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Lovastatin
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Lovastatin | 10 mg/1 | 197905 | — |
| Lovastatin | 20 mg/1 | 197905 | — |
| Lovastatin | 40 mg/1 | 197905 | — |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| HMG-CoA Reductase Inhibitor [EPC] | EPC | All 33 members |
| Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] | MoA | All 33 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 075991-001 | LOVASTATIN | TABLET | LOVASTATIN | Prescription | AB | ||
| 075991-002 | LOVASTATIN | TABLET | LOVASTATIN | Prescription | AB | ||
| 075991-003 | LOVASTATIN | TABLET | LOVASTATIN | Prescription | AB | RS |
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 | 21 | Labeling | Approved | September 25, 2020 | Standard |
| Supplement | 19 | Labeling | Approved | August 4, 2017 | Standard |
| Supplement | 17 | Labeling | Approved | December 1, 2014 | Standard |
| Supplement | 16 | Labeling | Approved | April 29, 2013 | Standard |
| Supplement | 15 | Labeling | Approved | October 12, 2012 | Standard |
| Supplement | 12 | Labeling | Approved | May 3, 2010 | — |
| Supplement | 13 | Labeling | Approved | October 22, 2009 | — |
| Supplement | 7 | Labeling | Approved | March 2, 2006 | — |
| Supplement | 2 | Labeling | Approved | June 30, 2004 | — |
| Original application | 1 | Approved | June 5, 2002 | — |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260403). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingINDICATIONS AND USAGE Therapy with Lovastatin Tablets USP should be a component of multiple risk factor intervention in those individuals with dyslipidemia at risk for atherosclerotic vascular disease. Lovastatin Tablets USP should be used in addition to a diet restricted in saturated fat and cholesterol as part of a treatment strategy to lower total-C and LDL-C to target levels when the response to diet and other nonpharmacological measures alone has been inadequate to reduce risk. Primary Prevention of Coronary Heart Disease In individuals without symptomatic cardiovascular disease, average to moderately elevated total-C and LDL-C, and below average HDL-C, Lovastatin Tablets USP are indicated to reduce the risk of: - Myocardial infarction - Unstable angina - Coronary revascularization procedures (See CLINICAL PHARMACOLOGY , Clinical Studies in Adults .) Coronary Heart Disease Lovastatin Tablets USP are indicated to slow the progression of coronary atherosclerosis in patients with coronary heart disease as part of a treatment strategy to lower total-C and LDL-C to target levels. Hypercholesterolemia Therapy with lipid-altering agents should be a component of multiple risk factor intervention in those individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Lovastatin Tablets USP are indicated as an adjunct to diet for the reduction of elevated total-C and LDL-C levels in patients with primary hypercholesterolemia (Types IIa and IIb 2 ), when the response to diet restricted in saturated fat and cholesterol and to other nonpharmacological measures alone has been inadequate. 2 Classification of Hyperlipoproteinemias Lipid Elevations Type Lipoproteins elevated major minor I chylomicrons TG ↑→C IIa LDL C — IIb LDL, VLDL C TG III (rare) IDL C/TG — IV VLDL TG ↑→C V (rare) chylomicrons, VLDL TG ↑→C IDL = intermediate-density lipoprotein. Adolescent Patients With Heterozygous Familial Hypercholesterolemia Lovastatin Tablets USP are indicated as an adjunct to diet to reduce total-C, LDL-C and apolipoprotein B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with heFH if after an adequate trial of diet therapy the following findings are present: 1. LDL-C remains > 189 mg/dL or 2. LDL-C remains > 160 mg/dL and : • there is a positive family history of premature cardiovascular disease or • two or more other CVD risk factors are present in the adolescent patient General Recommendations Prior to initiating therapy with lovastatin, secondary causes for hypercholesterolemia (e.g., poorly controlled diabetes mellitus, hypothyroidism, nephrotic syndrome, dysproteinemias, obstructive liver disease, other drug therapy, alcoholism) should be excluded, and a lipid profile performed to measure total-C, HDL-C, and TG. For patients with TG less than 400 mg/dL ( 400 mg/dL (> 4.5 mmol/L), this equation is less accurate and LDL-C concentrations should be determined by ultracentrifugation. In hypertriglyceridemic patients, LDL-C may be low or normal despite elevated total-C. In such cases, Lovastatin Tablets USP are not indicated. The National Cholesterol Education Program (NCEP) Treatment Guidelines are summarized below: NCEP Treatment Guidelines: LDL-C Goals and Cutpoints for Therapeutic Lifestyle Changes and Drug Therapy in Different Risk Categories Risk Category LDL Goal (mg/dL) LDL Level at Which to Initiate Therapeutic Lifestyle Changes (mg/dL) LDL Level at Which to Consider Drug Therapy (mg/dL) CHD CHD, coronary heart disease or CHD risk equivalents (10 year risk > 20%) < 100 ≥ 100 ≥ 130 (100 to 129: drug optional) Some authorities recommend use of LDL-lowering drugs in this category if an LDL-C level of < 100 mg/dL cannot be achieved by therapeutic lifestyle changes. Others prefer use of drugs that primarily modify triglycerides and HDL-C, e.g., nicotinic acid or fibrate. Clinical judgment also may call for deferring drug therapy in this subcate …
Dosage and Administration
openFDA Drug LabelingDOSAGE AND ADMINISTRATION The patient should be placed on a standard cholesterol-lowering diet before receiving lovastatin tablets and should continue on this diet during treatment with lovastatin tablets (see NCEP Treatment Guidelines for details on dietary therapy). Lovastatin tablets should be given with meals. Adult Patients The usual recommended starting dose is 20 mg once a day given with the evening meal. The recommended dosing range of lovastatin is 10 to 80 mg/day in single or two divided doses; the maximum recommended dose is 80 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Treatment Guidelines and CLINICAL PHARMACOLOGY ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal (see INDICATIONS AND USAGE ) should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. Cholesterol levels should be monitored periodically and consideration should be given to reducing the dosage of lovastatin tablets if cholesterol levels fall significantly below the targeted range. Dosage in Patients Taking Danazol, Diltiazem, Dronedarone or Verapamil In patients taking danazol, diltiazem, dronedarone or verapamil concomitantly with lovastatin, therapy should begin with 10 mg of lovastatin and should not exceed 20 mg/day (see CLINICAL PHARMACOLOGY , Pharmacokinetics , WARNINGS , Myopathy/Rhabdomyolysis , PRECAUTIONS , Drug Interactions , Other Drug Interactions ). Dosage in Patients Taking Amiodarone In patients taking amiodarone concomitantly with lovastatin tablets, the dose should not exceed 40 mg/day (see WARNINGS , Myopathy/Rhabdomyolysis and PRECAUTIONS , Drug Interactions , Other Drug Interactions ). Adolescent Patients (10 to 17 Years of Age) With Heterozygous Familial Hypercholesterolemia The recommended dosing range of lovastatin is 10 to 40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy (see NCEP Pediatric Panel Guidelines 4 , CLINICAL PHARMACOLOGY , and INDICATIONS AND USAGE ). Patients requiring reductions in LDL-C of 20% or more to achieve their goal should be started on 20 mg/day of lovastatin tablets. A starting dose of 10 mg of lovastatin may be considered for patients requiring smaller reductions. Adjustments should be made at intervals of 4 weeks or more. 4 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics . 89(3):495-501. 1992. Concomitant Lipid-Lowering Therapy Lovastatin tablets are effective alone or when used concomitantly with bile-acid sequestrants (see WARNINGS , Myopathy/Rhabdomyolysis and PRECAUTIONS , Drug Interactions ). Dosage in Patients With Renal Insufficiency In patients with severe renal insufficiency (creatinine clearance < 30 mL/min), dosage increases above 20 mg/day should be carefully considered and, if deemed necessary, implemented cautiously (see CLINICAL PHARMACOLOGY and WARNINGS , Myopathy/Rhabdomyolysis ).
