FDA.reportPublic FDA data

Lovastatin

Product NDC
50090-3881
11-digit product format
500903881
Labeler code
50090
Product ID
50090-3881_0488aa52-5670-4d63-b19d-c87064af839d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA075991
Marketing category
ANDA
Marketing start
2002-11-25
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
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
LOVASTATIN20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904

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
50090-3881-02023-02-07C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP
50090-3881-02023-02-07C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision M
50090-3881-22023-02-07C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP
50090-3881-22023-02-07C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision M
50090-3881-02023-01-30C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP
50090-3881-02023-01-30C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision M
50090-3881-22023-01-30C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP
50090-3881-22023-01-30C16284748780-1f386c649-e97e-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3881-0Lovastatin30 in 1 BOTTLETABLET309
50090-3881-2Lovastatin90 in 1 BOTTLE, PLASTICTABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3881-0EA - Each50090-3881a5fec284-8960-4006-8b9e-4d27939f86f412021-12-08
50090-3881-2EA - Each50090-38812f6a927d-e5a9-4e5a-af3f-db7f9813ebed12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3881LOVASTATIN TABLET [A-S MEDICATION SOLUTIONS]7Current NDC, Legacy NDC, 2 package rows20230208_dd7a223e-7fc5-4eb0-9bd7-2f9a2d6b4173.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNdd7a223e-7fc5-4eb0-9bd7-2f9a2d6b41739
197904lovastatin 20 MG Oral TabletSCDdd7a223e-7fc5-4eb0-9bd7-2f9a2d6b41739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3881-05009038810030 TABLET in 1 BOTTLE (50090-3881-0) 30 tablet2018-11-280000-00-00NoNoCurrent
50090-3881-25009038810290 TABLET in 1 BOTTLE, PLASTIC (50090-3881-2) 90 tablet2014-11-280000-00-00NoNoCurrent