788-8437-9 | 68788-8437 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-8437-9) | April 28, 2023 |
| 63187-977-30 | 63187-977 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-977-30) | February 1, 2018 |
| 63187-977-60 | 63187-977 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-977-60) | February 1, 2018 |
| 63187-977-90 | 63187-977 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-977-90) | February 1, 2018 |
| 71205-075-30 | 71205-075 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-075-30) | July 2, 2018 |
| 71205-075-60 | 71205-075 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-075-60) | July 2, 2018 |
| 71205-075-90 | 71205-075 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-075-90) | July 2, 2018 |
| 70518-3572-2 | 70518-3572 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3572-2) | May 28, 2025 |
| 70518-4011-1 | 70518-4011 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4011-1) | September 13, 2025 |
| 70518-4011-2 | 70518-4011 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-4011-2) | July 21, 2026 |
| 70518-4153-0 | 70518-4153 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4153-0) | August 1, 2024 |
| 70518-4153-1 | 70518-4153 | REMEDYREPACK INC. | 100 TABLET in 1 BOTTLE, PLASTIC (70518-4153-1) | March 20, 2025 |
| 70518-4197-0 | 70518-4197 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4197-0) | October 1, 2024 |
| 70518-4197-1 | 70518-4197 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4197-1) | May 3, 2025 |
| 70518-4197-2 | 70518-4197 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4197-2) | July 13, 2025 |
| 70518-4210-0 | 70518-4210 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4210-0) | October 10, 2024 |
| 70518-4210-1 | 70518-4210 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-4210-1) | May 16, 2025 |
| 70518-4256-0 | 70518-4256 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-4256-0) | January 15, 2025 |
| 64980-685-01 | 64980-685 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-685-01) | February 24, 2025 |
| 64980-685-10 | 64980-685 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-685-10) | February 24, 2025 |
| 64980-686-01 | 64980-686 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-686-01) | February 24, 2025 |
| 64980-686-10 | 64980-686 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-686-10) | February 24, 2025 |
| 64980-687-01 | 64980-687 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-687-01) | February 24, 2025 |
| 64980-687-10 | 64980-687 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-687-10) | February 24, 2025 |
| 64980-688-01 | 64980-688 | Rising Pharma Holdings, Inc. | 100 TABLET in 1 BOTTLE (64980-688-01) | February 24, 2025 |
| 64980-688-10 | 64980-688 | Rising Pharma Holdings, Inc. | 1000 TABLET in 1 BOTTLE (64980-688-10) | February 24, 2025 |
| 50228-228-01 | 50228-228 | ScieGen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (50228-228-01) | February 12, 2025 |
| 50228-228-10 | 50228-228 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (50228-228-10) | February 12, 2025 |
| 50228-229-01 | 50228-229 | ScieGen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (50228-229-01) | February 12, 2025 |
| 50228-229-10 | 50228-229 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (50228-229-10) | February 12, 2025 |
| 50228-230-01 | 50228-230 | ScieGen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (50228-230-01) | February 12, 2025 |
| 50228-230-10 | 50228-230 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (50228-230-10) | February 12, 2025 |
