FDA.reportPublic FDA data

Lovastatin

Product NDC
71335-0045
11-digit product format
713350045
Labeler code
71335
Product ID
71335-0045_4735ddec-8682-48be-bf8d-6916c5443848
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0045-1Lovastatin30 in 1 BOTTLETABLET308
71335-0045-2Lovastatin60 in 1 BOTTLETABLET608
71335-0045-3Lovastatin90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0045-1EA - Each71335-004574c67a06-8077-45f8-92b2-b76602cfd02612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0045LOVASTATIN TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 3 package rows20240822_5684ceb8-a5b2-4fb4-92be-14aabcea3871.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197905lovastatin 40 MG Oral TabletPSN5684ceb8-a5b2-4fb4-92be-14aabcea38718
197905lovastatin 40 MG Oral TabletSCD5684ceb8-a5b2-4fb4-92be-14aabcea38718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0045-17133500450130 TABLET in 1 BOTTLE (71335-0045-1) 30 tablet2018-06-190000-00-00NoNoCurrent
71335-0045-27133500450260 TABLET in 1 BOTTLE (71335-0045-2) 60 tablet2018-04-270000-00-00NoNoCurrent
71335-0045-37133500450390 TABLET in 1 BOTTLE (71335-0045-3) 90 tablet2018-06-040000-00-00NoNoCurrent