hydralazine hydrochloride

Generic: hydralazine hydrochloride

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

Drug Facts

Product Profile

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

hydralazine hydrochloride 25 mg/1

Manufacturer
ScieGen Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 50228-183
Product ID 50228-183_bcb83203-049e-1ddd-e053-2a95a90ae336
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205236
Listing Expiration 2026-12-31
Marketing Start 2017-05-26

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50228183
Hyphenated Format 50228-183

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0350228182010 0350228182102 0350228183017 0350228184014 0350228183109 0350228185103 0350228184106 0350228185011
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 ANDA205236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (50228-183-01)
  • 1000 TABLET in 1 BOTTLE (50228-183-10)
source: ndc

Packages (2)

50228-183-01 100 TABLET in 1 BOTTLE (50228-183-01) 50228-183-10 1000 TABLET in 1 BOTTLE (50228-183-10)

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": "bcb83203-049e-1ddd-e053-2a95a90ae336", "openfda": {"upc": ["0350228182010", "0350228182102", "0350228183017", "0350228184014", "0350228183109", "0350228185103", "0350228184106", "0350228185011"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["500b7f76-5f4e-4e7d-85c3-18b9f66d7504"], "manufacturer_name": ["ScieGen Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (50228-183-01)", "package_ndc": "50228-183-01", "marketing_start_date": "20170526"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (50228-183-10)", "package_ndc": "50228-183-10", "marketing_start_date": "20170526"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "50228-183_bcb83203-049e-1ddd-e053-2a95a90ae336", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "50228-183", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "ScieGen Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA205236", "marketing_category": "ANDA", "marketing_start_date": "20170526", "listing_expiration_date": "20261231"}