dexrazoxane

Generic: dexrazoxane

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexrazoxane
Generic Name dexrazoxane
Labeler novadoz pharmaceuticals llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexrazoxane hydrochloride 500 mg/50mL

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-248
Product ID 72205-248_bdcb7617-046b-4db9-94ba-b10102565868
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216748
Listing Expiration 2026-12-31
Marketing Start 2025-03-26

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205248
Hyphenated Format 72205-248

Supplemental Identifiers

RxCUI
1736585 1736590
UPC
0372205248014 0372205247017
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 ANDA216748 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72205-248-01 1 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

dexrazoxane hydrochloride (500 mg/50mL)

Linked Drug Pages (1)

Dexrazoxane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "bdcb7617-046b-4db9-94ba-b10102565868", "openfda": {"upc": ["0372205248014", "0372205247017"], "unii": ["5346058Q7S"], "rxcui": ["1736585", "1736590"], "spl_set_id": ["a7c01089-85f5-40aa-b679-f53a425b4d68"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72205-248-01)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72205-248-01", "marketing_start_date": "20250409"}], "brand_name": "Dexrazoxane", "product_id": "72205-248_bdcb7617-046b-4db9-94ba-b10102565868", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "72205-248", "generic_name": "Dexrazoxane", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexrazoxane", "active_ingredients": [{"name": "DEXRAZOXANE HYDROCHLORIDE", "strength": "500 mg/50mL"}], "application_number": "ANDA216748", "marketing_category": "ANDA", "marketing_start_date": "20250326", "listing_expiration_date": "20261231"}