| 50228-231-01 | 50228-231 | ScieGen Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (50228-231-01) | February 12, 2025 |
| 50228-231-10 | 50228-231 | ScieGen Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (50228-231-10) | February 12, 2025 |
| 43547-545-03 | 43547-545 | Solco Healthcare US, LLC | 30 TABLET in 1 BOTTLE (43547-545-03) | July 31, 2022 |
| 43547-545-09 | 43547-545 | Solco Healthcare US, LLC | 90 TABLET in 1 BOTTLE (43547-545-09) | July 31, 2022 |
| 43547-545-10 | 43547-545 | Solco Healthcare US, LLC | 100 TABLET in 1 BOTTLE (43547-545-10) | July 31, 2022 |
| 43547-545-11 | 43547-545 | Solco Healthcare US, LLC | 1000 TABLET in 1 BOTTLE (43547-545-11) | July 31, 2022 |
| 43547-545-50 | 43547-545 | Solco Healthcare US, LLC | 500 TABLET in 1 BOTTLE (43547-545-50) | July 31, 2022 |
| 43547-546-03 | 43547-546 | Solco Healthcare US, LLC | 30 TABLET in 1 BOTTLE (43547-546-03) | July 31, 2022 |
| 43547-546-09 | 43547-546 | Solco Healthcare US, LLC | 90 TABLET in 1 BOTTLE (43547-546-09) | July 31, 2022 |
| 43547-546-10 | 43547-546 | Solco Healthcare US, LLC | 100 TABLET in 1 BOTTLE (43547-546-10) | July 31, 2022 |
| 43547-546-11 | 43547-546 | Solco Healthcare US, LLC | 1000 TABLET in 1 BOTTLE (43547-546-11) | July 31, 2022 |
| 43547-546-50 | 43547-546 | Solco Healthcare US, LLC | 500 TABLET in 1 BOTTLE (43547-546-50) | July 31, 2022 |
| 43547-547-03 | 43547-547 | Solco Healthcare US, LLC | 30 TABLET in 1 BOTTLE (43547-547-03) | July 31, 2022 |
| 43547-547-09 | 43547-547 | Solco Healthcare US, LLC | 90 TABLET in 1 BOTTLE (43547-547-09) | July 31, 2022 |
| 43547-547-10 | 43547-547 | Solco Healthcare US, LLC | 100 TABLET in 1 BOTTLE (43547-547-10) | July 31, 2022 |
| 43547-547-11 | 43547-547 | Solco Healthcare US, LLC | 1000 TABLET in 1 BOTTLE (43547-547-11) | July 31, 2022 |
| 43547-547-50 | 43547-547 | Solco Healthcare US, LLC | 500 TABLET in 1 BOTTLE (43547-547-50) | July 31, 2022 |
| 43547-548-03 | 43547-548 | Solco Healthcare US, LLC | 30 TABLET in 1 BOTTLE (43547-548-03) | July 31, 2022 |
| 43547-548-09 | 43547-548 | Solco Healthcare US, LLC | 90 TABLET in 1 BOTTLE (43547-548-09) | July 31, 2022 |
| 43547-548-10 | 43547-548 | Solco Healthcare US, LLC | 100 TABLET in 1 BOTTLE (43547-548-10) | July 31, 2022 |
| 43547-548-11 | 43547-548 | Solco Healthcare US, LLC | 1000 TABLET in 1 BOTTLE (43547-548-11) | July 31, 2022 |
| 43547-548-50 | 43547-548 | Solco Healthcare US, LLC | 500 TABLET in 1 BOTTLE (43547-548-50) | July 31, 2022 |
| 60760-575-30 | 60760-575 | St. Mary's Medical Park Pharmacy | 30 TABLET in 1 BOTTLE, PLASTIC (60760-575-30) | October 31, 2022 |
| 51672-4037-1 | 51672-4037 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (51672-4037-1) | January 23, 2001 |
| 51672-4037-3 | 51672-4037 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (51672-4037-3) | January 23, 2001 |
| 51672-4038-1 | 51672-4038 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (51672-4038-1) | January 23, 2001 |
| 51672-4038-3 | 51672-4038 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (51672-4038-3) | January 23, 2001 |
| 51672-4040-1 | 51672-4040 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (51672-4040-1) | January 23, 2001 |
| 51672-4040-3 | 51672-4040 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (51672-4040-3) | January 23, 2001 |
| 51672-4245-1 | 51672-4245 | Sun Pharmaceutical Industries, Inc. | 100 TABLET in 1 BOTTLE (51672-4245-1) | July 17, 2023 |
| 51672-4245-3 | 51672-4245 | Sun Pharmaceutical Industries, Inc. | 1000 TABLET in 1 BOTTLE (51672-4245-3) | July 17, 2023 |
| 50090-3378 | 50090-3378 | A-S Medication Solutions | — | January 23, 2001 |
