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 100 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-549
Product ID 71610-549_547e8073-67bc-4f54-bcc9-0fb525db6687
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 71610549
Hyphenated Format 71610-549

Supplemental Identifiers

RxCUI
905222 905225 905395
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 ANDA205236 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 2000 TABLET in 1 BOTTLE (71610-549-02)
  • 4200 TABLET in 1 BOTTLE (71610-549-05)
source: ndc

Packages (2)

71610-549-02 2000 TABLET in 1 BOTTLE (71610-549-02) 71610-549-05 4200 TABLET in 1 BOTTLE (71610-549-05)

Ingredients (1)

hydralazine hydrochloride (100 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": "547e8073-67bc-4f54-bcc9-0fb525db6687", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905222", "905225", "905395"], "spl_set_id": ["c2638ae6-a210-490f-8389-bbed6a3229c5"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "2000 TABLET in 1 BOTTLE (71610-549-02)", "package_ndc": "71610-549-02", "marketing_start_date": "20240401"}, {"sample": false, "description": "4200 TABLET in 1 BOTTLE (71610-549-05)", "package_ndc": "71610-549-05", "marketing_start_date": "20210430"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "71610-549_547e8073-67bc-4f54-bcc9-0fb525db6687", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "71610-549", "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": "100 mg/1"}], "application_number": "ANDA205236", "marketing_category": "ANDA", "marketing_start_date": "20210304", "listing_expiration_date": "20261231"}