Novoseven Kit
NDC Package 0169-7010-01

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

Package Information

Novoseven (coagulation factor viia (recombinant)) kits is a medication used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). This formulation utilizes a kit delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-7010 and is authorized under FDA application BLA103665.

Identification & Billing

NDC Package Code
0169-7010-01
Package Description
1 KIT in 1 KIT * 1 mL in 1 VIAL, GLASS (0169-7017-11) * 1 mL in 1 VIAL, GLASS (0169-7001-98)
Product Code
0169-7010
11-Digit Billing Format
00169701001
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Novoseven RT
Non-Proprietary Name
Coagulation Factor Viia (recombinant)
Dosage Form
Kit - A packaged collection of related material.
Usage Information
This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding.

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Plasma Derivative
FDA Application #
BLA103665
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-30-2008
Listing Expiration
12-31-2026
Exclude Flag
N
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0169-7010-01 identifies a specific commercial package of 1 kit in 1 kit * 1 ml in 1 vial, glass (0169-7017-11) * 1 ml in 1 vial, glass (0169-7001-98) of Novoseven RT, a plasma derivative 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 April 30, 2008. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat and prevent bleeding in people with certain conditions (such as hemophilia type A or B, low levels of factor VII, Glanzmann's thrombasthenia). People with these conditions are at risk for bleeding longer after an injury/surgery and for bleeding inside the body (especially into the joints and muscles). This product contains a man-made form of factor VIIa, which is a protein (clotting factor) in the blood that works with other clotting factors to help the blood clot and therefore stop bleeding.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169701001. 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 (4-4-2)
0169-7010-01
11-Digit CMS (5-4-2)
00169-7010-01

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