Lovastatin

Product NDC
68788-9181
11-digit product format
687889181
Labeler code
68788
Product ID
68788-9181_84e34b24-b38d-4c7a-ac35-1542df41185b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc
Application
ANDA075828
Marketing category
ANDA
Marketing start
2005-10-27
Marketing end
0000-00-00
Substance
LOVASTATIN
Active strength
20 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
68788-9181-1Lovastatin100 in 1 BOTTLE, DISPENSINGTABLET1003
68788-9181-3Lovastatin30 in 1 BOTTLE, DISPENSINGTABLET303
68788-9181-6Lovastatin60 in 1 BOTTLE, DISPENSINGTABLET603
68788-9181-9Lovastatin90 in 1 BOTTLE, DISPENSINGTABLET903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9181LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC]3Legacy NDC, 4 package rows20161230_f5766e3f-374d-47b5-b141-2767cb7a4693.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNf5766e3f-374d-47b5-b141-2767cb7a46933
197904lovastatin 20 MG Oral TabletSCDf5766e3f-374d-47b5-b141-2767cb7a46933

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-9181-168788918101100 in 1 BOTTLE, DISPENSINGHistorical
68788-9181-36878891810330 in 1 BOTTLE, DISPENSINGHistorical
68788-9181-66878891810660 in 1 BOTTLE, DISPENSINGHistorical
68788-9181-96878891810990 in 1 BOTTLE, DISPENSINGHistorical