Lovastatin

Product NDC
63187-194
11-digit product format
631870194
Labeler code
63187
Product ID
63187-194_ca1866cb-6cfc-40f3-8bf7-9b2d7ef1219a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-194-30Lovastatin30 in 1 BOTTLETABLET304
63187-194-60Lovastatin60 in 1 BOTTLETABLET604
63187-194-90Lovastatin90 in 1 BOTTLETABLET904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOVASTATINACTIVE INGREDIENT9LHU78OQFDLOVASTATIN TABLET [PROFICIENT RX LP]1
LOVASTATINACTIVE MOIETY9LHU78OQFDLOVASTATIN TABLET [PROFICIENT RX LP]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2ULOVASTATIN TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULOVASTATIN TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [PROFICIENT RX LP]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGLOVASTATIN TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOVASTATIN TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [PROFICIENT RX LP]1
TALCINACTIVE INGREDIENT7SEV7J4R1ULOVASTATIN TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-194LOVASTATIN TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20210121_c2b1b926-def3-4411-9aed-395b969028fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197903lovastatin 10 MG Oral TabletPSNc2b1b926-def3-4411-9aed-395b969028fe4
197903lovastatin 10 MG Oral TabletSCDc2b1b926-def3-4411-9aed-395b969028fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-194-306318701943030 TABLET in 1 BOTTLE (63187-194-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-194-606318701946060 TABLET in 1 BOTTLE (63187-194-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-194-906318701949090 TABLET in 1 BOTTLE (63187-194-90) 90 tablet2015-02-020000-00-00NoNoCurrent