FDA.reportPublic FDA data

Lovastatin

Product NDC
10544-246
11-digit product format
105440246
Labeler code
10544
Product ID
10544-246_531d78b5-f3ba-4430-b6ad-85cabeb7d058
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA075828
Marketing category
ANDA
Marketing start
2010-06-22
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 productproduct10544-246IInactivated by FDA2026-07-31
excluded packagepackage10544-24610544-246-30IInactivated by FDA2026-07-31

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 Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508
f1ae760e-e8ec-b0b4-fb1b-2db7c49fcec5Product name120140508
fecc3d5d-ff9a-60ad-1a3a-6cb9b21df758Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-246-302020-01-31C16284748780-19d75b9d1-2a63-f424-e053-dadaa90a57ceLOVASTATIN TABLETS, USP 40-8843 Revised – January 2008 Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-246-30Lovastatin30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-246-30EA - Each10544-24648fedad1-4588-4b81-b5b7-56ce63d8501712015-11-12

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-246LOVASTATIN TABLET [BLENHEIM PHARMACAL, INC.]2Legacy NDC, 1 package rows20151022_f0251754-a956-4e62-94b7-e4dd15445f8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNf0251754-a956-4e62-94b7-e4dd15445f8c2
197904lovastatin 20 MG Oral TabletSCDf0251754-a956-4e62-94b7-e4dd15445f8c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-246-301054402463030 in 1 BOTTLEHistorical