Lovastatin

Product NDC
60429-401
11-digit product format
604290401
Labeler code
60429
Product ID
60429-401_c9eebb1d-94dd-dd54-e053-2a95a90a9a0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
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
No
Listing certified through
2022-12-31
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 productproduct60429-401DDiscontinued by firm2026-07-31
excluded packagepackage60429-40160429-401-10DDiscontinued by firm2026-07-31
excluded packagepackage60429-40160429-401-60DDiscontinued by firm2026-07-31
excluded packagepackage60429-40160429-401-90DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-401-10EA - Each60429-4014bfef76d-bc63-4a19-9543-6acf7aa8a08412015-01-05
60429-401-60EA - Each60429-4017010baed-5619-456e-bc3c-519c1a9e8b6312015-01-05
60429-401-90EA - Each60429-401fd1d4354-7b56-431a-bc10-be375906e1b012015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-401-10604290401101000 TABLET in 1 BOTTLE (60429-401-10) 1000 tablet2014-06-240000-00-00NoNoCurrent
60429-401-606042904016060 TABLET in 1 BOTTLE (60429-401-60) 60 tablet2014-06-240000-00-00NoNoCurrent
60429-401-906042904019090 TABLET in 1 BOTTLE (60429-401-90) 90 tablet2014-06-240000-00-00NoNoCurrent