hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: cadila pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler cadila pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Cadila Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 71209-016
Product ID 71209-016_4cdbf75c-b17f-4c40-bd7c-7b07668e9659
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203845
Listing Expiration 2026-12-31
Marketing Start 2015-12-29

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71209016
Hyphenated Format 71209-016

Supplemental Identifiers

RxCUI
905222 905225 905395
UPC
0371209018050
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 ANDA203845 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (71209-016-05)
  • 1000 TABLET in 1 BOTTLE (71209-016-11)
source: ndc

Packages (2)

71209-016-05 100 TABLET in 1 BOTTLE (71209-016-05) 71209-016-11 1000 TABLET in 1 BOTTLE (71209-016-11)

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": "4cdbf75c-b17f-4c40-bd7c-7b07668e9659", "openfda": {"upc": ["0371209018050"], "unii": ["FD171B778Y"], "rxcui": ["905222", "905225", "905395"], "spl_set_id": ["3a7562a8-2f67-4411-ac4a-ab7924193e82"], "manufacturer_name": ["Cadila Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (71209-016-05)", "package_ndc": "71209-016-05", "marketing_start_date": "20151229"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (71209-016-11)", "package_ndc": "71209-016-11", "marketing_start_date": "20151229"}], "brand_name": "HYDRALAZINE HYDROCHLORIDE", "product_id": "71209-016_4cdbf75c-b17f-4c40-bd7c-7b07668e9659", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "71209-016", "generic_name": "hydralazine hydrochloride", "labeler_name": "Cadila Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HYDRALAZINE HYDROCHLORIDE", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA203845", "marketing_category": "ANDA", "marketing_start_date": "20151229", "listing_expiration_date": "20261231"}