Ixinity
NDC Package 53270-0271-5

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Ixinity is a medication used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Marketed by Cangene Biopharma, this product is identified by NDC 53270-0271 and is authorized under FDA application BLA125426.

Identification & Billing

NDC Package Code
53270-0271-5
Package Description
1 KIT in 1 CARTON * 5 mL in 1 VIAL * 5 mL in 1 SYRINGE (53270-0280-1)
Product Code
53270-0271
11-Digit Billing Format
53270027105
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.

Clinical Specifications

Proprietary Name
Ixinity
Dosage Form
-
Usage Information
This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

Regulatory & Marketing

Labeler Name
Cangene Biopharma
FDA Application #
BLA125426
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
05-01-2015
End Marketing Date
05-31-2018
Listing Expiration
05-31-2018
Exclude Flag
D
Sample Package
No

Hierarchy Structure

Code Lineage

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (53270-0271). Click a package code to view its specific billing and regulatory data.

53270-0271-6
2 KIT in 1 CARTON / 1 KIT in 1 KIT * 5 mL in 1 VIAL * 5 mL in 1 SYRINGE (53270-0280-1)

* 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 53270-0271-5 identifies a specific commercial package of 1 kit in 1 carton * 5 ml in 1 vial * 5 ml in 1 syringe (53270-0280-1) of Ixinity, labeled by Cangene Biopharma. 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 Cangene Biopharma on May 01, 2015. The current certification is valid through May 31, 2018.

What are the primary indications for this medication?

This medication is used to prevent or control bleeding in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding. People with little or no factor IX are at risk for bleeding longer after an injury/surgery or bleeding suddenly (often in the joints/muscle) without an obvious cause. This medication should not be used to treat other types of factor deficiencies (e.g., factors II, VII, VIII, X) or factor problems (e.g., inhibitor to factor XIII), to reverse the effects of "blood thinners" (e.g., warfarin), or to treat bleeding from low levels of liver-dependent clotting factors (due to liver problems).

How is this Cangene Biopharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53270027105. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. 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:

10-Digit Format (5-4-1)
53270-0271-5
11-Digit CMS (5-4-2)
53270-0271-05

Note: The zero is added to the Package segment to maintain the 5-4-2 structure.