NDC 13107-051

Simvastatin

Simvastatin

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

Product ID13107-051_8a37015f-aa57-4a43-9ff0-2ca5540f357d
NDC13107-051
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2009-11-09
Marketing CategoryANDA / ANDA
Application NumberANDA077691
Labeler NameAurolife Pharma LLC
Substance NameSIMVASTATIN
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 13107-051-00

100 TABLET, FILM COATED in 1 BOTTLE (13107-051-00)
Marketing Start Date2009-11-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13107-051-99 [13107005199]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 13107-051-90 [13107005190]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 13107-051-00 [13107005100]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 13107-051-30 [13107005130]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 13107-051-01 [13107005101]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

NDC 13107-051-26 [13107005126]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077691
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2009-11-09
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN10 mg/1

OpenFDA Data

SPL SET ID:a9415031-0643-42f6-a162-662433fc1071
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312962
  • 312961
    • UPC Code
  • 0313107054990
  • 0313107052262
  • 0313107053221
  • 0313107051265
  • 0313107050268

    • 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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