FDA.reportPublic FDA data

Lovastatin

Product NDC
68071-3261
11-digit product format
680713261
Labeler code
68071
Product ID
68071-3261_2d540607-1803-4063-e063-6294a90a7159
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA078296
Marketing category
ANDA
Marketing start
2007-11-01
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
68071-3261-32025-02-04C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-62025-02-04C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-92025-02-04C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-32025-01-30C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-62025-01-30C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only
68071-3261-92025-01-30C16284748780-12cef2736-5d70-d83d-e063-dadaa90ab31fLOVASTATIN TABLETS USP 10 mg, 20 mg and 40 mg Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3261-3Lovastatin30 in 1 BOTTLETABLET306
68071-3261-6Lovastatin60 in 1 BOTTLETABLET606
68071-3261-9Lovastatin90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3261LOVASTATIN TABLET [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20250206_50217921-97a7-6ff2-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN50217921-97a7-6ff2-e054-00144ff88e886
197904lovastatin 20 MG Oral TabletSCD50217921-97a7-6ff2-e054-00144ff88e886

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3261-36807132610330 TABLET in 1 BOTTLE (68071-3261-3) 30 tablet2017-05-220000-00-00NoNoCurrent
68071-3261-66807132610660 TABLET in 1 BOTTLE (68071-3261-6) 60 tablet2017-05-220000-00-00NoNoCurrent
68071-3261-96807132610990 TABLET in 1 BOTTLE (68071-3261-9) 90 tablet2017-05-220000-00-00NoNoCurrent