dexrazoxane

Generic: dexrazoxane for injection

Labeler: almaject, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexrazoxane
Generic Name dexrazoxane for injection
Labeler almaject, inc.
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

dexrazoxane hydrochloride 500 mg/50mL

Manufacturer
Almaject, Inc.

Identifiers & Regulatory

Product NDC 72611-716
Product ID 72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207321
Listing Expiration 2026-12-31
Marketing Start 2022-06-01

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72611716
Hyphenated Format 72611-716

Supplemental Identifiers

RxCUI
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 for injection (source: ndc)
Application Number ANDA207321 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/50mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

72611-716-72 1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72) / 50 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

dexrazoxane hydrochloride (500 mg/50mL)

Linked Drug Pages (2)

Dexrazoxane ndc-match (0.9) Dexrazoxane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "04d9a64e-d4e5-22d2-bfef-32594ee380d2", "openfda": {"unii": ["5346058Q7S"], "rxcui": ["1736590"], "spl_set_id": ["9cbd2987-10bb-eceb-153d-ee7be1ed0c84"], "manufacturer_name": ["Almaject, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (72611-716-72)  / 50 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "72611-716-72", "marketing_start_date": "20220601"}], "brand_name": "Dexrazoxane", "product_id": "72611-716_04d9a64e-d4e5-22d2-bfef-32594ee380d2", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "72611-716", "generic_name": "Dexrazoxane for Injection", "labeler_name": "Almaject, Inc.", "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": "20220601", "listing_expiration_date": "20261231"}