Hydralazine Hydrochloride
- Product NDC
- 71335-1685
- 11-digit product format
- 713351685
- Labeler code
- 71335
- Product ID
- 71335-1685_65e187b7-1f5e-438c-839d-5ea7cc947545
- 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
- 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 table| Ingredient | Strength |
|---|
| HYDRALAZINE HYDROCHLORIDE | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905199 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71335-1685-1 | Hydralazine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 8 |
| 71335-1685-2 | Hydralazine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 8 |
| 71335-1685-3 | Hydralazine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 8 |
| 71335-1685-4 | Hydralazine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-1685 | HYDRALAZINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 8 | Current NDC, Legacy NDC, 4 package rows | 20250402_a79ddc89-546b-4808-879d-c0f592141636.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 |
|---|
| 71335-1685-1 | 71335168501 | 30 TABLET in 1 BOTTLE (71335-1685-1) | 30 tablet | 2020-08-06 | 0000-00-00 | No | No | Current |
| 71335-1685-2 | 71335168502 | 60 TABLET in 1 BOTTLE (71335-1685-2) | 60 tablet | 2020-08-06 | 0000-00-00 | No | No | Current |
| 71335-1685-3 | 71335168503 | 90 TABLET in 1 BOTTLE (71335-1685-3) | 90 tablet | 2020-08-06 | 0000-00-00 | No | No | Current |
| 71335-1685-4 | 71335168504 | 100 TABLET in 1 BOTTLE (71335-1685-4) | 100 tablet | 2020-08-06 | | No | No | Historical |