| NDC Code | 0378-6001-91 |
|---|
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-6001-91) |
|---|
| Product NDC | 0378-6001 |
|---|
| Product Type Name | HUMAN PRESCRIPTION DRUG |
|---|
| Proprietary Name | Metformin Hydrochloride |
|---|
| Non-Proprietary Name | Metformin |
|---|
| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
|---|
| Usage | ORAL |
|---|
| Start Marketing Date | 20160823 |
|---|
| Marketing Category Name | ANDA |
|---|
| Application Number | ANDA200690 |
|---|
| Manufacturer | Mylan Pharmaceuticals Inc. |
|---|
| Substance Name | METFORMIN HYDROCHLORIDE |
|---|
| Strength | 1000 |
|---|
| Strength Unit | mg/1 |
|---|
| Pharmacy Classes | Biguanide [EPC], Biguanides [CS] |
|---|