hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: zydus pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler zydus pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 70710-1988
Product ID 70710-1988_35a2dca2-f3f1-4718-85b7-79597d6e7f43
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202938
Listing Expiration 2026-12-31
Marketing Start 2025-04-28

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707101988
Hyphenated Format 70710-1988

Supplemental Identifiers

RxCUI
966571
UPC
0370710198817
UNII
FD171B778Y

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydralazine hydrochloride (source: ndc)
Generic Name hydralazine hydrochloride (source: ndc)
Application Number ANDA202938 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 PACKAGE (70710-1988-7) / 1 mL in 1 VIAL (70710-1988-1)
source: ndc

Packages (1)

70710-1988-7 25 VIAL in 1 PACKAGE (70710-1988-7) / 1 mL in 1 VIAL (70710-1988-1)

Ingredients (1)

hydralazine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "35a2dca2-f3f1-4718-85b7-79597d6e7f43", "openfda": {"upc": ["0370710198817"], "unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["f0db9c3c-d841-46f9-8409-9ffca83d7a97"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 PACKAGE (70710-1988-7)  / 1 mL in 1 VIAL (70710-1988-1)", "package_ndc": "70710-1988-7", "marketing_start_date": "20250428"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "70710-1988_35a2dca2-f3f1-4718-85b7-79597d6e7f43", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "70710-1988", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA202938", "marketing_category": "ANDA", "marketing_start_date": "20250428", "listing_expiration_date": "20261231"}