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
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 100 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-5424
Product ID 63629-5424_1bccffd8-62f7-4dc3-8bb9-c47287c718a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040901
Listing Expiration 2026-12-31
Marketing Start 2010-01-01

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636295424
Hyphenated Format 63629-5424

Supplemental Identifiers

RxCUI
905222
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 ANDA040901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (63629-5424-1)
  • 60 TABLET in 1 BOTTLE (63629-5424-2)
  • 90 TABLET in 1 BOTTLE (63629-5424-3)
  • 100 TABLET in 1 BOTTLE (63629-5424-4)
source: ndc

Packages (4)

63629-5424-1 30 TABLET in 1 BOTTLE (63629-5424-1) 63629-5424-2 60 TABLET in 1 BOTTLE (63629-5424-2) 63629-5424-3 90 TABLET in 1 BOTTLE (63629-5424-3) 63629-5424-4 100 TABLET in 1 BOTTLE (63629-5424-4)

Ingredients (1)

hydralazine hydrochloride (100 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": "1bccffd8-62f7-4dc3-8bb9-c47287c718a3", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905222"], "spl_set_id": ["d79eb016-30c0-4d3f-b854-ada5a43fe5f7"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (63629-5424-1)", "package_ndc": "63629-5424-1", "marketing_start_date": "20140910"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (63629-5424-2)", "package_ndc": "63629-5424-2", "marketing_start_date": "20151210"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (63629-5424-3)", "package_ndc": "63629-5424-3", "marketing_start_date": "20171120"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (63629-5424-4)", "package_ndc": "63629-5424-4", "marketing_start_date": "20240402"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "63629-5424_1bccffd8-62f7-4dc3-8bb9-c47287c718a3", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "63629-5424", "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": "100 mg/1"}], "application_number": "ANDA040901", "marketing_category": "ANDA", "marketing_start_date": "20100101", "listing_expiration_date": "20261231"}