HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 67046-1517
- 11-digit product format
- 670461517
- Labeler code
- 67046
- Product ID
- 67046-1517_2df48c89-03d8-aa07-e063-6394a90acb7e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydralazine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Coupler LLC
- Application
- ANDA203845
- Marketing category
- ANDA
- Marketing start
- 2025-02-12
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 50 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 |
|---|
| 67046-1517-3 | 67046151703 | 30 TABLET in 1 BLISTER PACK (67046-1517-3) | 30 tablet | 2025-02-12 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rx only | Coupler LLC | 2025-02-12 | HUMAN PRESCRIPTION DRUG LABEL | 1 |