hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-916
Product ID 51655-916_4974183f-5839-7ea9-e063-6294a90ad99e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA086242
Marketing Start 2020-05-26
Marketing End 2026-08-31

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655916
Hyphenated Format 51655-916

Supplemental Identifiers

RxCUI
905395
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
  • 50 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-26)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-52)
source: ndc

Packages (2)

51655-916-26 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-26) 51655-916-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-52)

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": "4974183f-5839-7ea9-e063-6294a90ad99e", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905395"], "spl_set_id": ["ada28f78-e933-7acf-e053-2995a90ae316"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-26)", "package_ndc": "51655-916-26", "marketing_end_date": "20260831", "marketing_start_date": "20200526"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-916-52)", "package_ndc": "51655-916-52", "marketing_end_date": "20260831", "marketing_start_date": "20230712"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "51655-916_4974183f-5839-7ea9-e063-6294a90ad99e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "51655-916", "generic_name": "hydralazine hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA086242", "marketing_category": "ANDA", "marketing_end_date": "20260831", "marketing_start_date": "20200526"}