| Product NDC: | 68012-003 |
| Proprietary Name: | Glumetza |
| Non Proprietary Name: | metformin hydrochloride |
| Active Ingredient(s): | 1000 mg/1 & nbsp; metformin hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 68012-003 |
| Labeler Name: | Santarus, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021748 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20080617 |
| Package NDC: | 68012-003-16 |
| Package Description: | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16) |
| NDC Code | 68012-003-16 |
| Proprietary Name | Glumetza |
| Package Description | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68012-003-16) |
| Product NDC | 68012-003 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | metformin hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20080617 |
| Marketing Category Name | NDA |
| Labeler Name | Santarus, Inc. |
| Substance Name | METFORMIN HYDROCHLORIDE |
| Strength Number | 1000 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Biguanide [EPC],Biguanides [Chemical/Ingredient] |