NDC 42658-109

Simvastatin

Simvastatin

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

Product ID42658-109_5e149e75-fdbe-a512-e053-2a91aa0a1b6b
NDC42658-109
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-13
Marketing CategoryANDA / ANDA
Application NumberANDA206557
Labeler NameHisun Pharmaceuticals USA, Inc.
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 42658-109-01

30 TABLET, FILM COATED in 1 BOTTLE (42658-109-01)
Marketing Start Date2020-05-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42658-109-01 [42658010901]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206557
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

NDC 42658-109-04 [42658010904]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206557
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

NDC 42658-109-08 [42658010908]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206557
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-01

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/1

OpenFDA Data

SPL SET ID:6a365728-e31a-428f-9718-d1a34d686186
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231
  • 200345
  • 198211
  • 312961
    • UPC Code
  • 0342658108081
  • 0342658111081
  • 0342658110084
  • 0342658109088

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