Hydralazine Hydrochloride
- Product NDC
- 0404-9787
- 11-digit product format
- 004049787
- Labeler code
- 0404
- Product ID
- 0404-9787_e1a12f59-87d5-4b78-8405-e0c6a3e4369e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDRALAZINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Henry Schein, Inc.
- Application
- ANDA040388
- Marketing category
- ANDA
- Marketing start
- 2025-04-10
- 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 |
|---|
| 0404-9787-01 | Hydralazine Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 2 |
| 0404-9787-01 | Hydralazine Hydrochloride | 1 in 1 BAG | INJECTION | 1 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0404-9787 | HYDRALAZINE HYDROCHLORIDE INJECTION [HENRY SCHEIN, INC.] | 2 | Current NDC, 2 package rows | 20250522_4d1f55aa-e924-4540-ae9f-bd7362a82f33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0404-9787-01 | 00404978701 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-04-10 | No | No | Historical |