hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 67544-657
Product ID 67544-657_b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088467
Listing Expiration 2026-12-31
Marketing Start 1990-09-30

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67544657
Hyphenated Format 67544-657

Supplemental Identifiers

RxCUI
905225
UNII
FD171B778Y

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 ANDA088467 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (67544-657-60)
  • 180 TABLET in 1 BOTTLE (67544-657-80)
  • 270 TABLET in 1 BOTTLE (67544-657-92)
source: ndc

Packages (3)

67544-657-60 90 TABLET in 1 BOTTLE (67544-657-60) 67544-657-80 180 TABLET in 1 BOTTLE (67544-657-80) 67544-657-92 270 TABLET in 1 BOTTLE (67544-657-92)

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": "b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905225"], "spl_set_id": ["bfbd5960-ae6b-46f5-adfa-e330d7a21dfa"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (67544-657-60)", "package_ndc": "67544-657-60", "marketing_start_date": "20100621"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (67544-657-80)", "package_ndc": "67544-657-80", "marketing_start_date": "20151207"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (67544-657-92)", "package_ndc": "67544-657-92", "marketing_start_date": "20151117"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "67544-657_b08e0b2c-c3c7-42f4-a43c-5eb32ce5be79", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "67544-657", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA088467", "marketing_category": "ANDA", "marketing_start_date": "19900930", "listing_expiration_date": "20261231"}