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
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

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

Identifiers & Regulatory

Product NDC 23155-834
Product ID 23155-834_a5f5d785-6a2e-41e1-8114-92ce7ca5d8fe
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040858
Listing Expiration 2026-12-31
Marketing Start 2023-08-02

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 23155834
Hyphenated Format 23155-834

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0323155833010 0323155832013 0323155834017
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 ANDA040858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (23155-834-01)
  • 1000 TABLET in 1 BOTTLE (23155-834-10)
source: ndc

Packages (2)

23155-834-01 100 TABLET in 1 BOTTLE (23155-834-01) 23155-834-10 1000 TABLET in 1 BOTTLE (23155-834-10)

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": "a5f5d785-6a2e-41e1-8114-92ce7ca5d8fe", "openfda": {"upc": ["0323155833010", "0323155832013", "0323155834017"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["669532c9-ba15-4f4b-95a8-13782deb3521"], "manufacturer_name": ["Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (23155-834-01)", "package_ndc": "23155-834-01", "marketing_start_date": "20230802"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (23155-834-10)", "package_ndc": "23155-834-10", "marketing_start_date": "20230802"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "23155-834_a5f5d785-6a2e-41e1-8114-92ce7ca5d8fe", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "23155-834", "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": "ANDA040858", "marketing_category": "ANDA", "marketing_start_date": "20230802", "listing_expiration_date": "20261231"}