hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler glenmark pharmaceuticals inc., usa
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-343
Product ID 68462-343_617acbb5-012a-416f-bf6c-fd766a25711c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090527
Listing Expiration 2026-12-31
Marketing Start 2009-05-29

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68462343
Hyphenated Format 68462-343

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0368462343012 0368462342015 0368462344019 0368462341018
UNII
FD171B778Y

Packaging Origin

Original Packager
true

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 ANDA090527 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68462-343-01)
  • 500 TABLET in 1 BOTTLE (68462-343-05)
  • 1000 TABLET in 1 BOTTLE (68462-343-10)
source: ndc

Packages (3)

68462-343-01 100 TABLET in 1 BOTTLE (68462-343-01) 68462-343-05 500 TABLET in 1 BOTTLE (68462-343-05) 68462-343-10 1000 TABLET in 1 BOTTLE (68462-343-10)

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": "617acbb5-012a-416f-bf6c-fd766a25711c", "openfda": {"upc": ["0368462343012", "0368462342015", "0368462344019", "0368462341018"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["37ba0233-ed75-498a-a067-6220da573653"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68462-343-01)", "package_ndc": "68462-343-01", "marketing_start_date": "20090529"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68462-343-05)", "package_ndc": "68462-343-05", "marketing_start_date": "20090529"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68462-343-10)", "package_ndc": "68462-343-10", "marketing_start_date": "20090529"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "68462-343_617acbb5-012a-416f-bf6c-fd766a25711c", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "68462-343", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA090527", "marketing_category": "ANDA", "marketing_start_date": "20090529", "listing_expiration_date": "20261231"}