hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-5085
Product ID 55154-5085_a165dff2-f60a-4183-afe3-3adc336763a9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088468
Listing Expiration 2026-12-31
Marketing Start 2011-05-13

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551545085
Hyphenated Format 55154-5085

Supplemental Identifiers

RxCUI
905225 905395
UPC
0055154508506 0055154568906
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 ANDA088468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-5085-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

Ingredients (1)

hydralazine hydrochloride (50 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "a165dff2-f60a-4183-afe3-3adc336763a9", "openfda": {"upc": ["0055154508506", "0055154568906"], "unii": ["FD171B778Y"], "rxcui": ["905225", "905395"], "spl_set_id": ["db7500f3-f8a6-46b1-bb64-9727617a9643"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-5085-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-5085-0", "marketing_start_date": "20110513"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "55154-5085_a165dff2-f60a-4183-afe3-3adc336763a9", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "55154-5085", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA088468", "marketing_category": "ANDA", "marketing_start_date": "20110513", "listing_expiration_date": "20261231"}