Hydralazine Hydrochloride
- Product NDC
- 55154-0187
- 11-digit product format
- 551540187
- Labeler code
- 55154
- Product ID
- 55154-0187_6d2e05d1-0c58-4aea-9f93-e67ea66e31e1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040858
- Marketing category
- ANDA
- Marketing start
- 2025-07-09
- 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
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 | 50 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 905225, 905395 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-0187-0 | Hydralazine Hydrochloride | 10 in 1 BAG | TABLET | 10 | | 3 |
| 55154-0187-0 | Hydralazine Hydrochloride | 1 in 1 BLISTER PACK | TABLET | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-0187-0 | 55154018700 | 10 BLISTER PACK in 1 BAG (55154-0187-0) / 1 TABLET in 1 BLISTER PACK | 10 blister pack | 2025-07-09 | No | No | Historical |