hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7449
Product ID 0904-7449_73a8ca83-9f63-4264-b36f-e133d98d5002
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040858
Listing Expiration 2026-12-31
Marketing Start 2025-01-03

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047449
Hyphenated Format 0904-7449

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
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 ANDA040858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7449-61) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7449-61 100 BLISTER PACK in 1 CARTON (0904-7449-61) / 1 TABLET in 1 BLISTER PACK

Ingredients (1)

hydralazine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "73a8ca83-9f63-4264-b36f-e133d98d5002", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["b6ccd35e-f69c-4eef-a456-905e030ae911"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7449-61)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-7449-61", "marketing_start_date": "20250103"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "0904-7449_73a8ca83-9f63-4264-b36f-e133d98d5002", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "0904-7449", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040858", "marketing_category": "ANDA", "marketing_start_date": "20250103", "listing_expiration_date": "20261231"}