Rebinyn Kit
NDC Package 0169-7902-97

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

Rebinyn (coagulation factor ix recombinant, glycopegylated) kits is a medication used to treat and control bleeding episodes in people with little or no factor IX (due to hemophilia B, Christmas disease). This formulation utilizes a kit delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-7902 and is authorized under FDA application BLA125611.

Identification & Billing

NDC Package Code
0169-7902-97
Package Description
1 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11)
Product Code
0169-7902
11-Digit Billing Format
00169790297
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Rebinyn
Non-Proprietary Name
Coagulation Factor Ix Recombinant, Glycopegylated
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat and control bleeding episodes in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein normally found in the blood that helps the blood to thicken (clot) and 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 contains a man-made form of factor IX.

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Human Prescription Drug
FDA Application #
BLA125611
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
12-01-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage
  • 0169 - Novo Nordisk
    • 0169-7902 - Rebinyn
      • 0169-7902-97 - 1 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11)

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 (0169-7902). Click a package code to view its specific billing and regulatory data.

0169-7902-01
1 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-7922-90) * 4 mL in 1 SYRINGE, GLASS (0169-7009-98) * 4 mL in 1 VIAL, GLASS (0169-7922-11)

* 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 0169-7902-97 identifies a specific commercial package of 1 kit in 1 kit * 4 ml in 1 vial, glass (0169-7922-90) * 4 ml in 1 syringe, glass (0169-7009-98) * 4 ml in 1 vial, glass (0169-7922-11) of Rebinyn, a human prescription drug labeled by Novo Nordisk. This kit is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Novo Nordisk on December 01, 2017. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and control bleeding episodes in people with little or no factor IX (due to hemophilia B, Christmas disease). Factor IX is a protein normally found in the blood that helps the blood to thicken (clot) and 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 contains a man-made form of factor IX.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169790297. 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 (4-4-2)
0169-7902-97
11-Digit CMS (5-4-2)
00169-7902-97

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