hydralazine hydrochloride

Generic: hydralazine hydrochloride

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

Drug Facts

Product Profile

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

hydralazine hydrochloride 25 mg/1

Manufacturer
Radha Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 77771-183
Product ID 77771-183_bd5f421e-db2b-6f83-e053-2a95a90ab05e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205236
Listing Expiration 2026-12-31
Marketing Start 2021-03-04

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 77771183
Hyphenated Format 77771-183

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0377771182014 0377771182106 0377771183011 0377771185015 0377771183103 0377771184018 0377771184100
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 (77771-183-01)
  • 1000 TABLET in 1 BOTTLE (77771-183-10)
source: ndc

Packages (2)

77771-183-01 100 TABLET in 1 BOTTLE (77771-183-01) 77771-183-10 1000 TABLET in 1 BOTTLE (77771-183-10)

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": "bd5f421e-db2b-6f83-e053-2a95a90ab05e", "openfda": {"upc": ["0377771182014", "0377771182106", "0377771183011", "0377771185015", "0377771183103", "0377771184018", "0377771184100"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["149fa857-30ad-451d-b6e2-0000483ccc97"], "manufacturer_name": ["Radha Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (77771-183-01)", "package_ndc": "77771-183-01", "marketing_start_date": "20210304"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (77771-183-10)", "package_ndc": "77771-183-10", "marketing_start_date": "20210304"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "77771-183_bd5f421e-db2b-6f83-e053-2a95a90ab05e", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "77771-183", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Radha 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": "20210304", "listing_expiration_date": "20261231"}