Hydralazine Hydrochloride
- Product NDC
- 63629-8493
- 11-digit product format
- 636298493
- Labeler code
- 63629
- Product ID
- 63629-8493_6cbee232-1810-4489-b081-362d0e41399b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA205236
- Marketing category
- ANDA
- Marketing start
- 2017-05-26
- 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
Additional Listing Data
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients
| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers
| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199 |
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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-8493-1 | 63629849301 | 1000 TABLET in 1 BOTTLE (63629-8493-1) | 1000 tablet | 2021-05-18 | 0000-00-00 | No | No | Current |