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] |