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 INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

hydralazine hydrochloride 20 mg/mL

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-9554
Product ID 55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040388
Listing Expiration 2026-12-31
Marketing Start 2001-09-05

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551549554
Hyphenated Format 55154-9554

Supplemental Identifiers

RxCUI
966571
UPC
0055154955454
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 ANDA040388 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 20 mg/mL
source: ndc
Packaging
  • 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5) / 1 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

55154-9554-5 5 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5) / 1 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

hydralazine hydrochloride (20 mg/mL)

Linked Drug Pages (1)

Hydralazine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "858b3d0d-fbaf-47dc-ab92-3afe2877fdd1", "openfda": {"upc": ["0055154955454"], "unii": ["FD171B778Y"], "rxcui": ["966571"], "spl_set_id": ["43ce0ecb-6d62-44bf-8539-823ae03eb9f4"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 VIAL, SINGLE-DOSE in 1 BAG (55154-9554-5)  / 1 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55154-9554-5", "marketing_start_date": "20010905"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "55154-9554_858b3d0d-fbaf-47dc-ab92-3afe2877fdd1", "dosage_form": "INJECTION", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "55154-9554", "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": "20 mg/mL"}], "application_number": "ANDA040388", "marketing_category": "ANDA", "marketing_start_date": "20010905", "listing_expiration_date": "20261231"}