| Product NDC: | 16729-005 |
| Proprietary Name: | simvastatin |
| Non Proprietary Name: | simvastatin |
| Active Ingredient(s): | 20 mg/1 & nbsp; simvastatin |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16729-005 |
| Labeler Name: | Accord Healthcare, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA078155 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20080226 |
| Package NDC: | 16729-005-12 |
| Package Description: | 60 TABLET, FILM COATED in 1 BOTTLE (16729-005-12) |
| NDC Code | 16729-005-12 |
| Proprietary Name | simvastatin |
| Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (16729-005-12) |
| Product NDC | 16729-005 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | simvastatin |
| Dosage Form Name | TABLET, FILM COATED |
| Route Name | ORAL |
| Start Marketing Date | 20080226 |
| Marketing Category Name | ANDA |
| Labeler Name | Accord Healthcare, Inc. |
| Substance Name | SIMVASTATIN |
| Strength Number | 20 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA] |