NDC 53217-304

Lovastatin

Lovastatin

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

Product ID53217-304_c7fd107c-3617-431e-be92-01c5e88a5662
NDC53217-304
Product TypeHuman Prescription Drug
Proprietary NameLovastatin
Generic NameLovastatin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2007-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA078296
Labeler NameAidarex Pharmaceuticals LLC
Substance NameLOVASTATIN
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-304-02

120 TABLET in 1 BOTTLE (53217-304-02)
Marketing Start Date2007-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-304-30 [53217030430]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-11-01
Inactivation Date2020-01-31

NDC 53217-304-90 [53217030490]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-11-01
Inactivation Date2020-01-31

NDC 53217-304-02 [53217030402]

Lovastatin TABLET
Marketing CategoryANDA
Application NumberANDA078296
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-11-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LOVASTATIN10 mg/1

OpenFDA Data

SPL SET ID:f208f4a4-cb3f-40bd-9873-bba0c8ae8bd4
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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.