NDC 65727-065

Simvastatin

Simvastatin

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

Product ID65727-065_3ff17740-c7a8-095b-f5fc-78e73ab285f6
NDC65727-065
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 Limited
Substance NameSIMVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 65727-065-13

45 TABLET, FILM COATED in 1 BOTTLE (65727-065-13)
Marketing Start Date2015-12-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65727-065-14 [65727006514]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-17
Inactivation Date2020-01-31

NDC 65727-065-13 [65727006513]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-17
Inactivation Date2020-01-31

NDC 65727-065-12 [65727006512]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-17
Inactivation Date2020-01-31

NDC 65727-065-15 [65727006515]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078034
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-17
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN5 mg/1

OpenFDA Data

SPL SET ID:7ad38e3b-79a8-f4c1-0662-c24f3e897ac7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312962
  • 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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