hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler american health packaging
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 60687-833
Product ID 60687-833_22cbafb8-fd5b-19b1-e063-6394a90a2b4e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040858
Listing Expiration 2026-12-31
Marketing Start 2024-03-15

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60687833
Hyphenated Format 60687-833

Supplemental Identifiers

RxCUI
905199 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 ANDA040858 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (60687-833-01) / 1 TABLET in 1 BLISTER PACK (60687-833-11)
source: ndc

Packages (1)

60687-833-01 100 BLISTER PACK in 1 CARTON (60687-833-01) / 1 TABLET in 1 BLISTER PACK (60687-833-11)

Ingredients (1)

hydralazine hydrochloride (50 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": "22cbafb8-fd5b-19b1-e063-6394a90a2b4e", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905199", "905225", "905395"], "spl_set_id": ["2e82655e-8435-46fa-b734-8e7c6e803453"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (60687-833-01)  / 1 TABLET in 1 BLISTER PACK (60687-833-11)", "package_ndc": "60687-833-01", "marketing_start_date": "20240315"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "60687-833_22cbafb8-fd5b-19b1-e063-6394a90a2b4e", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "60687-833", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA040858", "marketing_category": "ANDA", "marketing_start_date": "20240315", "listing_expiration_date": "20261231"}