hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler baxter healthcare corporation
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 43066-041
Product ID 43066-041_f1a10203-f027-4f9c-8dd6-907c6db24d47
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219797
Listing Expiration 2026-12-31
Marketing Start 2025-07-17

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43066041
Hyphenated Format 43066-041

Supplemental Identifiers

RxCUI
966571
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 ANDA219797 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (43066-041-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43066-041-01)
source: ndc

Packages (1)

43066-041-25 25 VIAL, SINGLE-DOSE in 1 CARTON (43066-041-25) / 1 mL in 1 VIAL, SINGLE-DOSE (43066-041-01)

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": "f1a10203-f027-4f9c-8dd6-907c6db24d47", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["f1a10203-f027-4f9c-8dd6-907c6db24d47"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (43066-041-25)  / 1 mL in 1 VIAL, SINGLE-DOSE (43066-041-01)", "package_ndc": "43066-041-25", "marketing_start_date": "20250717"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "43066-041_f1a10203-f027-4f9c-8dd6-907c6db24d47", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "43066-041", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA219797", "marketing_category": "ANDA", "marketing_start_date": "20250717", "listing_expiration_date": "20261231"}