hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 100 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-7973
Product ID 0615-7973_502998b4-a486-4c38-ae3a-a47512d2c58c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040901
Listing Expiration 2026-12-31
Marketing Start 2010-01-01

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06157973
Hyphenated Format 0615-7973

Supplemental Identifiers

RxCUI
905222
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 ANDA040901 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 15 TABLET in 1 BLISTER PACK (0615-7973-05)
  • 30 TABLET in 1 BLISTER PACK (0615-7973-39)
source: ndc

Packages (2)

Ingredients (1)

hydralazine hydrochloride (100 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "502998b4-a486-4c38-ae3a-a47512d2c58c", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905222"], "spl_set_id": ["f07abdec-6d94-45b6-be1b-10a898ea28c2"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BLISTER PACK (0615-7973-05)", "package_ndc": "0615-7973-05", "marketing_start_date": "20221110"}, {"sample": false, "description": "30 TABLET in 1 BLISTER PACK (0615-7973-39)", "package_ndc": "0615-7973-39", "marketing_start_date": "20100101"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "0615-7973_502998b4-a486-4c38-ae3a-a47512d2c58c", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "0615-7973", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA040901", "marketing_category": "ANDA", "marketing_start_date": "20100101", "listing_expiration_date": "20261231"}