HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 55150-400
- 11-digit product format
- 551500400
- Labeler code
- 55150
- Product ID
- 55150-400_f725ae73-cab2-4a30-901c-9f8856803f3a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDRALAZINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA215147
- Marketing category
- ANDA
- Marketing start
- 2023-02-13
- 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 |
|---|
| 55150-400-25 | HYDRALAZINE HYDROCHLORIDE | 25 in 1 CARTON | INJECTION | 25 | | 4 |
| 55150-400-25 | HYDRALAZINE HYDROCHLORIDE | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55150-400 | HYDRALAZINE HYDROCHLORIDE INJECTION [EUGIA US LLC] | 3 | Current NDC, 2 package rows | 20240316_e08d8b6c-a184-4dd5-84ef-bac90e4b1c33.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55150-400-25 | 55150040025 | 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 1 mL in 1 VIAL, SINGLE-DOSE | 2023-02-13 | No | No | Current |