hydralazine hydrochloride

Generic: hydralazine hydrochloride

Labeler: macleods pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydralazine hydrochloride
Generic Name hydralazine hydrochloride
Labeler macleods pharmaceuticals limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydralazine hydrochloride 25 mg/1

Manufacturer
Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-375
Product ID 33342-375_f9f56326-6d72-47d3-89ac-3625b8a6d713
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211010
Listing Expiration 2026-12-31
Marketing Start 2024-08-26

Pharmacologic Class

Classes
arteriolar vasodilation [pe] arteriolar vasodilator [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 33342375
Hyphenated Format 33342-375

Supplemental Identifiers

RxCUI
905199 905222 905225 905395
UPC
0333342377111 0333342375445 0333342374110 0333342376114 0333342374448 0333342376442 0333342377449 0333342375117
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 ANDA211010 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (33342-375-11)
  • 10 BLISTER PACK in 1 CARTON (33342-375-12) / 10 TABLET in 1 BLISTER PACK
  • 1000 TABLET in 1 BOTTLE (33342-375-44)
source: ndc

Packages (3)

33342-375-11 100 TABLET in 1 BOTTLE (33342-375-11) 33342-375-12 10 BLISTER PACK in 1 CARTON (33342-375-12) / 10 TABLET in 1 BLISTER PACK 33342-375-44 1000 TABLET in 1 BOTTLE (33342-375-44)

Ingredients (1)

hydralazine hydrochloride (25 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": "f9f56326-6d72-47d3-89ac-3625b8a6d713", "openfda": {"upc": ["0333342377111", "0333342375445", "0333342374110", "0333342376114", "0333342374448", "0333342376442", "0333342377449", "0333342375117"], "unii": ["FD171B778Y"], "rxcui": ["905199", "905222", "905225", "905395"], "spl_set_id": ["f9f56326-6d72-47d3-89ac-3625b8a6d713"], "manufacturer_name": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (33342-375-11)", "package_ndc": "33342-375-11", "marketing_start_date": "20240826"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (33342-375-12)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "33342-375-12", "marketing_start_date": "20240826"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (33342-375-44)", "package_ndc": "33342-375-44", "marketing_start_date": "20240826"}], "brand_name": "Hydralazine Hydrochloride", "product_id": "33342-375_f9f56326-6d72-47d3-89ac-3625b8a6d713", "dosage_form": "TABLET", "pharm_class": ["Arteriolar Vasodilation [PE]", "Arteriolar Vasodilator [EPC]"], "product_ndc": "33342-375", "generic_name": "Hydralazine Hydrochloride", "labeler_name": "Macleods Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydralazine Hydrochloride", "active_ingredients": [{"name": "HYDRALAZINE HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA211010", "marketing_category": "ANDA", "marketing_start_date": "20240826", "listing_expiration_date": "20261231"}