dexrazoxane

Generic: dexrazoxane for injection

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexrazoxane
Generic Name dexrazoxane for injection
Labeler gland pharma limited
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexrazoxane hydrochloride 500 mg/50mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-195
Product ID 68083-195_31a8c608-3ad6-44fe-aec8-621a8b991677
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207321
Listing Expiration 2026-12-31
Marketing Start 2016-12-05

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083195
Hyphenated Format 68083-195

Supplemental Identifiers

RxCUI
1736585 1736590
UPC
0368083388010 0368083195014
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 for injection (source: ndc)
Application Number ANDA207321 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL
source: ndc

Packages (1)

68083-195-01 1 VIAL in 1 CARTON (68083-195-01) / 50 mL in 1 VIAL

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": "31a8c608-3ad6-44fe-aec8-621a8b991677", "openfda": {"upc": ["0368083388010", "0368083195014"], "unii": ["5346058Q7S"], "rxcui": ["1736585", "1736590"], "spl_set_id": ["c9c625fc-8852-4ed4-bcf2-63f46a706782"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (68083-195-01)  / 50 mL in 1 VIAL", "package_ndc": "68083-195-01", "marketing_start_date": "20161205"}], "brand_name": "Dexrazoxane", "product_id": "68083-195_31a8c608-3ad6-44fe-aec8-621a8b991677", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "68083-195", "generic_name": "Dexrazoxane for Injection", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dexrazoxane", "active_ingredients": [{"name": "DEXRAZOXANE HYDROCHLORIDE", "strength": "500 mg/50mL"}], "application_number": "ANDA207321", "marketing_category": "ANDA", "marketing_start_date": "20161205", "listing_expiration_date": "20261231"}