NDC Code | 52536-006-09 |
Package Description | 90 TABLET, FILM COATED in 1 BOTTLE (52536-006-09) |
Product NDC | 52536-006 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Proprietary Name | Isosorbide Dinitrate And Hydralazine Hydrochloride |
Non-Proprietary Name | Hydralazine Hydrochloride And Isosorbide Dinitrate |
Dosage Form | TABLET, FILM COATED |
Usage | ORAL |
Start Marketing Date | 20220415 |
Marketing Category Name | NDA AUTHORIZED GENERIC |
Application Number | NDA020727 |
Manufacturer | Wilshire Pharmaceuticals |
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 [CS], Vasodilation [PE] |