dexrazoxane

Generic: dexrazoxane

Labeler: auromedics pharma llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name dexrazoxane
Generic Name dexrazoxane
Labeler auromedics pharma llc
Dosage Form KIT
Manufacturer
AuroMedics Pharma LLC

Identifiers & Regulatory

Product NDC 55150-434
Product ID 55150-434_cb72203a-0b09-42d5-bf51-7f479feb3adb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA200752
Listing Expiration 2026-12-31
Marketing Start 2016-05-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150434
Hyphenated Format 55150-434

Supplemental Identifiers

RxCUI
1736585

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 ANDA200752 (source: ndc)

Resolved Composition

Strengths
  • 250 mg
  • 500 mg
  • 25 ml
  • 50 ml
source: label
Packaging
  • 1 KIT in 1 PACKAGE (55150-434-02) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02) * 25 mL in 1 VIAL (55150-433-02)
source: ndc

Packages (1)

55150-434-02 1 KIT in 1 PACKAGE (55150-434-02) * 25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02) * 25 mL in 1 VIAL (55150-433-02)

Ingredients (0)

No ingredient records.

Linked Drug Pages (2)

DEXRAZOXANE ndc-match (0.9) DEXRAZOXANE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "cb72203a-0b09-42d5-bf51-7f479feb3adb", "openfda": {"rxcui": ["1736585"], "spl_set_id": ["cb72203a-0b09-42d5-bf51-7f479feb3adb"], "manufacturer_name": ["AuroMedics Pharma LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 PACKAGE (55150-434-02)  *  25 mL in 1 VIAL, SINGLE-DOSE (55150-432-02)  *  25 mL in 1 VIAL (55150-433-02)", "package_ndc": "55150-434-02", "marketing_start_date": "20160512"}], "brand_name": "DEXRAZOXANE", "product_id": "55150-434_cb72203a-0b09-42d5-bf51-7f479feb3adb", "dosage_form": "KIT", "product_ndc": "55150-434", "generic_name": "DEXRAZOXANE", "labeler_name": "AuroMedics Pharma LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "DEXRAZOXANE", "application_number": "ANDA200752", "marketing_category": "ANDA", "marketing_start_date": "20160512", "listing_expiration_date": "20261231"}