isosorbide dinitrate and hydralazine hydrochloride is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Wilshire Pharmaceuticals. The primary component is Hydralazine Hydrochloride; Isosorbide Dinitrate.
| Product ID | 52536-006_13386839-9eb4-4956-a788-d94a7b63cb77 |
| NDC | 52536-006 |
| Product Type | Human Prescription Drug |
| Proprietary Name | isosorbide dinitrate and hydralazine hydrochloride |
| Generic Name | Hydralazine Hydrochloride And Isosorbide Dinitrate |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-04-15 |
| Marketing Category | NDA AUTHORIZED GENERIC / |
| Application Number | NDA020727 |
| Labeler Name | Wilshire Pharmaceuticals |
| Substance Name | HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE |
| Active Ingredient Strength | 38 mg/1; mg/1 |
| Pharm Classes | Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |