Hydralazine Hydrochloride
- Product NDC
- 82804-197
- 11-digit product format
- 828040197
- Labeler code
- 82804
- Product ID
- 82804-197_775e99c4-e18d-4648-a0e3-8709950249ff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA040901
- Marketing category
- ANDA
- Marketing start
- 2010-01-01
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 100 mg/1
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- 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 |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 82804-197-30 | 82804019730 | 30 TABLET in 1 BOTTLE (82804-197-30) | 30 tablet | 2025-02-19 | No | No | Historical |