Contraindications
openFDA Drug LabelingCONTRAINDICATIONS Hypersensitivity to any component of this medication. Active liver disease or unexplained persistent elevations of serum transaminases (see WARNINGS ). Concomitant administration with strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products) (see Error! Hyperlink reference not valid. ). Pregnancy and lactation (see Error! Hyperlink reference not valid. and Error! Hyperlink reference not valid. ). Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. Moreover, cholesterol and other products of the cholesterol biosynthesis pathway are essential components for fetal development, including synthesis of steroids and cell membranes. Because of the ability of inhibitors of HMG-CoA reductase such as lovastatin to decrease the synthesis of cholesterol and possibly other products of the cholesterol biosynthesis pathway, lovastatin is contraindicated during pregnancy and in nursing mothers. Lovastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, lovastatin should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus (see Error! Hyperlink reference not valid. ).
Warnings
openFDA Drug LabelingWARNINGS Myopathy/Rhabdomyolysis Lovastatin, like other inhibitors of HMG-CoA reductase, occasionally causes myopathy manifested as muscle pain, tenderness or weakness with creatine kinase (CK) above ten times the upper limit of normal (ULN). Myopathy sometimes takes the form of rhabdomyolysis with or without acute renal failure secondary to myoglobinuria, and rare fatalities have occurred. The risk of myopathy is increased by high levels of HMG-CoA reductase inhibitory activity in plasma. The risk of myopathy/rhabdomyolysis is dose related. In a clinical study (EXCEL) in which patients were carefully monitored and some interacting drugs were excluded, there was one case of myopathy among 4933 patients randomized to lovastatin 20 to 40 mg daily for 48 weeks, and 4 among 1649 patients randomized to 80 mg daily. All patients starting therapy with lovastatin, or whose dose of lovastatin is being increased, should be advised of the risk of myopathy and told to report promptly any unexplained muscle pain, tenderness or weakness particularly if accompanied by malaise or fever or if muscle signs and symptoms persists after discontinuing lovastatin. Lovastatin therapy should be discontinued immediately if myopathy is diagnosed or suspected. In most cases, muscle symptoms and CK increases resolved when treatment was promptly discontinued. Periodic CK determinations may be considered in patients starting therapy with lovastatin or whose dose is being increased, but there is no assurance that such monitoring will prevent myopathy. Many of the patients who have developed rhabdomyolysis on therapy with lovastatin have had complicated medical histories, including renal insufficiency usually as a consequence of long-standing diabetes mellitus. Such patients merit closer monitoring. Lovastatin therapy should be discontinued if markedly elevated CPK levels occur or myopathy is diagnosed or suspected. Lovastatin therapy should also be temporarily withheld in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis, e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; or uncontrolled epilepsy. The risk of myopathy/rhabdomyolysis is increased by concomitant use of lovastatin with the following: Strong inhibitors of CYP3A4 Lovastatin, like several other inhibitors of HMG-CoA reductase, is a substrate of cytochrome P450 3A4 (CYP3A4). Certain drugs which inhibit this metabolic pathway can raise the plasma levels of lovastatin and may increase the risk of myopathy. These include itraconazole, ketoconazole, posaconazole, voriconazole, the macrolide antibiotics erythromycin and clarithromycin, the ketolide antibiotic telithromycin, HIV protease inhibitors, boceprevir, telaprevir, the antidepressant nefazodone, or cobicistat-containing products. Combination of these drugs with lovastatin is contraindicated. If short-term treatment with strong CYP3A4 inhibitors is unavoidable, therapy with lovastatin should be suspended during the course of treatment (see CONTRAINDICATIONS ; PRECAUTIONS, Drug Interactions ). Gemfibrozil The combined use of lovastatin with gemfibrozil should be avoided. Other lipid-lowering drugs (other fibrates or ≥1 g/day of niacin) Caution should be used when prescribing other fibrates or lipid-lowering doses (≥1 g/day) of niacin with lovastatin, as these agents can cause myopathy when given alone. The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations. Cyclosporine The use of lovastatin with cyclosporine should be avoided. Danazol, diltiazem, dronedarone or verapamil with higher doses of lovastatin The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with danazol, diltiazem, dronedarone, or verapamil. The benefits of the use of lo …
Adverse Reactions
openFDA Drug LabelingADVERSE REACTIONS Lovastatin is generally well tolerated; adverse reactions usually have been mild and transient. † Manson, J.M., Freyssinges, C., Ducrocq, M.B., Stephenson, W.P., Postmarketing Surveillance of Lovastatin and Simvastatin Exposure During Pregnancy. Reproductive Toxicology . 10(6):439-446. 1996. Phase III Clinical Studies In Phase III controlled clinical studies involving 613 patients treated with lovastatin, the adverse experience profile was similar to that shown below for the 8,245-patient EXCEL study (see Expanded Clinical Evaluation of Lovastatin [EXCEL] Study ). Persistent increases of serum transaminases have been noted (see WARNINGS , Liver Dysfunction ). About 11% of patients had elevations of CK levels of at least twice the normal value on one or more occasions. The corresponding values for the control agent cholestyramine was 9 percent. This was attributable to the noncardiac fraction of CK. Large increases in CK have sometimes been reported (see WARNINGS , Myopathy/Rhabdomyolysis ). Expanded Clinical Evaluation of Lovastatin (EXCEL) Study Lovastatin was compared to placebo in 8,245 patients with hypercholesterolemia (total-C 240-300 mg/dL [6.2-7.8 mmol/L]) in the randomized, double-blind, parallel, 48-week EXCEL study. Clinical adverse experiences reported as possibly, probably or definitely drug-related in ≥1% in any treatment group are shown in the table below. For no event was the incidence on drug and placebo statistically different. Placebo (N=1663) % Lovastatin 20 mg q.p.m. (N=1642) % Lovastatin 40 mg q.p.m. (N=1645) % Lovastatin 20 mg b.i.d. (N=1646) % Lovastatin 40 mg b.i.d. (N=1649) % Body As a Whole Asthenia 1.4 1.7 1.4 1.5 1.2 Gastrointestinal Abdominal pain 1.6 2.0 2.0 2.2 2.5 Constipation 1.9 2.0 3.2 3.2 3.5 Diarrhea 2.3 2.6 2.4 2.2 2.6 Dyspepsia 1.9 1.3 1.3 1.0 1.6 Flatulence 4.2 3.7 4.3 3.9 4.5 Nausea 2.5 1.9 2.5 2.2 2.2 Musculoskeletal Muscle cramps 0.5 0.6 0.8 1.1 1.0 Myalgia 1.7 2.6 1.8 2.2 3.0 Nervous System/Psychiatric Dizziness 0.7 0.7 1.2 0.5 0.5 Headache 2.7 2.6 2.8 2.1 3.2 Skin Rash 0.7 0.8 1.0 1.2 1.3 Special Senses Blurred vision 0.8 1.1 0.9 0.9 1.2 Other clinical adverse experiences reported as possibly, probably or definitely drug-related in 0.5 to 1.0 percent of patients in any drug-treated group are listed below. In all these cases the incidence on drug and placebo was not statistically different. Body as a Whole: chest pain; Gastrointestinal: