hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-400
Product ID 55150-400_f725ae73-cab2-4a30-901c-9f8856803f3a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215147
Listing Expiration 2026-12-31
Marketing Start 2023-02-13

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150400
Hyphenated Format 55150-400

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 ANDA215147 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55150-400-25 25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25) / 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": "f725ae73-cab2-4a30-901c-9f8856803f3a", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["e08d8b6c-a184-4dd5-84ef-bac90e4b1c33"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 CARTON (55150-400-25)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55150-400-25", "marketing_start_date": "20230213"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "55150-400_f725ae73-cab2-4a30-901c-9f8856803f3a", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "55150-400", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "20 mg/mL"}], "application_number": "ANDA215147", "marketing_category": "ANDA", "marketing_start_date": "20230213", "listing_expiration_date": "20261231"}