| 50090-4560 | 50090-4560 | A-S Medication Solutions | — | January 23, 2001 |
| 50090-6437 | 50090-6437 | A-S Medication Solutions | — | October 1, 2020 |
| 50090-6490 | 50090-6490 | A-S Medication Solutions | — | August 6, 2015 |
| 50090-6712 | 50090-6712 | A-S Medication Solutions | — | January 23, 2001 |
| 50090-7222 | 50090-7222 | A-S Medication Solutions | — | April 28, 2020 |
| 50090-7302 | 50090-7302 | A-S Medication Solutions | — | April 24, 2022 |
| 50090-7677 | 50090-7677 | A-S Medication Solutions | — | February 12, 2025 |
| 50090-7678 | 50090-7678 | A-S Medication Solutions | — | February 12, 2025 |
| 69292-540 | 69292-540 | Amici Pharma, Inc | — | October 15, 2025 |
| 69292-542 | 69292-542 | Amici Pharma, Inc | — | October 15, 2025 |
| 69292-544 | 69292-544 | Amici Pharma, Inc | — | October 15, 2025 |
| 69292-546 | 69292-546 | Amici Pharma, Inc | — | October 15, 2025 |
| 63629-7895 | 63629-7895 | Bryant Ranch Prepack | — | January 23, 2001 |
| 71335-1910 | 71335-1910 | Bryant Ranch Prepack | — | January 23, 2001 |
| 71335-2252 | 71335-2252 | Bryant Ranch Prepack | — | January 23, 2001 |
| 71335-2382 | 71335-2382 | Bryant Ranch Prepack | — | April 24, 2022 |
| 71335-2608 | 71335-2608 | Bryant Ranch Prepack | — | January 23, 2001 |
| 71335-3085 | 71335-3085 | Bryant Ranch Prepack | — | July 31, 2022 |
| 71335-3136 | 71335-3136 | Bryant Ranch Prepack | — | February 24, 2025 |
| 71335-3164 | 71335-3164 | Bryant Ranch Prepack | — | February 24, 2025 |
| 71335-9604 | 71335-9604 | Bryant Ranch Prepack | — | April 24, 2022 |
| 71335-9649 | 71335-9649 | Bryant Ranch Prepack | — | January 23, 2001 |
| 71335-9698 | 71335-9698 | Bryant Ranch Prepack | — | April 24, 2022 |
| 62135-589 | 62135-589 | Chartwell RX, LLC | — | April 28, 2020 |
| 62135-590 | 62135-590 | Chartwell RX, LLC | — | April 28, 2020 |
| 62135-591 | 62135-591 | Chartwell RX, LLC | — | October 1, 2020 |
| 62135-592 | 62135-592 | Chartwell RX, LLC | — | October 1, 2020 |
| 67046-0798 | 67046-0798 | Coupler LLC | — | April 28, 2026 |
| 67046-1254 | 67046-1254 | Coupler LLC | — | August 26, 2026 |
| 67046-1504 | 67046-1504 | Coupler LLC | — | January 28, 2025 |
| 51407-828 | 51407-828 | Golden State Medical Supply, Inc. | — | January 23, 2001 |
| 60429-183 | 60429-183 | Golden State Medical Supply, Inc. | — | January 23, 2001 |
| 60429-184 | 60429-184 | Golden State Medical Supply, Inc. | — | January 23, 2001 |
| 60429-186 | 60429-186 | Golden State Medical Supply, Inc. | — | January 23, 2001 |
| 23155-704 | 23155-704 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | April 28, 2020 |
| 23155-705 | 23155-705 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | April 28, 2020 |
| 23155-772 | 23155-772 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | October 1, 2020 |
| 23155-773 | 23155-773 | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | — | October 1, 2020 |
| 68645-605 | 68645-605 | Legacy Pharmaceutical Packaging, LLC | — | April 28, 2020 |
| 68645-606 | 68645-606 | Legacy Pharmaceutical Packaging, LLC | — | October 1, 2020 |
| 68645-607 | 68645-607 | Legacy Pharmaceutical Packaging, LLC | — | October 1, 2020 |
| 0904-7309 | 0904-7309 | Major Pharmaceuticals | — | August 28, 2025 |
| 0904-7310 | 0904-7310 | Major Pharmaceuticals | — | August 28, 2025 |
| 0904-7311 | 0904-7311 | Major Pharmaceuticals | — | August 28, 2025 |
| 0904-7312 | 0904-7312 | Major Pharmaceuticals | — | August 28, 2025 |
| 16714-442 | 16714-442 | Northstar RxLLC | — | August 6, 2015 |
| 16714-443 | 16714-443 | Northstar RxLLC | — | August 6, 2015 |
| 16714-444 | 16714-444 | Northstar RxLLC | — | August 6, 2015 |
