Product NDC: | 68180-482 |
Proprietary Name: | Simvastatin |
Non Proprietary Name: | Simvastatin |
Active Ingredient(s): | 5 mg/1 & nbsp; Simvastatin |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68180-482 |
Labeler Name: | Lupin Pharmaceuticals, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078103 |
Marketing Category: | ANDA |
Start Marketing Date: | 20090701 |
Package NDC: | 68180-482-13 |
Package Description: | 6 BLISTER PACK in 1 CARTON (68180-482-13) > 10 TABLET in 1 BLISTER PACK (68180-482-11) |
NDC Code | 68180-482-13 |
Proprietary Name | Simvastatin |
Package Description | 6 BLISTER PACK in 1 CARTON (68180-482-13) > 10 TABLET in 1 BLISTER PACK (68180-482-11) |
Product NDC | 68180-482 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Simvastatin |
Dosage Form Name | TABLET |
Route Name | ORAL |
Start Marketing Date | 20090701 |
Marketing Category Name | ANDA |
Labeler Name | Lupin Pharmaceuticals, Inc. |
Substance Name | SIMVASTATIN |
Strength Number | 5 |
Strength Unit | mg/1 |
Pharmaceutical Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |