hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler henry schein, inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9787
Product ID 0404-9787_e1a12f59-87d5-4b78-8405-e0c6a3e4369e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040388
Listing Expiration 2026-12-31
Marketing Start 2025-04-10

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049787
Hyphenated Format 0404-9787

Supplemental Identifiers

RxCUI
966571
UNII
FD171B778Y

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 ANDA040388 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9787-01 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01) / 1 mL in 1 VIAL, SINGLE-DOSE

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": "e1a12f59-87d5-4b78-8405-e0c6a3e4369e", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["4d1f55aa-e924-4540-ae9f-bd7362a82f33"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9787-01)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9787-01", "marketing_start_date": "20250410"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "0404-9787_e1a12f59-87d5-4b78-8405-e0c6a3e4369e", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "0404-9787", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA040388", "marketing_category": "ANDA", "marketing_start_date": "20250410", "listing_expiration_date": "20261231"}