Lovastatin

Product NDC
68071-4955
11-digit product format
680714955
Labeler code
68071
Product ID
68071-4955_1b2e475a-4c92-6395-e063-6394a90ad5a7
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
10 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
LOVASTATIN10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197903

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4955-3Lovastatin30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4955LOVASTATIN TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240619_8ccb2a86-cd02-4162-e053-2995a90abe0e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN8ccb2a86-cd02-4162-e053-2995a90abe0e3
197903lovastatin 10 MG Oral TabletSCD8ccb2a86-cd02-4162-e053-2995a90abe0e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4955-36807149550330 TABLET in 1 BOTTLE (68071-4955-3) 30 tablet2019-07-030000-00-00NoNoCurrent