hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: mylan institutional inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler mylan institutional inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Mylan Institutional Inc.

Identifiers & Regulatory

Product NDC 51079-076
Product ID 51079-076_3a8625af-ede6-2b68-e063-6394a90a4536
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088468
Listing Expiration 2026-12-31
Marketing Start 2007-12-26

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51079076
Hyphenated Format 51079-076

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 ANDA088468 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (51079-076-20) / 1 TABLET in 1 BLISTER PACK (51079-076-01)
source: ndc

Packages (1)

51079-076-20 100 BLISTER PACK in 1 CARTON (51079-076-20) / 1 TABLET in 1 BLISTER PACK (51079-076-01)

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": "3a8625af-ede6-2b68-e063-6394a90a4536", "openfda": {"unii": ["FD171B778Y"], "rxcui": ["905199", "905225", "905395"], "spl_set_id": ["493a8b7e-5bb1-4db2-91a7-77ed87864131"], "manufacturer_name": ["Mylan Institutional Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (51079-076-20)  / 1 TABLET in 1 BLISTER PACK (51079-076-01)", "package_ndc": "51079-076-20", "marketing_start_date": "20071226"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "51079-076_3a8625af-ede6-2b68-e063-6394a90a4536", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "51079-076", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Mylan Institutional Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA088468", "marketing_category": "ANDA", "marketing_start_date": "20071226", "listing_expiration_date": "20261231"}