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 55154-2140
Product ID 55154-2140_a1092c5e-4a8b-4d87-bec6-9523a38f0e2a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040858
Listing Expiration 2026-12-31
Marketing Start 2024-11-22

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551542140
Hyphenated Format 55154-2140

Supplemental Identifiers

RxCUI
905225 905395
UPC
0055154214100 0055154214001
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 ANDA040858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-2140-0) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (1)

55154-2140-0 10 BLISTER PACK in 1 BAG (55154-2140-0) / 1 TABLET in 1 BLISTER PACK

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": "a1092c5e-4a8b-4d87-bec6-9523a38f0e2a", "openfda": {"upc": ["0055154214100", "0055154214001"], "unii": ["FD171B778Y"], "rxcui": ["905225", "905395"], "spl_set_id": ["a1066707-2391-4918-8ded-600c017fde48"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-2140-0)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "55154-2140-0", "marketing_start_date": "20241122"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "55154-2140_a1092c5e-4a8b-4d87-bec6-9523a38f0e2a", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "55154-2140", "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": "ANDA040858", "marketing_category": "ANDA", "marketing_start_date": "20241122", "listing_expiration_date": "20261231"}