hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler proficient rx lp
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-901
Product ID 63187-901_8abc5903-cbd2-436d-b229-4e76d3726e09
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Listing Expiration 2026-12-31
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 63187901
Hyphenated Format 63187-901

Supplemental Identifiers

RxCUI
905225
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
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-901-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-901-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-901-90)
source: ndc

Packages (3)

63187-901-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-901-30) 63187-901-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-901-60) 63187-901-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-901-90)

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": "8abc5903-cbd2-436d-b229-4e76d3726e09", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905225"], "spl_set_id": ["63f388e0-9f3d-4902-990c-9a105aa098ad"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-901-30)", "package_ndc": "63187-901-30", "marketing_start_date": "20170901"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-901-60)", "package_ndc": "63187-901-60", "marketing_start_date": "20170901"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-901-90)", "package_ndc": "63187-901-90", "marketing_start_date": "20170901"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "63187-901_8abc5903-cbd2-436d-b229-4e76d3726e09", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "63187-901", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Proficient Rx LP", "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": "20261231"}