acid regurgitation, dry mouth, vomiting; Musculoskeletal: leg pain, shoulder pain, arthralgia; Nervous System/Psychiatric: insomnia, paresthesia; Skin: alopecia, pruritus; Special Senses: eye irritation. In the EXCEL study (see CLINICAL PHARMACOLOGY , Clinical Studies ), 4.6% of the patients treated up to 48 weeks were discontinued due to clinical or laboratory adverse experiences which were rated by the investigator as possibly, probably or definitely related to therapy with lovastatin. The value for the placebo group was 2.5%. Air Force/Texas Coronary Atherosclerosis Prevention Study (AFCAPS/TexCAPS) In AFCAPS/TexCAPS (see CLINICAL PHARMACOLOGY , Clinical Studies ) involving 6,605 participants treated with 20 to 40 mg/day of lovastatin (n=3,304) or placebo (n=3,301), the safety and tolerability profile of the group treated with lovastatin was comparable to that of the group treated with placebo during a median of 5.1 years of follow-up. The adverse experiences reported in AFCAPS/TexCAPS were similar to those reported in EXCEL (see ADVERSE REACTIONS , Expanded Clinical Evaluation of Lovastatin (EXCEL) Study ). Concomitant Therapy In controlled clinical studies in which lovastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with lovastatin or cholestyramine. Other lipid-lowering agents were not administered concomitantly with lovastatin during controlled clinical studies. Pr …
Drug Interactions
openFDA Drug LabelingDrug Interactions CYP3A4 Interactions Lovastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Strong inhibitors of CYP3A4 (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, clarithromycin, telithromycin, HIV protease inhibitors, boceprevir, telaprevir, nefazodone, erythromycin, and cobicistat-containing products), and grapefruit juice increase the risk of myopathy by reducing the elimination of lovastatin (see CONTRAINDICATIONS , WARNINGS , Myopathy/Rhabdomyolysis , and CLINICAL PHARMACOLOGY , Pharmacokinetics ). Interactions With Lipid-Lowering Drugs That Can Cause Myopathy When Given Alone The risk of myopathy is also increased by the following lipid-lowering drugs that are not strong CYP3A4 inhibitors, but which can cause myopathy when given alone. See WARNINGS, Myopathy/Rhabdomyolysis. Gemfibrozil Other fibrates Niacin (nicotinic acid) (≥ 1 g/day) Other Drug Interactions Cyclosporine The risk of myopathy/rhabdomyolysis is increased by concomitant administration of cyclosporine (see WARNINGS , Myopathy/Rhabdomyolysis ). Danazol, Diltiazem, Dronedarone or Verapamil The risk of myopathy/rhabdomyolysis is increased by concomitant administration of danazol, diltiazem, dronedarone or verapamil particularly with higher doses of lovastatin (see WARNINGS , Myopathy/Rhabdomyolysis ; CLINICAL PHARMACOLOGY , Pharmacokinetics ). Amiodarone The risk of myopathy/rhabdomyolysis is increased when amiodarone is used concomitantly with a closely related member of the HMG-CoA reductase inhibitor class (see WARNINGS , Myopathy/Rhabdomyolysis ). Coumarin Anticoagulants In a small clinical trial in which lovastatin was administered to warfarin treated patients, no effect on prothrombin time was detected. However, another HMG-CoA reductase inhibitor has been found to produce a less than two-second increase in prothrombin time in healthy volunteers receiving low doses of warfarin. Also, bleeding and/or increased prothrombin time have been reported in a few patients taking coumarin anticoagulants concomitantly with lovastatin. It is recommended that in patients taking anticoagulants, prothrombin time be determined before starting lovastatin and frequently enough during early therapy to insure that no significant alteration of prothrombin time occurs. Once a stable prothrombin time has been documented, prothrombin times can be monitored at the intervals usually recommended for patients on coumarin anticoagulants. If the dose of lovastatin is changed, the same procedure should be repeated. Lovastatin therapy has not been associated with bleeding or with changes in prothrombin time in patients not taking anticoagulants. Colchicine Cases of myopathy, including rhabdomyolysis, have been reported with lovastatin coadministered with colchicine. See WARNINGS , Myopathy/Rhabdomyolysis . Ranolazine The risk of myopathy, including rhabdomyolysis, may be increased by concomitant administration of ranolazine. See WARNINGS , Myopathy/Rhabdomyolysis . Propranolol In normal volunteers, there was no clinically significant pharmacokinetic or pharmacodynamic interaction with concomitant administration of single doses of lovastatin and propranolol. Digoxin In patients with hypercholesterolemia, concomitant administration of lovastatin and digoxin resulted in no effect on digoxin plasma concentrations. Oral Hypoglycemic Agents In pharmacokinetic studies of lovastatin in hypercholesterolemic non-insulin dependent diabetic patients, there was no drug interaction with glipizide or with chlorpropamide (see CLINICAL PHARMACOLOGY , Clinical Studies in Adults ). Endocrine Function Increases in HbA1c and fasting serum glucose levels have been reported with HMG-CoA reductase inhibitors, including lovastatin. HMG-CoA reductase inhibitors interfere with cholesterol synthesis and as such might theoretically blunt adrenal and/or gonadal steroid produ …
Description
openFDA Drug LabelingDESCRIPTION Lovastatin, USP is a cholesterol lowering agent isolated from a strain of Aspergillus terreus . After oral ingestion, lovastatin, USP, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is a principal metabolite and an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate limiting step in the biosynthesis of cholesterol. Lovastatin, USP is [1 S -[1α( R *),3α,7β,8β(2 S *,4 S *),8aβ]]-1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2 H -pyran-2-yl)ethyl]-1-naphthalenyl 2-methylbutanoate. Its structural formula is: C 24 H 36 O 5 M.W. 404.55 C 24 H 36 O 5 M.W. 404.55 Lovastatin, USP is a white, nonhygroscopic crystalline powder that is insoluble in water and sparingly soluble in ethanol, methanol, and acetonitrile. Lovastatin Tablets USP are supplied as 10 mg, 20 mg and 40 mg tablets for oral administration. In addition to the active ingredient lovastatin, USP, each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized corn starch. Butylated hydroxyanisole (BHA) is added as a preservative. Lovastatin Tablets USP, 10 mg also contain FD&C Yellow #6 Aluminum Lake. Lovastatin Tablets USP, 20 mg also contain FD&C Blue #1 Aluminum Lake. Lovastatin Tablets USP, 40 mg also contain D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, and FD&C Yellow #6 Aluminum Lake. lovastatin structural formula
Overdosage
openFDA Drug LabelingOVERDOSAGE After oral administration of lovastatin to mice, the median lethal dose observed was >15 g / m 2 . Five healthy human volunteers have received up to 200 mg of lovastatin as a single dose without clinically significant adverse experiences. A few cases of accidental overdosage have been reported; no patients had any specific symptoms, and all patients recovered without sequelae. The maximum dose taken was 5 to 6 g. Until further experience is obtained, no specific treatment of overdosage with lovastatin can be recommended. The dialyzability of lovastatin and its metabolites in man is not known at present.
