dexrazoxane

Generic: dexrazoxane

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

Drug Facts

Product Profile

Brand Name dexrazoxane
Generic Name dexrazoxane
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexrazoxane hydrochloride 500 mg/1

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9248
Product ID 0143-9248_032583c8-f4e7-4105-b92e-b5c3f96ca80e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076068
Listing Expiration 2026-12-31
Marketing Start 2005-03-31

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439248
Hyphenated Format 0143-9248

Supplemental Identifiers

RxCUI
1736585 1736590
UNII
5346058Q7S

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 dexrazoxane (source: ndc)
Generic Name dexrazoxane (source: ndc)
Application Number ANDA076068 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/1
source: ndc
Packaging
  • 1 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

0143-9248-01 1 VIAL in 1 BOX (0143-9248-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

dexrazoxane hydrochloride (500 mg/1)

Linked Drug Pages (1)

Dexrazoxane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "032583c8-f4e7-4105-b92e-b5c3f96ca80e", "openfda": {"unii": ["5346058Q7S"], "rxcui": ["1736585", "1736590"], "spl_set_id": ["68089182-d4a2-4053-8d0d-fc97a901515d"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 BOX (0143-9248-01)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "0143-9248-01", "marketing_start_date": "20171005"}], "brand_name": "Dexrazoxane", "product_id": "0143-9248_032583c8-f4e7-4105-b92e-b5c3f96ca80e", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "0143-9248", "generic_name": "Dexrazoxane", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexrazoxane", "active_ingredients": [{"name": "DEXRAZOXANE HYDROCHLORIDE", "strength": "500 mg/1"}], "application_number": "ANDA076068", "marketing_category": "ANDA", "marketing_start_date": "20050331", "listing_expiration_date": "20261231"}