Hydralazine Hydrochloride
- Product NDC
- 55154-9587
- 11-digit product format
- 551549587
- Labeler code
- 55154
- Product ID
- 55154-9587_b7c211a9-fd05-46ae-87e8-10475663d9bc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDRALAZINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Cardinal Health 107, LLC
- Application
- ANDA040388
- Marketing category
- ANDA
- Marketing start
- 2024-10-31
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- 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 | 20 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FD171B778Y |
| Rxcui | 966571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55154-9587-5 | Hydralazine Hydrochloride | 1 mL in 1 VIAL, SINGLE-USE | INJECTION | 1 | | 2 |
| 55154-9587-5 | Hydralazine Hydrochloride | 5 in 1 BAG | INJECTION | 5 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55154-9587 | HYDRALAZINE HYDROCHLORIDE INJECTION [CARDINAL HEALTH 107, LLC] | 1 | Current NDC, 2 package rows | 20241103_8b7e88ef-5edd-40df-8e43-e3f29970be58.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55154-9587-5 | 55154958705 | 5 VIAL, SINGLE-USE in 1 BAG (55154-9587-5) / 1 mL in 1 VIAL, SINGLE-USE | 2024-10-31 | No | No | Current |