How Supplied / Storage and Handling
openFDA Drug LabelingHOW SUPPLIED Lovastatin Tablets USP (white to off white round, unscored tablets) containing 10mg of lovastatin and engraved with “CTI 141" Bottle of 30..................................................................................................................................(NDC 71205-992-30) Bottle of 60..................................................................................................................................(NDC 71205-992-60) Bottle of 90................................................................................................................................(NDC 71205-992-90) Bottle of 100................................................................................................................................(NDC 71205-992-00) Bottle of 500.............................................................................................................................(NDC 71205-992-55) Bottle of 1000.............................................................................................................................(NDC 71205-992-11) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 20mg of lovastatin and engraved with “CTI 142” Bottle of 30..................................................................................................................................(NDC 71205-993-30) Bottle of 60..................................................................................................................................(NDC 71205-993-60) Bottle of 90................................................................................................................................(NDC 71205-993-90) Bottle of 100................................................................................................................................(NDC 71205-993-00) Bottle of 500.............................................................................................................................(NDC 71205-993-55) Bottle of 1000.............................................................................................................................(NDC 71205-993-11) Lovastatin Tablets USP (white to off white round, unscored tablets) containing 40mg of lovastatin and engraved with “CTI 143” Bottle of 30..................................................................................................................................(NDC 71205-994-30) Bottle of 60..................................................................................................................................(NDC 71205-994-60) Bottle of 90................................................................................................................................(NDC 71205-994-90) Bottle of 100................................................................................................................................(NDC 71205-994-00) Bottle of 500.............................................................................................................................(NDC 71205-994-55) Bottle of 1000.............................................................................................................................(NDC 71205-994-11) ____________________________________ 4 National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics . 89(3):495-501, 1992. Storage Store at 20o to 25o C (68o to 77o F). [See USP Controlled Room Temperature.] Lovastatin Tablets must be protected from light and stored in a well-closed, light-resistant container. Manufactured and Distributed By: Carlsbad Tech 5928 Farnsworth Court Carlsbad, CA 92008 Repackaged and Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320 Revised: March 2017 CTI-13 Rev. J
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: LOVASTATIN. 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 III | August 14, 2019 | American Health Packaging | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | Terminated |
| Class III | February 27, 2019 | Lupin Pharmaceuticals Inc. | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results. | Terminated |
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 50090-0759-0 | 50090-0759 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0759-0) | November 28, 2014 |
| 50090-0759-2 | 50090-0759 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-0759-2) | November 28, 2014 |
| 50090-0761-0 | 50090-0761 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0761-0) | November 28, 2014 |
| 50090-0761-2 | 50090-0761 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-0761-2) | October 14, 2019 |
| 50090-0762-0 | 50090-0762 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-0762-0) | November 28, 2014 |
| 50090-0762-2 | 50090-0762 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-0762-2) | November 28, 2014 |
| 50090-3268-0 | 50090-3268 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-3268-0) | April 6, 2018 |
| 50090-3268-1 | 50090-3268 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3268-1) | November 17, 2017 |
| 50090-3396-0 | 50090-3396 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-3396-0) | October 9, 2019 |
| 50090-3396-1 | 50090-3396 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE (50090-3396-1) | March 12, 2018 |
| 50090-3881-0 | 50090-3881 | A-S Medication Solutions | 30 TABLET in 1 BOTTLE (50090-3881-0) | November 28, 2018 |
| 50090-3881-2 | 50090-3881 | A-S Medication Solutions | 90 TABLET in 1 BOTTLE, PLASTIC (50090-3881-2) | November 28, 2014 |
| 71610-709-45 | 71610-709 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE (71610-709-45) | May 31, 2023 |
| 71610-775-30 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (71610-775-30) | January 22, 2024 |
| 71610-775-45 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | 45 TABLET in 1 BOTTLE, PLASTIC (71610-775-45) | January 22, 2024 |
| 71610-775-53 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | 60 TABLET in 1 BOTTLE, PLASTIC (71610-775-53) | January 22, 2024 |
| 71610-775-60 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (71610-775-60) | January 22, 2024 |
| 71610-775-80 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | 180 TABLET in 1 BOTTLE, PLASTIC (71610-775-80) | January 22, 2024 |
| 68001-314-00 | 68001-314 | BluePoint Laboratories | 100 TABLET in 1 BOTTLE (68001-314-00) | February 7, 2017 |
