NDC 71610-250

simvastatin

Simvastatin

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

Product ID71610-250_e41229de-e579-41f7-bfc0-a9fcef4abe0d
NDC71610-250
Product TypeHuman Prescription Drug
Proprietary Namesimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-02-26
Marketing CategoryANDA / ANDA
Application NumberANDA078155
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameSIMVASTATIN
Active Ingredient Strength10 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71610-250-30

30 TABLET, FILM COATED in 1 BOTTLE (71610-250-30)
Marketing Start Date2019-03-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-250-30 [71610025030]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-14

NDC 71610-250-60 [71610025060]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-14

NDC 71610-250-45 [71610025045]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-03-14

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN10 mg/1

OpenFDA Data

SPL SET ID:121b0e00-abb7-4e07-a7b2-311be89fabb7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 314231

    • Pharmacological Class

    • HMG-CoA Reductase Inhibitor [EPC]
    • Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
    • 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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.