Hydralazine Hydrochloride
- Product NDC
- 68475-514
- 11-digit product format
- 684750514
- Labeler code
- 68475
- Product ID
- 68475-514_e9ca27ef-fa6d-4b88-a84b-9a56bffe2020
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Hydralazine Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Navinta LLC
- Application
- ANDA202938
- Marketing category
- ANDA
- Marketing start
- 2025-11-25
- Substance
- HYDRALAZINE HYDROCHLORIDE
- Active strength
- 20 mg/mL
- Pharmacologic classes
- Arteriolar Vasodilation [PE], Arteriolar Vasodilator [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Hydralazine Hydrochloride
- Listing expiration
- 2027-12-31
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 |
|---|
| 68475-514-01 | Hydralazine Hydrochloride | 1 mL in 1 VIAL | INJECTION | 1 | | 2 |
| 68475-514-02 | Hydralazine Hydrochloride | 25 in 1 PACKAGE | INJECTION | 25 | | 2 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 68475-514-01 | 68475051401 | 1 mL in 1 VIAL | 1 ml | | | | Historical |
| 68475-514-02 | 68475051402 | 25 VIAL in 1 PACKAGE (68475-514-02) / 1 mL in 1 VIAL (68475-514-01) | 25 vial | 2025-11-25 | No | No | Historical |