Dexrazoxane
NDC Package 47781-578-07
Package Information
Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Marketed by Alvogen Inc., this product is identified by NDC 47781-578 and is authorized under FDA application ANDA207321.
Identification & Billing
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 47781 - Alvogen Inc.
- 47781-578 - Dexrazoxane
- 47781-578-07 - 1 VIAL, SINGLE-DOSE in 1 CARTON / 50 mL in 1 VIAL, SINGLE-DOSE
- 47781-578 - Dexrazoxane
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
* Please review the full disclaimer at the bottom of this page.
Billing & HCPCS Mapping
To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.
Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.
* Please review the full disclaimer at the bottom of this page.
Frequently Asked Questions
What is the distribution configuration for this product package?
The code 47781-578-07 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 50 ml in 1 vial, single-dose of Dexrazoxane, labeled by Alvogen Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This is formulated for use and contains as the active substance.
Is this product currently listed with the FDA?
This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Alvogen Inc. on September 01, 2017. The current certification is valid through December 01, 2021.
What are the primary indications for this medication?
Dexrazoxane is used to reduce the risk and severity of heart damage caused by doxorubicin treatment and similar cancer chemotherapy medications. Heart damage limits the length of time you can be treated with doxorubicin. Dexrazoxane allows you to continue doxorubicin treatment for longer. When used for this purpose, dexrazoxane treatment is usually started after you have received several doses of doxorubicin. It is usually not given with the first doses of doxorubicin since doing so may reduce the effectiveness of doxorubicin.
How is this Alvogen Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 47781057807. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
