hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 55289-133
Product ID 55289-133_47e36800-0665-cf64-e063-6294a90a85af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Listing Expiration 2027-12-31
Marketing Start 2007-04-06

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55289133
Hyphenated Format 55289-133

Supplemental Identifiers

RxCUI
905225
UPC
0355289133605
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 ANDA086242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-133-60)
source: ndc

Packages (1)

55289-133-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-133-60)

Ingredients (1)

hydralazine hydrochloride (25 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": "47e36800-0665-cf64-e063-6294a90a85af", "openfda": {"upc": ["0355289133605"], "unii": ["FD171B778Y"], "rxcui": ["905225"], "spl_set_id": ["4671cefa-4468-4116-ba40-3d3b0f581ea1"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55289-133-60)", "package_ndc": "55289-133-60", "marketing_start_date": "20220624"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "55289-133_47e36800-0665-cf64-e063-6294a90a85af", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "55289-133", "generic_name": "hydralazine hydrochloride", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA086242", "marketing_category": "ANDA", "marketing_start_date": "20070406", "listing_expiration_date": "20271231"}