FDA.reportPublic FDA data

Lovastatin

Product NDC
0615-5589
11-digit product format
006155589
Labeler code
0615
Product ID
0615-5589_0466fea6-e576-4c71-943e-9ec5038f79a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA075828
Marketing category
ANDA
Marketing start
2001-12-17
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-5589DDiscontinued by firm2026-07-31
excluded packagepackage0615-55890615-5589-31DDiscontinued by firm2026-07-31
excluded packagepackage0615-55890615-5589-39DDiscontinued by firm2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075828-001LOVASTATINLOVASTATIN10MGTABLET / ORALAB2001-12-17
A075828-002LOVASTATINLOVASTATIN20MGTABLET / ORALAB2001-12-17
A075828-003LOVASTATINLOVASTATIN40MGTABLET / ORALAB2001-12-17

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A075828-001AB
A075828-002AB
A075828-003AB

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-5589-312021-07-09C16284748780-1960f7f55-cab8-8e05-e053-dbdaa90a074aLOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only
0615-5589-392021-07-09C16284748780-1960f7f55-cab8-8e05-e053-dbdaa90a074aLOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only
0615-5589-312019-10-29C16284748780-1960f7f55-cab8-8e05-e053-dbdaa90a074aLOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only
0615-5589-392019-10-29C16284748780-1960f7f55-cab8-8e05-e053-dbdaa90a074aLOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2