hydrALAZINE Hydrochloride
- Product NDC
- 84549-614
- 11-digit product format
- 845490614
- Labeler code
- 84549
- Product ID
- 84549-614_3a38e0e3-de87-9cb7-e063-6294a90a60ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrALAZINE Hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- ProPharma Distribution
- Application
- ANDA040388
- Marketing category
- ANDA
- Marketing start
- 2011-01-31
- 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 |
|---|
| 84549-614-55 | hydrALAZINE Hydrochloride | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 1 | | 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 |
|---|
| 84549-614-55 | 84549061455 | 1 mL in 1 VIAL, SINGLE-DOSE (84549-614-55) | 1 ml | 2025-08-27 | No | No | Historical |