| 16714-445 | 16714-445 | Northstar RxLLC | — | August 6, 2015 |
| 51655-006 | 51655-006 | Northwind Health Company, LLC | — | July 11, 2022 |
| 51655-058 | 51655-058 | Northwind Health Company, LLC | — | July 11, 2022 |
| 51655-110 | 51655-110 | Northwind Health Company, LLC | — | September 7, 2022 |
| 51655-341 | 51655-341 | Northwind Health Company, LLC | — | May 28, 2020 |
| 68071-3820 | 68071-3820 | NuCare Pharmaceuticals, Inc. | — | April 24, 2022 |
| 68071-1793 | 68071-1793 | NuCare Pharmaceuticals,Inc. | — | April 24, 2022 |
| 68071-3408 | 68071-3408 | NuCare Pharmaceuticals,Inc. | — | April 24, 2022 |
| 68071-3537 | 68071-3537 | NuCare Pharmaceuticals,Inc. | — | April 24, 2022 |
| 68682-710 | 68682-710 | OCEANSIDE PHARMACEUTICALS | — | July 26, 1988 |
| 68682-711 | 68682-711 | OCEANSIDE PHARMACEUTICALS | — | December 24, 1985 |
| 68682-712 | 68682-712 | OCEANSIDE PHARMACEUTICALS | — | December 24, 1985 |
| 68682-713 | 68682-713 | OCEANSIDE PHARMACEUTICALS | — | December 24, 1985 |
| 72789-318 | 72789-318 | PD-Rx Pharmaceuticals, Inc. | — | July 31, 2022 |
| 72789-329 | 72789-329 | PD-Rx Pharmaceuticals, Inc. | — | July 31, 2022 |
| 68788-8385 | 68788-8385 | Preferred Pharmaceuicals Inc. | — | March 1, 2023 |
| 68788-4147 | 68788-4147 | Preferred Pharmaceuticals Inc. | — | July 10, 2026 |
| 68788-4164 | 68788-4164 | Preferred Pharmaceuticals Inc. | — | July 23, 2026 |
| 68788-8320 | 68788-8320 | Preferred Pharmaceuticals Inc. | — | January 24, 2023 |
| 68788-8437 | 68788-8437 | Preferred Pharmaceuticals Inc. | — | April 28, 2023 |
| 63187-977 | 63187-977 | Proficient Rx LP | — | January 23, 2001 |
| 71205-075 | 71205-075 | Proficient Rx LP | — | December 24, 1985 |
| 70518-3572 | 70518-3572 | REMEDYREPACK INC. | — | November 7, 2022 |
| 70518-4011 | 70518-4011 | REMEDYREPACK INC. | — | February 6, 2024 |
| 70518-4153 | 70518-4153 | REMEDYREPACK INC. | — | August 1, 2024 |
| 70518-4197 | 70518-4197 | REMEDYREPACK INC. | — | October 1, 2024 |
| 70518-4210 | 70518-4210 | REMEDYREPACK INC. | — | October 10, 2024 |
| 70518-4256 | 70518-4256 | REMEDYREPACK INC. | — | January 15, 2025 |
| 64980-685 | 64980-685 | Rising Pharma Holdings, Inc. | — | February 24, 2025 |
| 64980-686 | 64980-686 | Rising Pharma Holdings, Inc. | — | February 24, 2025 |
| 64980-687 | 64980-687 | Rising Pharma Holdings, Inc. | — | February 24, 2025 |
| 64980-688 | 64980-688 | Rising Pharma Holdings, Inc. | — | February 24, 2025 |
| 50228-228 | 50228-228 | ScieGen Pharmaceuticals, Inc. | — | February 12, 2025 |
| 50228-229 | 50228-229 | ScieGen Pharmaceuticals, Inc. | — | February 12, 2025 |
| 50228-230 | 50228-230 | ScieGen Pharmaceuticals, Inc. | — | February 12, 2025 |
| 50228-231 | 50228-231 | ScieGen Pharmaceuticals, Inc. | — | February 12, 2025 |
| 43547-545 | 43547-545 | Solco Healthcare US, LLC | — | July 31, 2022 |
| 43547-546 | 43547-546 | Solco Healthcare US, LLC | — | July 31, 2022 |
| 43547-547 | 43547-547 | Solco Healthcare US, LLC | — | July 31, 2022 |
| 43547-548 | 43547-548 | Solco Healthcare US, LLC | — | July 31, 2022 |
| 60760-575 | 60760-575 | St. Mary's Medical Park Pharmacy | — | October 31, 2022 |
| 51672-4037 | 51672-4037 | Sun Pharmaceutical Industries, Inc. | — | January 23, 2001 |
| 51672-4038 | 51672-4038 | Sun Pharmaceutical Industries, Inc. | — | January 23, 2001 |
| 51672-4040 | 51672-4040 | Sun Pharmaceutical Industries, Inc. | — | January 23, 2001 |
| 51672-4245 | 51672-4245 | Sun Pharmaceutical Industries, Inc. | — | January 23, 2001 |
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 · 13 sections on this page.