| 68001-314-08 | 68001-314 | BluePoint Laboratories | 1000 TABLET in 1 BOTTLE (68001-314-08) | February 7, 2017 |
| 68001-315-00 | 68001-315 | BluePoint Laboratories | 100 TABLET in 1 BOTTLE (68001-315-00) | February 7, 2017 |
| 68001-315-08 | 68001-315 | BluePoint Laboratories | 1000 TABLET in 1 BOTTLE (68001-315-08) | February 7, 2017 |
| 68001-316-00 | 68001-316 | BluePoint Laboratories | 100 TABLET in 1 BOTTLE (68001-316-00) | February 7, 2017 |
| 68001-316-08 | 68001-316 | BluePoint Laboratories | 1000 TABLET in 1 BOTTLE (68001-316-08) | February 7, 2017 |
| 83209-143-30 | 83209-143 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 TABLET in 1 BLISTER PACK (83209-143-30) | February 25, 2025 |
| 83209-468-30 | 83209-468 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 30 TABLET in 1 BLISTER PACK (83209-468-30) | February 24, 2025 |
| 63629-1018-0 | 63629-1018 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (63629-1018-0) | August 14, 2024 |
| 63629-1018-1 | 63629-1018 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1018-1) | August 14, 2024 |
| 63629-1018-2 | 63629-1018 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-1018-2) | August 14, 2024 |
| 63629-1018-3 | 63629-1018 | Bryant Ranch Prepack | 300 TABLET in 1 BOTTLE (63629-1018-3) | August 14, 2024 |
| 63629-1018-4 | 63629-1018 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (63629-1018-4) | December 16, 2019 |
| 63629-1018-5 | 63629-1018 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (63629-1018-5) | December 10, 2019 |
| 63629-1018-6 | 63629-1018 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-1018-6) | August 14, 2024 |
| 63629-1018-8 | 63629-1018 | Bryant Ranch Prepack | 800 TABLET in 1 BOTTLE (63629-1018-8) | August 14, 2024 |
| 63629-1018-9 | 63629-1018 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-1018-9) | August 14, 2024 |
| 63629-1178-1 | 63629-1178 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1178-1) | November 25, 2002 |
| 63629-1191-1 | 63629-1191 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (63629-1191-1) | November 25, 2002 |
| 63629-1464-1 | 63629-1464 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-1464-1) | January 26, 2005 |
| 63629-1464-2 | 63629-1464 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-1464-2) | September 30, 2009 |
| 63629-1464-3 | 63629-1464 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-1464-3) | January 19, 2009 |
| 63629-1464-4 | 63629-1464 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-1464-4) | June 12, 2012 |
| 63629-1464-5 | 63629-1464 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-1464-5) | December 26, 2018 |
| 63629-3583-1 | 63629-3583 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (63629-3583-1) | June 28, 2007 |
| 63629-3583-2 | 63629-3583 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (63629-3583-2) | April 27, 2018 |
| 63629-3583-3 | 63629-3583 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (63629-3583-3) | August 9, 2011 |
| 63629-3583-4 | 63629-3583 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (63629-3583-4) | January 3, 2012 |
| 63629-3583-5 | 63629-3583 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (63629-3583-5) | December 26, 2018 |
| 71335-0045-1 | 71335-0045 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0045-1) | June 19, 2018 |
| 71335-0045-2 | 71335-0045 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0045-2) | April 27, 2018 |
| 71335-0045-3 | 71335-0045 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0045-3) | June 4, 2018 |
| 71335-0819-1 | 71335-0819 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0819-1) | May 8, 2018 |
| 71335-0819-2 | 71335-0819 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (71335-0819-2) | April 4, 2024 |
| 71335-0819-3 | 71335-0819 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0819-3) | April 4, 2024 |
| 71335-0819-4 | 71335-0819 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0819-4) | June 22, 2018 |
| 71335-0819-5 | 71335-0819 | Bryant Ranch Prepack | 20 TABLET in 1 BOTTLE (71335-0819-5) | April 4, 2024 |
| 71335-0882-1 | 71335-0882 | Bryant Ranch Prepack | 30 TABLET in 1 BOTTLE (71335-0882-1) | April 4, 2024 |
| 71335-0882-2 | 71335-0882 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (71335-0882-2) | April 4, 2024 |
| 71335-0882-3 | 71335-0882 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (71335-0882-3) | June 22, 2018 |
| 72162-1739-0 | 72162-1739 | Bryant Ranch Prepack | 1000 TABLET in 1 BOTTLE (72162-1739-0) | August 12, 2024 |
| 72162-1739-2 | 72162-1739 | Bryant Ranch Prepack | 100 TABLET in 1 BOTTLE (72162-1739-2) | August 12, 2024 |
| 72162-1739-4 | 72162-1739 | Bryant Ranch Prepack | 300 TABLET in 1 BOTTLE (72162-1739-4) | August 12, 2024 |
| 72162-1739-5 | 72162-1739 | Bryant Ranch Prepack | 500 TABLET in 1 BOTTLE (72162-1739-5) | August 12, 2024 |
| 72162-1739-6 | 72162-1739 | Bryant Ranch Prepack | 60 TABLET in 1 BOTTLE (72162-1739-6) | August 12, 2024 |
| 72162-1739-7 | 72162-1739 | Bryant Ranch Prepack | 120 TABLET in 1 BOTTLE (72162-1739-7) | August 12, 2024 |
| 72162-1739-9 | 72162-1739 | Bryant Ranch Prepack | 90 TABLET in 1 BOTTLE (72162-1739-9) | August 12, 2024 |
| 61442-141-01 | 61442-141 | Carlsbad Technology, Inc. | 100 TABLET in 1 BOTTLE (61442-141-01) | November 25, 2002 |
| 61442-141-05 | 61442-141 | Carlsbad Technology, Inc. | 500 TABLET in 1 BOTTLE (61442-141-05) | November 25, 2002 |
| 61442-141-10 | 61442-141 | Carlsbad Technology, Inc. | 1000 TABLET in 1 BOTTLE (61442-141-10) | November 25, 2002 |
| 61442-141-60 | 61442-141 | Carlsbad Technology, Inc. | 60 TABLET in 1 BOTTLE (61442-141-60) | November 25, 2002 |
| 61442-142-01 | 61442-142 | Carlsbad Technology, Inc. | 100 TABLET in 1 BOTTLE (61442-142-01) | November 25, 2002 |
| 61442-142-05 | 61442-142 | Carlsbad Technology, Inc. | 500 TABLET in 1 BOTTLE (61442-142-05) | November 25, 2002 |
| 61442-142-10 | 61442-142 | Carlsbad Technology, Inc. | 1000 TABLET in 1 BOTTLE (61442-142-10) | November 25, 2002 |
| 61442-142-60 | 61442-142 | Carlsbad Technology, Inc. | 60 TABLET in 1 BOTTLE (61442-142-60) | November 25, 2002 |
| 61442-143-01 | 61442-143 | Carlsbad Technology, Inc. | 100 TABLET in 1 BOTTLE (61442-143-01) | November 25, 2002 |
| 61442-143-05 | 61442-143 | Carlsbad Technology, Inc. | 500 TABLET in 1 BOTTLE (61442-143-05) | November 25, 2002 |
| 61442-143-10 | 61442-143 | Carlsbad Technology, Inc. | 1000 TABLET in 1 BOTTLE (61442-143-10) | November 25, 2002 |
