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
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-045
Product ID 82868-045_46dcba1e-2a2e-cfd1-e063-6394a90a19ee
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040858
Listing Expiration 2026-12-31
Marketing Start 2024-02-15

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868045
Hyphenated Format 82868-045

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 ANDA040858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE, PLASTIC (82868-045-30)
source: ndc

Packages (1)

82868-045-30 30 TABLET in 1 BOTTLE, PLASTIC (82868-045-30)

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": "46dcba1e-2a2e-cfd1-e063-6394a90a19ee", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905225"], "spl_set_id": ["1275dd50-d97f-2e8f-e063-6394a90a4a67"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (82868-045-30)", "package_ndc": "82868-045-30", "marketing_start_date": "20240215"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "82868-045_46dcba1e-2a2e-cfd1-e063-6394a90a19ee", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "82868-045", "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": "25 mg/1"}], "application_number": "ANDA040858", "marketing_category": "ANDA", "marketing_start_date": "20240215", "listing_expiration_date": "20261231"}