hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5696
Product ID 63629-5696_989ad2d9-0548-4cf8-8fdf-99e18bbb24e6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Listing Expiration 2026-12-31
Marketing Start 2007-04-06

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636295696
Hyphenated Format 63629-5696

Supplemental Identifiers

RxCUI
905225
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 ANDA086242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (63629-5696-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63629-5696-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63629-5696-3)
  • 10 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4)
source: ndc

Packages (4)

63629-5696-1 30 TABLET, FILM COATED in 1 BOTTLE (63629-5696-1) 63629-5696-2 60 TABLET, FILM COATED in 1 BOTTLE (63629-5696-2) 63629-5696-3 90 TABLET, FILM COATED in 1 BOTTLE (63629-5696-3) 63629-5696-4 10 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4)

Ingredients (1)

hydralazine hydrochloride (25 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": "989ad2d9-0548-4cf8-8fdf-99e18bbb24e6", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905225"], "spl_set_id": ["db138daf-2d2d-4730-a621-a1bd209d5b9f"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63629-5696-1)", "package_ndc": "63629-5696-1", "marketing_start_date": "20170629"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63629-5696-2)", "package_ndc": "63629-5696-2", "marketing_start_date": "20160624"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63629-5696-3)", "package_ndc": "63629-5696-3", "marketing_start_date": "20150715"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63629-5696-4)", "package_ndc": "63629-5696-4", "marketing_start_date": "20240402"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "63629-5696_989ad2d9-0548-4cf8-8fdf-99e18bbb24e6", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "63629-5696", "generic_name": "hydralazine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA086242", "marketing_category": "ANDA", "marketing_start_date": "20070406", "listing_expiration_date": "20261231"}