NDC 70377-001

Simvastatin

Simvastatin

Simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Biocon Pharma Inc,. The primary component is Simvastatin.

Product ID70377-001_4ea81ae0-c11c-fb4b-7d9a-99bcc5e17dfe
NDC70377-001
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-17
Marketing CategoryANDA / ANDA
Application NumberANDA078034
Labeler NameBiocon Pharma Inc,
Substance NameSIMVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70377-001-12

30 TABLET, FILM COATED in 1 BOTTLE (70377-001-12)
Marketing Start Date2015-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70377-001-15 [70377000115]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-17

NDC 70377-001-12 [70377000112]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-17

NDC 70377-001-13 [70377000113]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-17

NDC 70377-001-14 [70377000114]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-12-17

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN5 mg/1

OpenFDA Data

SPL SET ID:7b325108-6940-50a7-96b4-822a5206e568
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312962
  • 312961
    • UPC Code
  • 0370377001123
  • 0370377005121
  • 0370377004124
  • 0370377003127
  • 0370377002120

    • Pharmacological Class

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

    Medicade Reported Pricing

    70377000115 SIMVASTATIN 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    70377000114 SIMVASTATIN 5 MG TABLET

    Pricing Unit: EA | Drug Type:

    70377000112 SIMVASTATIN 5 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
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