| Product NDC: | 0904-5795 |
| Proprietary Name: | Metformin Hydrochloride Extended Release |
| Non Proprietary Name: | metformin hydrochloride |
| Active Ingredient(s): | 750 mg/1 & nbsp; metformin hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0904-5795 |
| Labeler Name: | Major Pharmaceuticals |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076706 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20090610 |
| Package NDC: | 0904-5795-61 |
| Package Description: | 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0904-5795-61) |
| NDC Code | 0904-5795-61 |
| Proprietary Name | Metformin Hydrochloride Extended Release |
| Package Description | 100 TABLET, EXTENDED RELEASE in 1 BOX, UNIT-DOSE (0904-5795-61) |
| Product NDC | 0904-5795 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | metformin hydrochloride |
| Dosage Form Name | TABLET, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20090610 |
| Marketing Category Name | ANDA |
| Labeler Name | Major Pharmaceuticals |
| Substance Name | METFORMIN HYDROCHLORIDE |
| Strength Number | 750 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Biguanide [EPC],Biguanides [Chemical/Ingredient] |