FDA.reportPublic FDA data

Lovastatin

Product NDC
50090-0762
11-digit product format
500900762
Labeler code
50090
Product ID
50090-0762_78234f1b-b888-4c09-a204-1b18d6af1f0a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
Substance
LOVASTATIN
Active strength
40 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Lovastatin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904, 197905

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
50090-0762-02023-02-06C16284748780-1f386c649-ca0b-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
50090-0762-22023-02-06C16284748780-1f386c649-ca0b-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
50090-0762-02023-01-30C16284748780-1f386c649-ca0b-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
50090-0762-22023-01-30C16284748780-1f386c649-ca0b-0266-e053-dadaa90a7c1aLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0762-0Lovastatin30 in 1 BOTTLETABLET3018
50090-0762-2Lovastatin90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0762-0EA - Each50090-0762e726a733-d061-4262-a74a-0d62283d295012018-10-11
50090-0762-2EA - Each50090-07623b78bd8a-19d3-431f-81ea-36c28f3f154f12018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0762LOVASTATIN TABLET LOVASTATIN TABLET [A-S MEDICATION SOLUTIONS]18Current NDC, Legacy NDC, 2 package rows20241016_02aae38d-ee9d-4c09-a155-b69f221ed3e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletPSN02aae38d-ee9d-4c09-a155-b69f221ed3e918
197904lovastatin 20 MG Oral TabletSCD02aae38d-ee9d-4c09-a155-b69f221ed3e918
197905lovastatin 40 MG Oral TabletSCD02aae38d-ee9d-4c09-a155-b69f221ed3e918

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0762-05009007620030 TABLET in 1 BOTTLE (50090-0762-0) 30 tablet2014-11-280000-00-00NoNoCurrent
50090-0762-25009007620290 TABLET in 1 BOTTLE (50090-0762-2) 90 tablet2014-11-280000-00-00NoNoCurrent