FDA.reportPublic FDA data

Lovastatin

Product NDC
68788-9668
11-digit product format
687889668
Labeler code
68788
Product ID
68788-9668_23083ca2-f964-462d-ad8a-3def5fef86bb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lovastatin
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA075991
Marketing category
ANDA
Marketing start
2013-07-29
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOVASTATIN40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9LHU78OQFD
Rxcui197904, 197905

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
68788-9668-1Lovastatin100 in 1 BOTTLETABLET10011
68788-9668-3Lovastatin30 in 1 BOTTLETABLET3011
68788-9668-6Lovastatin60 in 1 BOTTLETABLET6011
68788-9668-9Lovastatin90 in 1 BOTTLETABLET9011

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
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJLOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2
TALCINACTIVE INGREDIENT7SEV7J4R1ULOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9668LOVASTATIN TABLET [PREFERRED PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 4 package rows20240117_ea4df37b-21e9-4dc3-83af-1be1b50bfdc9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197904lovastatin 20 MG Oral TabletPSNea4df37b-21e9-4dc3-83af-1be1b50bfdc911
197905lovastatin 40 MG Oral TabletPSNea4df37b-21e9-4dc3-83af-1be1b50bfdc911
197904lovastatin 20 MG Oral TabletSCDea4df37b-21e9-4dc3-83af-1be1b50bfdc911
197905lovastatin 40 MG Oral TabletSCDea4df37b-21e9-4dc3-83af-1be1b50bfdc911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9668-168788966801100 TABLET in 1 BOTTLE (68788-9668-1) 100 tablet2013-07-290000-00-00NoNoCurrent
68788-9668-36878896680330 TABLET in 1 BOTTLE (68788-9668-3) 30 tablet2013-07-290000-00-00NoNoCurrent
68788-9668-66878896680660 TABLET in 1 BOTTLE (68788-9668-6) 60 tablet2013-07-290000-00-00NoNoCurrent
68788-9668-96878896680990 TABLET in 1 BOTTLE (68788-9668-9) 90 tablet2013-07-290000-00-00NoNoCurrent