NDC 63629-3393

simvastatin

Simvastatin

simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Simvastatin.

Product ID63629-3393_297fd3b8-9562-4aa1-ae0c-e33b5cc79881
NDC63629-3393
Product TypeHuman Prescription Drug
Proprietary Namesimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA078155
Labeler NameBryant Ranch Prepack
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-3393-1

30 TABLET, FILM COATED in 1 BOTTLE (63629-3393-1)
Marketing Start Date2008-02-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-3393-5 [63629339305]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-2 [63629339302]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-4 [63629339304]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-7 [63629339307]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-1 [63629339301]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-3 [63629339303]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

NDC 63629-3393-6 [63629339306]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-30
Marketing End Date2018-06-30

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/1

OpenFDA Data

SPL SET ID:79ca09cd-2396-4e50-b159-1f9567115067
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312961
  • Pharmacological Class

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

    NDC Crossover Matching brand name "simvastatin" or generic name "Simvastatin"

    NDCBrand NameGeneric Name
    0093-7152SimvastatinSimvastatin
    0093-7153SimvastatinSimvastatin
    0093-7154SimvastatinSimvastatin
    0093-7155SimvastatinSimvastatin
    0093-7156SimvastatinSimvastatin
    0179-0128SimvastatinSimvastatin
    0179-0240simvastatinsimvastatin
    0179-0241simvastatinsimvastatin
    0179-0242simvastatinsimvastatin
    0179-0243simvastatinsimvastatin
    0179-1897SimvastatinSimvastatin
    0179-1898SimvastatinSimvastatin
    0179-1899SimvastatinSimvastatin
    0615-6579SimvastatinSimvastatin
    0615-6580SimvastatinSimvastatin
    0615-6581SimvastatinSimvastatin
    0615-6587SimvastatinSimvastatin
    0615-6588SimvastatinSimvastatin
    0615-7704SimvastatinSimvastatin
    0615-7705SimvastatinSimvastatin
    0615-7706SimvastatinSimvastatin
    68071-1646simvastatinsimvastatin
    68071-1965simvastatinsimvastatin
    68071-1721simvastatinsimvastatin
    68071-1711simvastatinsimvastatin
    68071-2092SimvastatinSimvastatin
    68071-1990simvastatinsimvastatin
    68071-1699simvastatinsimvastatin
    68071-1868simvastatinsimvastatin
    68071-1946simvastatinsimvastatin
    68071-3115SimvastatinSimvastatin
    68071-3391simvastatinsimvastatin
    68071-3157SimvastatinSimvastatin
    68071-3289simvastatinsimvastatin
    68071-4331SIMVASTATINSIMVASTATIN
    68071-4504simvastatinsimvastatin
    68084-512SimvastatinSimvastatin
    68151-0177SimvastatinSimvastatin
    68084-511SimvastatinSimvastatin
    68180-481SIMVASTATINSIMVASTATIN
    68180-482SIMVASTATINSIMVASTATIN
    68180-465SIMVASTATINSIMVASTATIN
    68180-478SIMVASTATINSIMVASTATIN
    68180-480SIMVASTATINSIMVASTATIN
    68180-464SIMVASTATINSIMVASTATIN
    68180-479SIMVASTATINSIMVASTATIN
    68382-069SimvastatinSimvastatin
    68382-067SimvastatinSimvastatin
    68382-065SimvastatinSimvastatin
    68382-068SimvastatinSimvastatin

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