HYDRALAZINE HYDROCHLORIDE
- Product NDC
- 51662-1388
- 11-digit product format
- 516621388
- Labeler code
- 51662
- Product ID
- 51662-1388_2b377557-c2e1-ba26-e063-6394a90a64ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- HYDRALAZINE HYDROCHLORIDE
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- ANDA040730
- Marketing category
- ANDA
- Marketing start
- 2019-10-07
- 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 |
|---|
| 51662-1388-1 | 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 |
|---|
| 51662-1388 | HYDRALAZINE HYDROCHLORIDE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250110_94530e4d-b1c0-6171-e053-2a95a90a05fa.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1388-1 | 51662138801 | 1 mL in 1 VIAL, SINGLE-DOSE (51662-1388-1) | 1 ml | 2019-10-07 | 0000-00-00 | No | No | Current |