hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: ascend laboratories, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler ascend laboratories, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 50 mg/1

Manufacturer
Ascend Laboratories, LLC

Identifiers & Regulatory

Product NDC 67877-291
Product ID 67877-291_26a904df-7070-489e-b0e0-67167a817944
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200737
Listing Expiration 2026-12-31
Marketing Start 2009-11-24

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67877291
Hyphenated Format 67877-291

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0367877293011
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 ANDA200737 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (67877-291-01)
  • 500 TABLET in 1 BOTTLE (67877-291-05)
  • 1000 TABLET in 1 BOTTLE (67877-291-10)
source: ndc

Packages (3)

67877-291-01 100 TABLET in 1 BOTTLE (67877-291-01) 67877-291-05 500 TABLET in 1 BOTTLE (67877-291-05) 67877-291-10 1000 TABLET in 1 BOTTLE (67877-291-10)

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": "26a904df-7070-489e-b0e0-67167a817944", "openfda": {"upc": ["0367877293011"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["e7bfec3d-5222-4a26-8f99-6c2a28e14aa6"], "manufacturer_name": ["Ascend Laboratories, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (67877-291-01)", "package_ndc": "67877-291-01", "marketing_start_date": "20091124"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (67877-291-05)", "package_ndc": "67877-291-05", "marketing_start_date": "20091124"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (67877-291-10)", "package_ndc": "67877-291-10", "marketing_start_date": "20091124"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "67877-291_26a904df-7070-489e-b0e0-67167a817944", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "67877-291", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Ascend Laboratories, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA200737", "marketing_category": "ANDA", "marketing_start_date": "20091124", "listing_expiration_date": "20261231"}