NDC 82009-016

Simvastatin

Simvastatin

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

Product ID82009-016_e0c15105-6390-33af-e053-2a95a90a46f8
NDC82009-016
Product TypeHuman Prescription Drug
Proprietary NameSimvastatin
Generic NameSimvastatin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-05-26
Marketing CategoryANDA /
Application NumberANDA200895
Labeler NameQuallent Pharmaceuticals Health LLC
Substance NameSIMVASTATIN
Active Ingredient Strength5 mg/1
Pharm ClassesHMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 82009-016-90

90 TABLET, FILM COATED in 1 BOTTLE (82009-016-90)
Marketing Start Date2022-05-26
NDC Exclude FlagN
Sample Package?N

Drug Details

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.