isosorbide dinitrate and hydralazine hydrochloride
- Product NDC
- 72162-2343
- 11-digit product format
- 721622343
- Labeler code
- 72162
- Product ID
- 72162-2343_09016810-23d1-4df1-831d-cc346dee1b52
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride and isosorbide dinitrate
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- NDA020727
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2022-04-15
- Substance
- HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
- Active strength
- 37.5; 20 mg/1; mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC], Nitrate Vasodilator [EPC], Nitrates [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| FD171B778Y | HYDRALAZINE HYDROCHLORIDE | 304-20-1 | HYDRALAZINE HYDROCHLORIDE |
| IA7306519N | ISOSORBIDE DINITRATE | 87-33-2 | ISOSORBIDE DINITRATE |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-2343-9 | 72162234309 | 90 TABLET, FILM COATED in 1 BOTTLE (72162-2343-9) | 2024-07-01 | No | No | Historical |