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Simvastatin - 13107-053-22 - (Simvastatin)

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Drug Information of Simvastatin

Product NDC: 13107-053
Proprietary Name: Simvastatin
Non Proprietary Name: Simvastatin
Active Ingredient(s): 40    mg/1 & nbsp;   Simvastatin
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Simvastatin

Product NDC: 13107-053
Labeler Name: Aurolife Pharma LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA077691
Marketing Category: ANDA
Start Marketing Date: 20091109

Package Information of Simvastatin

Package NDC: 13107-053-22
Package Description: 2000 TABLET, FILM COATED in 1 BOTTLE (13107-053-22)

NDC Information of Simvastatin

NDC Code 13107-053-22
Proprietary Name Simvastatin
Package Description 2000 TABLET, FILM COATED in 1 BOTTLE (13107-053-22)
Product NDC 13107-053
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Simvastatin
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20091109
Marketing Category Name ANDA
Labeler Name Aurolife Pharma LLC
Substance Name SIMVASTATIN
Strength Number 40
Strength Unit mg/1
Pharmaceutical Classes HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]

Complete Information of Simvastatin


General Information