FDA.reportPublic FDA data

Lovastatin

Product NDC
66267-561
11-digit product format
662670561
Labeler code
66267
Product ID
66267-561_1fa711ca-cee6-fae5-e063-6294a90aa5d0
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
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
Rxcui197905

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
66267-561-302024-08-14C16284748780-1f386c649-eec1-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision I
66267-561-902024-08-14C16284748780-1f386c649-eec1-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision I
66267-561-302023-01-30C16284748780-1f386c649-eec1-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision I
66267-561-902023-01-30C16284748780-1f386c649-eec1-0266-e053-dadaa90a7c1aLovastatin Tablet USP Revision I

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66267-561-30Lovastatin30 in 1 BOTTLETABLET305
66267-561-90Lovastatin90 in 1 BOTTLETABLET905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66267-561LOVASTATIN TABLET [NUCARE PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 2 package rows20240815_4444573e-9df1-01e6-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSN4444573e-9df1-01e6-e054-00144ff8d46c5
197905lovastatin 40 MG Oral TabletSCD4444573e-9df1-01e6-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66267-561-306626705613030 TABLET in 1 BOTTLE (66267-561-30) 30 tablet2016-12-220000-00-00NoNoCurrent
66267-561-906626705619090 TABLET in 1 BOTTLE (66267-561-90) 90 tablet2016-12-220000-00-00NoNoCurrent