| 61442-143-60 | 61442-143 | Carlsbad Technology, Inc. | 60 TABLET in 1 BOTTLE (61442-143-60) | November 25, 2002 |
| 51407-251-10 | 51407-251 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-251-10) | August 20, 2019 |
| 51407-252-10 | 51407-252 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-252-10) | August 20, 2019 |
| 51407-253-10 | 51407-253 | Golden State Medical Supply, Inc. | 1000 TABLET in 1 BOTTLE (51407-253-10) | August 20, 2019 |
| 68645-566-90 | 68645-566 | Legacy Pharmaceutical Packaging, LLC | 90 TABLET in 1 BOTTLE (68645-566-90) | November 1, 2007 |
| 68645-567-90 | 68645-567 | Legacy Pharmaceutical Packaging, LLC | 90 TABLET in 1 BOTTLE (68645-567-90) | November 1, 2007 |
| 68180-467-01 | 68180-467 | Lupin Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68180-467-01) | March 14, 2008 |
| 68180-467-03 | 68180-467 | Lupin Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (68180-467-03) | March 14, 2008 |
| 68180-467-07 | 68180-467 | Lupin Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68180-467-07) | March 14, 2008 |
| 68180-467-09 | 68180-467 | Lupin Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68180-467-09) | June 4, 2019 |
| 68180-468-01 | 68180-468 | Lupin Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68180-468-01) | November 1, 2007 |
| 68180-468-03 | 68180-468 | Lupin Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (68180-468-03) | November 1, 2007 |
| 68180-468-05 | 68180-468 | Lupin Pharmaceuticals, Inc. | 5000 TABLET in 1 BOTTLE (68180-468-05) | November 1, 2007 |
| 68180-468-07 | 68180-468 | Lupin Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68180-468-07) | November 1, 2007 |
| 68180-469-01 | 68180-469 | Lupin Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68180-469-01) | November 1, 2007 |
| 68180-469-03 | 68180-469 | Lupin Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE (68180-469-03) | November 1, 2007 |
| 68180-469-05 | 68180-469 | Lupin Pharmaceuticals, Inc. | 5000 TABLET in 1 BOTTLE (68180-469-05) | November 1, 2007 |
| 68180-469-07 | 68180-469 | Lupin Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68180-469-07) | November 1, 2007 |
| 0615-8151-39 | 0615-8151 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8151-39) | July 9, 2018 |
| 0615-8152-39 | 0615-8152 | NCS HealthCare of KY, LLC dba Vangard Labs | 30 TABLET in 1 BLISTER PACK (0615-8152-39) | July 10, 2018 |
| 51655-469-26 | 51655-469 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-469-26) | March 22, 2023 |
| 51655-469-52 | 51655-469 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-469-52) | November 30, 2022 |
| 51655-558-26 | 51655-558 | Northwind Health Company, LLC | 90 TABLET in 1 BOTTLE, PLASTIC (51655-558-26) | January 25, 2021 |
| 51655-558-52 | 51655-558 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-558-52) | February 20, 2023 |
| 51655-686-52 | 51655-686 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-686-52) | April 1, 2021 |
| 51655-873-52 | 51655-873 | Northwind Health Company, LLC | 30 TABLET in 1 BOTTLE, PLASTIC (51655-873-52) | April 10, 2023 |
| 66267-506-30 | 66267-506 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (66267-506-30) | November 15, 2016 |
| 66267-506-90 | 66267-506 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (66267-506-90) | November 15, 2016 |
| 66267-561-30 | 66267-561 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (66267-561-30) | December 22, 2016 |
| 66267-561-90 | 66267-561 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (66267-561-90) | December 22, 2016 |
| 68071-3127-3 | 68071-3127 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68071-3127-3) | March 13, 2017 |
| 68071-3127-6 | 68071-3127 | NuCare Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68071-3127-6) | March 13, 2017 |
| 68071-3127-9 | 68071-3127 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68071-3127-9) | March 13, 2017 |
| 68071-3261-3 | 68071-3261 | NuCare Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68071-3261-3) | May 22, 2017 |
| 68071-3261-6 | 68071-3261 | NuCare Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68071-3261-6) | May 22, 2017 |
| 68071-3261-9 | 68071-3261 | NuCare Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68071-3261-9) | May 22, 2017 |
| 68071-3615-1 | 68071-3615 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3615-1) | May 30, 2024 |
| 68071-3622-1 | 68071-3622 | NuCare Pharmaceuticals,Inc. | 100 TABLET in 1 BOTTLE (68071-3622-1) | June 13, 2024 |
| 68071-4955-3 | 68071-4955 | NuCare Pharmaceuticals,Inc. | 30 TABLET in 1 BOTTLE (68071-4955-3) | July 3, 2019 |
| 43063-548-14 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (43063-548-14) | November 15, 2014 |
| 43063-548-30 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-548-30) | November 15, 2014 |
| 43063-548-90 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-548-90) | November 15, 2014 |
| 43063-548-93 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (43063-548-93) | December 24, 2014 |
| 43063-548-95 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (43063-548-95) | September 16, 2022 |
| 43063-692-30 | 43063-692 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-692-30) | July 31, 2023 |
| 43063-692-90 | 43063-692 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (43063-692-90) | July 26, 2016 |
| 43063-692-93 | 43063-692 | PD-Rx Pharmaceuticals, Inc. | 180 TABLET in 1 BOTTLE, PLASTIC (43063-692-93) | July 26, 2016 |
| 43063-692-95 | 43063-692 | PD-Rx Pharmaceuticals, Inc. | 1000 TABLET in 1 BOTTLE, PLASTIC (43063-692-95) | October 3, 2022 |
| 43063-939-30 | 43063-939 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-939-30) | January 29, 2019 |
| 43063-983-30 | 43063-983 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (43063-983-30) | May 7, 2019 |
| 55289-692-14 | 55289-692 | PD-Rx Pharmaceuticals, Inc. | 14 TABLET in 1 BOTTLE, PLASTIC (55289-692-14) | October 27, 2010 |
| 55289-692-30 | 55289-692 | PD-Rx Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE, PLASTIC (55289-692-30) | October 27, 2010 |
| 55289-692-90 | 55289-692 | PD-Rx Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE, PLASTIC (55289-692-90) | October 27, 2010 |
| 68788-7056-1 | 68788-7056 | Preferred Pharmaceuticals Inc. | 100 TABLET in 1 BOTTLE (68788-7056-1) | January 5, 2018 |
| 68788-7056-3 | 68788-7056 | Preferred Pharmaceuticals Inc. | 30 TABLET in 1 BOTTLE (68788-7056-3) | January 5, 2018 |
