Hydralazine Hydrochloride
- Product NDC
- 71335-1589
- 11-digit product format
- 713351589
- Labeler code
- 71335
- Product ID
- 71335-1589_15abfa42-46a4-441c-aca2-25377e0719db
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 100 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905222, 905225 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1589-1 | Hydralazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 71335-1589-2 | Hydralazine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 71335-1589-3 | Hydralazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1589 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 6 | Current NDC, Legacy NDC, 3 package rows | 20250331_d2d98842-ff32-4a61-94e0-60e06919948f.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71335-1589-1 | 71335158901 | 30 TABLET in 1 BOTTLE (71335-1589-1) | 30 tablet | 2014-09-12 | 0000-00-00 | No | No | Current |
| 71335-1589-2 | 71335158902 | 60 TABLET in 1 BOTTLE (71335-1589-2) | 60 tablet | 2014-09-12 | 0000-00-00 | No | No | Current |
| 71335-1589-3 | 71335158903 | 90 TABLET in 1 BOTTLE (71335-1589-3) | 90 tablet | 2014-09-12 | 0000-00-00 | No | No | Current |