NDC 53002-1385

Lovastatin

Lovastatin

Lovastatin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rpk Pharmaceuticals, Inc.. The primary component is Lovastatin.

Product ID53002-1385_5c6704b8-e965-449b-bdf9-c7cada185cf0
NDC53002-1385
Product TypeHuman Prescription Drug
Proprietary NameLovastatin
Generic NameLovastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA078296
Labeler NameRPK Pharmaceuticals, Inc.
Substance NameLOVASTATIN
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53002-1385-0

100 TABLET in 1 BOTTLE (53002-1385-0)
Marketing Start Date2017-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53002-1385-6 [53002138506]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1385-0 [53002138500]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

NDC 53002-1385-3 [53002138503]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LOVASTATIN10 mg/1

OpenFDA Data

SPL SET ID:0d3d6373-e3e9-456b-99eb-fbfe86a9ac32
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197903

    • Pharmacological Class

    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

    NDC Crossover Matching brand name "Lovastatin" or generic name "Lovastatin"

    NDCBrand NameGeneric Name
    0093-0576LovastatinLovastatin
    0093-0926LovastatinLovastatin
    0093-0928LovastatinLovastatin
    0185-0070LovastatinLovastatin
    0185-0072LovastatinLovastatin
    0185-0074LovastatinLovastatin
    0440-6694LovastatinLovastatin
    0615-5589LovastatinLovastatin
    0615-6551LovastatinLovastatin
    0615-6590LovastatinLovastatin
    0615-7674LovastatinLovastatin
    0615-7679LovastatinLovastatin
    0615-7685LovastatinLovastatin
    0615-7690LovastatinLovastatin
    0615-8151Lovastatinlovastatin
    0615-8152Lovastatinlovastatin
    10544-235LovastatinLovastatin
    10544-241LovastatinLovastatin
    10544-242LovastatinLovastatin
    10544-246LovastatinLovastatin
    21695-534LovastatinLovastatin
    21695-535LovastatinLovastatin
    21695-536LovastatinLovastatin
    33261-547LovastatinLovastatin
    33261-548LovastatinLovastatin
    33261-549LovastatinLovastatin
    35356-885LovastatinLovastatin
    42254-025LovastatinLovastatin
    42254-028LovastatinLovastatin
    42254-106LovastatinLovastatin
    68001-224LovastatinLovastatin
    68001-315LovastatinLovastatin
    68001-316LovastatinLovastatin
    68001-214LovastatinLovastatin
    68001-314LovastatinLovastatin
    68071-3108LovastatinLovastatin
    68071-1973LovastatinLovastatin
    68071-3127LovastatinLovastatin
    68071-3261LovastatinLovastatin
    68071-3397LovastatinLovastatin
    68071-4271LovastatinLovastatin
    68084-559LovastatinLovastatin
    68180-468LovastatinLovastatin
    68180-467LovastatinLovastatin
    68180-469LovastatinLovastatin
    68645-576LovastatinLovastatin
    68645-566LovastatinLovastatin
    68788-2634LovastatinLovastatin
    68645-567LovastatinLovastatin
    68788-0926LovastatinLovastatin
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