hydralazine

Generic: hydralazine hydrochloride

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

Drug Facts

Product Profile

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

hydralazine hydrochloride 100 mg/1

Manufacturer
Nivagen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 75834-128
Product ID 75834-128_379fe677-a8e7-4bfe-abcf-85283768c27b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203845
Listing Expiration 2026-12-31
Marketing Start 2017-02-15

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 75834128
Hyphenated Format 75834-128

Supplemental Identifiers

RxCUI
905222 905225 905395
UPC
0375834127019 0375834126012 0375834128016
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 (source: ndc)
Generic Name hydralazine hydrochloride (source: ndc)
Application Number ANDA203845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (75834-128-00)
  • 100 TABLET in 1 BOTTLE (75834-128-01)
source: ndc

Packages (2)

75834-128-00 1000 TABLET in 1 BOTTLE (75834-128-00) 75834-128-01 100 TABLET in 1 BOTTLE (75834-128-01)

Ingredients (1)

hydralazine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Hydralazine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "379fe677-a8e7-4bfe-abcf-85283768c27b", "openfda": {"upc": ["0375834127019", "0375834126012", "0375834128016"], "unii": ["FD171B778Y"], "rxcui": ["905222", "905225", "905395"], "spl_set_id": ["1fd8cf42-66ae-4af5-a5ae-7c9679a0e532"], "manufacturer_name": ["Nivagen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (75834-128-00)", "package_ndc": "75834-128-00", "marketing_start_date": "20170215"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (75834-128-01)", "package_ndc": "75834-128-01", "marketing_start_date": "20170215"}], "brand_name": "Hydralazine", "product_id": "75834-128_379fe677-a8e7-4bfe-abcf-85283768c27b", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "75834-128", "generic_name": "HYDRALAZINE HYDROCHLORIDE", "labeler_name": "Nivagen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA203845", "marketing_category": "ANDA", "marketing_start_date": "20170215", "listing_expiration_date": "20261231"}