FDA.reportPublic FDA data

Lovastatin

Product NDC
68071-3127
11-digit product format
680713127
Labeler code
68071
Product ID
68071-3127_1d9eba8e-7610-37b9-e063-6394a90aa528
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
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
68071-3127-32021-02-11C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I
68071-3127-62021-02-11C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I
68071-3127-92021-02-11C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I
68071-3127-32021-01-29C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I
68071-3127-62021-01-29C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I
68071-3127-92021-01-29C16284748780-1ba0f9c33-4de4-a910-e053-dadaa90a0b85Lovastatin Tablet USP Revision I

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3127-3Lovastatin30 in 1 BOTTLETABLET306
68071-3127-6Lovastatin60 in 1 BOTTLETABLET606
68071-3127-9Lovastatin90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3127LOVASTATIN TABLET [NUCARE PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 3 package rows20240720_4aa44b69-2946-2fb1-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSN4aa44b69-2946-2fb1-e054-00144ff8d46c6
197904lovastatin 20 MG Oral TabletSCD4aa44b69-2946-2fb1-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-3127-36807131270330 TABLET in 1 BOTTLE (68071-3127-3) 30 tablet2017-03-130000-00-00NoNoCurrent
68071-3127-66807131270660 TABLET in 1 BOTTLE (68071-3127-6) 60 tablet2017-03-130000-00-00NoNoCurrent
68071-3127-96807131270990 TABLET in 1 BOTTLE (68071-3127-9) 90 tablet2017-03-130000-00-00NoNoCurrent