Hydralazine Hydrochloride
- Product NDC
- 33342-375
- 11-digit product format
- 333420375
- Labeler code
- 33342
- Product ID
- 33342-375_f9f56326-6d72-47d3-89ac-3625b8a6d713
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Macleods Pharmaceuticals Limited
- Application
- ANDA211010
- Marketing category
- ANDA
- Marketing start
- 2024-08-26
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 25 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 |
|---|
| 33342-375-11 | 33342037511 | 100 TABLET in 1 BOTTLE (33342-375-11) | 100 tablet | 2024-08-26 | No | No | Historical |
| 33342-375-12 | 33342037512 | 10 BLISTER PACK in 1 CARTON (33342-375-12) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2024-08-26 | No | No | Historical |
| 33342-375-44 | 33342037544 | 1000 TABLET in 1 BOTTLE (33342-375-44) | 1000 tablet | 2024-08-26 | No | No | Historical |