| 68788-7056-6 | 68788-7056 | Preferred Pharmaceuticals Inc. | 60 TABLET in 1 BOTTLE (68788-7056-6) | January 5, 2018 |
| 68788-7056-9 | 68788-7056 | Preferred Pharmaceuticals Inc. | 90 TABLET in 1 BOTTLE (68788-7056-9) | January 5, 2018 |
| 68788-8232-3 | 68788-8232 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-8232-3) | August 8, 2022 |
| 68788-8326-1 | 68788-8326 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-8326-1) | January 19, 2023 |
| 68788-8326-3 | 68788-8326 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-8326-3) | January 19, 2023 |
| 68788-8326-6 | 68788-8326 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-8326-6) | January 19, 2023 |
| 68788-8326-9 | 68788-8326 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-8326-9) | January 19, 2023 |
| 68788-9667-1 | 68788-9667 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-9667-1) | July 29, 2013 |
| 68788-9667-3 | 68788-9667 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-9667-3) | July 29, 2013 |
| 68788-9667-6 | 68788-9667 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-9667-6) | July 29, 2013 |
| 68788-9667-9 | 68788-9667 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-9667-9) | July 29, 2013 |
| 68788-9668-1 | 68788-9668 | Preferred Pharmaceuticals, Inc. | 100 TABLET in 1 BOTTLE (68788-9668-1) | July 29, 2013 |
| 68788-9668-3 | 68788-9668 | Preferred Pharmaceuticals, Inc. | 30 TABLET in 1 BOTTLE (68788-9668-3) | July 29, 2013 |
| 68788-9668-6 | 68788-9668 | Preferred Pharmaceuticals, Inc. | 60 TABLET in 1 BOTTLE (68788-9668-6) | July 29, 2013 |
| 68788-9668-9 | 68788-9668 | Preferred Pharmaceuticals, Inc. | 90 TABLET in 1 BOTTLE (68788-9668-9) | July 29, 2013 |
| 63187-090-30 | 63187-090 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-090-30) | November 1, 2018 |
| 63187-090-60 | 63187-090 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-090-60) | November 1, 2018 |
| 63187-090-90 | 63187-090 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-090-90) | November 1, 2018 |
| 63187-194-30 | 63187-194 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-194-30) | February 2, 2015 |
| 63187-194-60 | 63187-194 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-194-60) | February 2, 2015 |
| 63187-194-90 | 63187-194 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-194-90) | February 2, 2015 |
| 63187-345-30 | 63187-345 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-345-30) | January 1, 2019 |
| 63187-345-60 | 63187-345 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-345-60) | January 1, 2019 |
| 63187-345-90 | 63187-345 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-345-90) | January 1, 2019 |
| 63187-765-30 | 63187-765 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-765-30) | November 1, 2016 |
| 63187-765-60 | 63187-765 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-765-60) | November 1, 2016 |
| 63187-765-90 | 63187-765 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-765-90) | November 1, 2016 |
| 63187-814-30 | 63187-814 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (63187-814-30) | February 1, 2017 |
| 63187-814-60 | 63187-814 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (63187-814-60) | February 1, 2017 |
| 63187-814-90 | 63187-814 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (63187-814-90) | February 1, 2017 |
| 71205-199-30 | 71205-199 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-199-30) | January 1, 2019 |
| 71205-199-60 | 71205-199 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-199-60) | January 1, 2019 |
| 71205-199-90 | 71205-199 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-199-90) | January 1, 2019 |
| 71205-440-30 | 71205-440 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-440-30) | April 1, 2020 |
| 71205-440-60 | 71205-440 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-440-60) | April 1, 2020 |
| 71205-440-90 | 71205-440 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-440-90) | April 1, 2020 |
| 71205-992-00 | 71205-992 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-992-00) | April 1, 2020 |
| 71205-992-11 | 71205-992 | Proficient Rx LP | 1000 TABLET in 1 BOTTLE (71205-992-11) | April 1, 2020 |
| 71205-992-30 | 71205-992 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-992-30) | April 1, 2020 |
| 71205-992-55 | 71205-992 | Proficient Rx LP | 500 TABLET in 1 BOTTLE (71205-992-55) | April 1, 2020 |
| 71205-992-60 | 71205-992 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-992-60) | April 1, 2020 |
| 71205-992-90 | 71205-992 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-992-90) | April 1, 2020 |
| 71205-993-00 | 71205-993 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-993-00) | April 1, 2020 |
| 71205-993-11 | 71205-993 | Proficient Rx LP | 1000 TABLET in 1 BOTTLE (71205-993-11) | April 1, 2020 |
| 71205-993-30 | 71205-993 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-993-30) | April 1, 2020 |
| 71205-993-55 | 71205-993 | Proficient Rx LP | 500 TABLET in 1 BOTTLE (71205-993-55) | April 1, 2020 |
| 71205-993-60 | 71205-993 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-993-60) | April 1, 2020 |
| 71205-993-90 | 71205-993 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-993-90) | April 1, 2020 |
| 71205-994-00 | 71205-994 | Proficient Rx LP | 100 TABLET in 1 BOTTLE (71205-994-00) | April 1, 2020 |
| 71205-994-11 | 71205-994 | Proficient Rx LP | 1000 TABLET in 1 BOTTLE (71205-994-11) | April 1, 2020 |
| 71205-994-30 | 71205-994 | Proficient Rx LP | 30 TABLET in 1 BOTTLE (71205-994-30) | April 1, 2020 |
| 71205-994-55 | 71205-994 | Proficient Rx LP | 500 TABLET in 1 BOTTLE (71205-994-55) | April 1, 2020 |
| 71205-994-60 | 71205-994 | Proficient Rx LP | 60 TABLET in 1 BOTTLE (71205-994-60) | April 1, 2020 |
| 71205-994-90 | 71205-994 | Proficient Rx LP | 90 TABLET in 1 BOTTLE (71205-994-90) | April 1, 2020 |
| 70518-2009-0 | 70518-2009 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2009-0) | April 11, 2019 |
| 70518-2009-1 | 70518-2009 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-2009-1) | October 26, 2021 |
| 70518-2425-1 | 70518-2425 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-2425-1) | August 26, 2025 |
| 70518-3064-0 | 70518-3064 | REMEDYREPACK INC. | 90 TABLET in 1 BOTTLE, PLASTIC (70518-3064-0) | April 2, 2021 |
| 70518-3064-1 | 70518-3064 | REMEDYREPACK INC. | 30 TABLET in 1 BLISTER PACK (70518-3064-1) | May 12, 2021 |
