Esperoct Kit
NDC Package 0169-8055-01

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

Package Information

Esperoct (antihemophilic factor (recombinant), glycopegylated-exei) kits is eSPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for:•On-demand treatment and control of bleeding episodes•Perioperative management of bleeding•Routine prophylaxis to reduce the frequency of bleeding episodesLimitation of Use:ESPEROCT is not indicated for the treatment of von Willebrand disease. This formulation utilizes a kit delivery system. Marketed by Novo Nordisk, this product is identified by NDC 0169-8055 and is authorized under FDA application BLA125671.

Identification & Billing

NDC Package Code
0169-8055-01
Package Description
1 KIT in 1 KIT * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8051-11)
Product Code
0169-8055
11-Digit Billing Format
00169805501
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Esperoct
Non-Proprietary Name
Antihemophilic Factor (recombinant), Glycopegylated-exei
Dosage Form
Kit - A packaged collection of related material.
Usage Information
ESPEROCT [antihemophilic factor (recombinant), glycopegylated-exei] is a recombinant DNA-derived coagulation Factor VIII concentrate indicated for use in adults and children with hemophilia A for:•On-demand treatment and control of bleeding episodes•Perioperative management of bleeding•Routine prophylaxis to reduce the frequency of bleeding episodesLimitation of Use:ESPEROCT is not indicated for the treatment of von Willebrand disease. (1)

Regulatory & Marketing

Labeler Name
Novo Nordisk
Product Type
Plasma Derivative
FDA Application #
BLA125671
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-19-2019
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 0169-8055-01 identifies a specific commercial package of 1 kit in 1 kit * 4 ml in 1 syringe, glass (0169-8008-98) * 4 ml in 1 vial, glass (0169-8051-11) of Esperoct, 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 February 19, 2019. The current certification is valid through December 31, 2026.

How is this Novo Nordisk product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00169805501. 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)
0169-8055-01
11-Digit CMS (5-4-2)
00169-8055-01

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