NDC 63629-8130

simvastatin

Simvastatin

simvastatin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Simvastatin.

Product ID63629-8130_200b008e-dc78-48d7-a658-46a077ee329c
NDC63629-8130
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 NameBryant Ranch Prepack
Substance NameSIMVASTATIN
Active Ingredient Strength20 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63629-8130-1

90 TABLET, FILM COATED in 1 BOTTLE (63629-8130-1)
Marketing Start Date2019-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63629-8130-2 [63629813002]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-29

NDC 63629-8130-1 [63629813001]

simvastatin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078155
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-29

Drug Details

Active Ingredients

IngredientStrength
SIMVASTATIN20 mg/1

OpenFDA Data

SPL SET ID:356ed6a6-e467-4791-87ff-2ae7779fc1b0
Manufacturer
UNII

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
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