NDC 55111-199

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is Simvastatin.

Product ID55111-199_84334c5d-1663-972c-5d96-03eb1be16f64
NDC55111-199
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA077752
Labeler NameDr. Reddy's Laboratories Limited
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55111-199-01

100 TABLET, FILM COATED in 1 BOTTLE (55111-199-01)
Marketing Start Date2006-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55111-199-01 [55111019901]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 55111-199-30 [55111019930]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 55111-199-10 [55111019910]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 55111-199-78 [55111019978]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 55111-199-05 [55111019905]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

NDC 55111-199-60 [55111019960]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 55111-199-90 [55111019990]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-12-20

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/1

OpenFDA Data

SPL SET ID:d9a1a7c5-d806-4dbd-a201-5e73790d078b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312962
  • 312961
  • Pharmacological Class

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

    Medicade Reported Pricing

    55111019990 SIMVASTATIN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    55111019930 SIMVASTATIN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    55111019910 SIMVASTATIN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    55111019905 SIMVASTATIN 20 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

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