NDC 65841-065

Simvastatin

Simvastatin

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

Product ID65841-065_138ca8f8-701c-4a2d-b6e7-0f077eb30d77
NDC65841-065
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2006-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA077837
Labeler NameCadila Healthcare Limited
Substance NameSIMVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 65841-065-05

500 TABLET, FILM COATED in 1 BOTTLE (65841-065-05)
Marketing Start Date2006-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65841-065-14 [65841006514]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65841-065-16 [65841006516]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65841-065-10 [65841006510]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65841-065-05 [65841006505]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

NDC 65841-065-06 [65841006506]

Simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077837
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2006-12-20

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN5 mg/1

OpenFDA Data

SPL SET ID:881eb80b-712e-4aa2-bd23-290a3e5db6cd
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.