hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: exelan pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler exelan pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-311
Product ID 76282-311_f313fc00-1f7a-40ea-9d61-29c4bfba2426
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090255
Listing Expiration 2026-12-31
Marketing Start 2016-05-20

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282311
Hyphenated Format 76282-311

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0376282309019 0376282310015 0376282311012 0376282312019
UNII
FD171B778Y

Packaging Origin

Original Packager
true

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 ANDA090255 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76282-311-01)
  • 1000 TABLET in 1 BOTTLE (76282-311-10)
source: ndc

Packages (2)

76282-311-01 100 TABLET in 1 BOTTLE (76282-311-01) 76282-311-10 1000 TABLET in 1 BOTTLE (76282-311-10)

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": "f313fc00-1f7a-40ea-9d61-29c4bfba2426", "openfda": {"upc": ["0376282309019", "0376282310015", "0376282311012", "0376282312019"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["811831f9-a844-463a-874d-fb8407659f0b"], "manufacturer_name": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76282-311-01)", "package_ndc": "76282-311-01", "marketing_start_date": "20160520"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (76282-311-10)", "package_ndc": "76282-311-10", "marketing_start_date": "20160520"}], "brand_name": "HydrALAZINE Hydrochloride", "product_id": "76282-311_f313fc00-1f7a-40ea-9d61-29c4bfba2426", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "76282-311", "generic_name": "HydrALAZINE Hydrochloride", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HydrALAZINE Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA090255", "marketing_category": "ANDA", "marketing_start_date": "20160520", "listing_expiration_date": "20261231"}