NDC 57297-464

SIMVASTATIN

Simvastatin

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

Product ID57297-464_c4be39fe-ec4b-4d8c-b540-9311111dac1c
NDC57297-464
Product TypeHuman Prescription Drug
Proprietary NameSIMVASTATIN
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2015-12-02
Marketing CategoryANDA / ANDA
Application NumberANDA078103
Labeler NameLUPIN LIMITED
Substance NameSIMVASTATIN
Active Ingredient Strength40 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 57297-464-06

30 TABLET, FILM COATED in 1 BOTTLE (57297-464-06)
Marketing Start Date2015-12-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 57297-464-09 [57297046409]

SIMVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078103
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-02
Inactivation Date2020-01-31

NDC 57297-464-03 [57297046403]

SIMVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078103
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-02
Inactivation Date2020-01-31

NDC 57297-464-06 [57297046406]

SIMVASTATIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078103
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-12-02
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN40 mg/1

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.