| 0093-0576-06 | 0093-0576 | Teva Pharmaceuticals USA, Inc. | 60 TABLET in 1 BOTTLE (0093-0576-06) | December 17, 2001 |
| 0093-0576-10 | 0093-0576 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (0093-0576-10) | December 17, 2001 |
| 0093-0926-06 | 0093-0926 | Teva Pharmaceuticals USA, Inc. | 60 TABLET in 1 BOTTLE (0093-0926-06) | December 17, 2001 |
| 0093-0926-10 | 0093-0926 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (0093-0926-10) | December 17, 2001 |
| 0093-0928-06 | 0093-0928 | Teva Pharmaceuticals USA, Inc. | 60 TABLET in 1 BOTTLE (0093-0928-06) | December 17, 2001 |
| 0093-0928-10 | 0093-0928 | Teva Pharmaceuticals USA, Inc. | 1000 TABLET in 1 BOTTLE (0093-0928-10) | December 17, 2001 |
| 50090-0759 | 50090-0759 | A-S Medication Solutions | — | November 1, 2007 |
| 50090-0761 | 50090-0761 | A-S Medication Solutions | — | November 25, 2002 |
| 50090-0762 | 50090-0762 | A-S Medication Solutions | — | November 1, 2007 |
| 50090-3268 | 50090-3268 | A-S Medication Solutions | — | December 17, 2001 |
| 50090-3396 | 50090-3396 | A-S Medication Solutions | — | March 14, 2008 |
| 50090-3881 | 50090-3881 | A-S Medication Solutions | — | November 25, 2002 |
| 71610-709 | 71610-709 | Aphena Pharma Solutions - Tennessee, LLC | — | December 17, 2001 |
| 71610-775 | 71610-775 | Aphena Pharma Solutions - Tennessee, LLC | — | November 25, 2002 |
| 68001-314 | 68001-314 | BluePoint Laboratories | — | November 1, 2007 |
| 68001-315 | 68001-315 | BluePoint Laboratories | — | November 1, 2007 |
| 68001-316 | 68001-316 | BluePoint Laboratories | — | November 1, 2007 |
| 83209-143 | 83209-143 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | — | February 25, 2025 |
| 83209-468 | 83209-468 | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | — | February 24, 2025 |
| 63629-1018 | 63629-1018 | Bryant Ranch Prepack | — | November 25, 2002 |
| 63629-1178 | 63629-1178 | Bryant Ranch Prepack | — | November 25, 2002 |
| 63629-1191 | 63629-1191 | Bryant Ranch Prepack | — | November 25, 2002 |
| 63629-1464 | 63629-1464 | Bryant Ranch Prepack | — | November 25, 2002 |
| 63629-3583 | 63629-3583 | Bryant Ranch Prepack | — | November 25, 2002 |
| 71335-0045 | 71335-0045 | Bryant Ranch Prepack | — | November 25, 2002 |
| 71335-0819 | 71335-0819 | Bryant Ranch Prepack | — | November 1, 2007 |
| 71335-0882 | 71335-0882 | Bryant Ranch Prepack | — | November 1, 2007 |
| 72162-1739 | 72162-1739 | Bryant Ranch Prepack | — | November 25, 2002 |
| 61442-141 | 61442-141 | Carlsbad Technology, Inc. | — | November 25, 2002 |
| 61442-142 | 61442-142 | Carlsbad Technology, Inc. | — | November 25, 2002 |
| 61442-143 | 61442-143 | Carlsbad Technology, Inc. | — | November 25, 2002 |
| 51407-251 | 51407-251 | Golden State Medical Supply, Inc. | — | December 17, 2001 |
| 51407-252 | 51407-252 | Golden State Medical Supply, Inc. | — | December 17, 2001 |
| 51407-253 | 51407-253 | Golden State Medical Supply, Inc. | — | December 17, 2001 |
| 68645-566 | 68645-566 | Legacy Pharmaceutical Packaging, LLC | — | November 1, 2007 |
| 68645-567 | 68645-567 | Legacy Pharmaceutical Packaging, LLC | — | November 1, 2007 |
| 68180-467 | 68180-467 | Lupin Pharmaceuticals, Inc. | — | March 14, 2008 |
| 68180-468 | 68180-468 | Lupin Pharmaceuticals, Inc. | — | November 1, 2007 |
| 68180-469 | 68180-469 | Lupin Pharmaceuticals, Inc. | — | November 1, 2007 |
| 0615-8151 | 0615-8151 | NCS HealthCare of KY, LLC dba Vangard Labs | — | July 9, 2018 |
| 0615-8152 | 0615-8152 | NCS HealthCare of KY, LLC dba Vangard Labs | — | July 10, 2018 |
| 51655-469 | 51655-469 | Northwind Health Company, LLC | — | November 30, 2022 |
| 51655-558 | 51655-558 | Northwind Health Company, LLC | — | January 25, 2021 |
| 51655-686 | 51655-686 | Northwind Health Company, LLC | — | April 1, 2021 |
| 51655-873 | 51655-873 | Northwind Health Company, LLC | — | April 10, 2023 |
| 66267-506 | 66267-506 | NuCare Pharmaceuticals, Inc. | — | November 25, 2002 |
| 66267-561 | 66267-561 | NuCare Pharmaceuticals, Inc. | — | November 25, 2002 |
| 68071-3127 | 68071-3127 | NuCare Pharmaceuticals, Inc. | — | November 25, 2002 |
| 68071-3261 | 68071-3261 | NuCare Pharmaceuticals, Inc. | — | November 1, 2007 |
| 68071-3615 | 68071-3615 | NuCare Pharmaceuticals,Inc. | — | November 1, 2007 |
| 68071-3622 | 68071-3622 | NuCare Pharmaceuticals,Inc. | — | March 14, 2008 |
| 68071-4955 | 68071-4955 | NuCare Pharmaceuticals,Inc. | — | November 25, 2002 |
| 43063-548 | 43063-548 | PD-Rx Pharmaceuticals, Inc. | — | November 25, 2002 |
| 43063-692 | 43063-692 | PD-Rx Pharmaceuticals, Inc. | — | November 25, 2002 |
| 43063-939 | 43063-939 | PD-Rx Pharmaceuticals, Inc. | — | November 25, 2002 |
| 43063-983 | 43063-983 | PD-Rx Pharmaceuticals, Inc. | — | November 25, 2002 |
| 55289-692 | 55289-692 | PD-Rx Pharmaceuticals, Inc. | — | November 1, 2007 |
| 68788-7056 | 68788-7056 | Preferred Pharmaceuticals Inc. | — | January 5, 2018 |
| 68788-8232 | 68788-8232 | Preferred Pharmaceuticals, Inc. | — | August 8, 2022 |
| 68788-8326 | 68788-8326 | Preferred Pharmaceuticals, Inc. | — | January 19, 2023 |
| 68788-9667 | 68788-9667 | Preferred Pharmaceuticals, Inc. | — | July 29, 2013 |
| 68788-9668 | 68788-9668 | Preferred Pharmaceuticals, Inc. | — | July 29, 2013 |
| 63187-090 | 63187-090 | Proficient Rx LP | — | November 25, 2002 |
| 63187-194 | 63187-194 | Proficient Rx LP | — | November 25, 2002 |
| 63187-345 | 63187-345 | Proficient Rx LP | — | November 25, 2002 |
| 63187-765 | 63187-765 | Proficient Rx LP | — | November 1, 2007 |
| 63187-814 | 63187-814 | Proficient Rx LP | — | November 1, 2007 |
| 71205-199 | 71205-199 | Proficient Rx LP | — | November 1, 2007 |
| 71205-440 | 71205-440 | Proficient Rx LP | — | December 17, 2001 |
| 71205-992 | 71205-992 | Proficient Rx LP | — | November 25, 2002 |
| 71205-993 | 71205-993 | Proficient Rx LP | — | November 25, 2002 |
| 71205-994 | 71205-994 | Proficient Rx LP | — | November 25, 2002 |
| 70518-2009 | 70518-2009 | REMEDYREPACK INC. | — | April 11, 2019 |
| 70518-2425 | 70518-2425 | REMEDYREPACK INC. | — | November 18, 2019 |
| 70518-3064 | 70518-3064 | REMEDYREPACK INC. | — | April 2, 2021 |
| 0093-0576 | 0093-0576 | Teva Pharmaceuticals USA, Inc. | — | December 17, 2001 |
| 0093-0926 | 0093-0926 | Teva Pharmaceuticals USA, Inc. | — | December 17, 2001 |
| 0093-0928 | 0093-0928 | Teva Pharmaceuticals USA, Inc. | — | December 17, 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 · 12 sections on this page.