| NDC Code | 52125-740-23 |
| Package Description | 180 TABLET, FILM COATED in 1 BOTTLE (52125-740-23) |
| Product NDC | 52125-740 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Proprietary Name | Bidil |
| Non-Proprietary Name | Hydralazine Hydrochloride And Isosorbide Dinitrate |
| Dosage Form | TABLET, FILM COATED |
| Usage | ORAL |
| Start Marketing Date | 20131008 |
| Marketing Category Name | NDA |
| Application Number | NDA020727 |
| Manufacturer | REMEDYREPACK INC. |
| Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
| Strength | 37.5; 20 |
| Strength Unit | mg/1; mg/1 |
| Pharmacy Classes | Arteriolar Vasodilation [PE],Arteriolar Vasodilator [EPC],Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |