Hydralazine Hydrochloride
- Product NDC
- 67046-1609
- 11-digit product format
- 670461609
- Labeler code
- 67046
- Product ID
- 67046-1609_41c023cd-3a20-a16a-e063-6294a90a493e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA205236
- Marketing category
- ANDA
- Marketing start
- 2025-10-22
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 10 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 |
|---|
| 67046-1609-3 | 67046160903 | 30 TABLET in 1 BLISTER PACK (67046-1609-3) | 30 tablet | 2025-10-22 | No | No | Historical |