hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 23155-003
Product ID 23155-003_e092716d-6522-4cfb-8728-622f9b553ef1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Marketing Start 2007-04-06
Marketing End 2026-09-30

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155003
Hyphenated Format 23155-003

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0323155003017 0323155004014 0323155002010
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 ANDA086242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)
source: ndc

Packages (2)

23155-003-01 100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01) 23155-003-10 1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)

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": "e092716d-6522-4cfb-8728-622f9b553ef1", "openfda": {"upc": ["0323155003017", "0323155004014", "0323155002010"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["a04eefaf-ba3c-448d-8ece-4aa9ab2e3508"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (23155-003-01)", "package_ndc": "23155-003-01", "marketing_end_date": "20260930", "marketing_start_date": "20070406"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (23155-003-10)", "package_ndc": "23155-003-10", "marketing_end_date": "20260930", "marketing_start_date": "20070406"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "23155-003_e092716d-6522-4cfb-8728-622f9b553ef1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "23155-003", "generic_name": "hydralazine hydrochloride", "labeler_name": "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA086242", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20070406"}