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
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 100 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 82804-197
Product ID 82804-197_775e99c4-e18d-4648-a0e3-8709950249ff
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040901
Listing Expiration 2026-12-31
Marketing Start 2010-01-01

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82804197
Hyphenated Format 82804-197

Supplemental Identifiers

RxCUI
905222
UPC
0382804197309
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 ANDA040901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (82804-197-30)
source: ndc

Packages (1)

82804-197-30 30 TABLET in 1 BOTTLE (82804-197-30)

Ingredients (1)

hydralazine hydrochloride (100 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": "775e99c4-e18d-4648-a0e3-8709950249ff", "openfda": {"upc": ["0382804197309"], "unii": ["FD171B778Y"], "rxcui": ["905222"], "spl_set_id": ["775e99c4-e18d-4648-a0e3-8709950249ff"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (82804-197-30)", "package_ndc": "82804-197-30", "marketing_start_date": "20250219"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "82804-197_775e99c4-e18d-4648-a0e3-8709950249ff", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "82804-197", "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": "100 mg/1"}], "application_number": "ANDA040901", "marketing_category": "ANDA", "marketing_start_date": "20100101", "listing_expiration_date": "20261231"}