Lovastatin

Product NDC
50090-3396
11-digit product format
500903396
Labeler code
50090
Product ID
50090-3396_17a6f508-050d-4663-a459-221a7346e2aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078296
Marketing category
ANDA
Marketing start
2008-03-14
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
50090-3396-0Lovastatin30 in 1 BOTTLETABLET3010
50090-3396-1Lovastatin90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3396-1EA - Each50090-3396a6cdf80a-b9b1-41e8-97d6-d7a8cef2b56212019-05-02

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSN06b8c398-ce2e-42c1-b1a8-73cc59a080db10
197903lovastatin 10 MG Oral TabletSCD06b8c398-ce2e-42c1-b1a8-73cc59a080db10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3396-05009033960030 TABLET in 1 BOTTLE (50090-3396-0) 30 tablet2019-10-090000-00-00NoNoCurrent
50090-3396-15009033960190 TABLET in 1 BOTTLE (50090-3396-1) 90 tablet2018-03-120000-00-00NoNoCurrent