NDC Package 0169-8300-01 Esperoct

Antihemophilic Factor (recombinant),Glycopegylated-exei Kit - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
0169-8300-01
Package Description:
1 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-8301-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8301-11)
Product Code:
Proprietary Name:
Esperoct
Non-Proprietary Name:
Antihemophilic Factor (recombinant), Glycopegylated-exei
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)
11-Digit NDC Billing Format:
00169830001
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
  • RxCUI: 2275724 - antihemophilic factor (recombinant) pegylated-exei 1 UNT Injection
  • RxCUI: 2275729 - ESPEROCT 1 UNT Injection
  • RxCUI: 2275729 - antihemophilic factor (recombinant) pegylated-exei 1 UNT Injection [Esperoct]
  • RxCUI: 2275729 - Esperoct 1 UNT Injection
  • Product Type:
    Plasma Derivative
    Labeler Name:
    Novo Nordisk
    Dosage Form:
    Kit - A packaged collection of related material.
    Sample Package:
    No
    FDA Application Number:
    BLA125671
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    02-19-2019
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0169-8300-01 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00169830001J7204Inj recombin esperoct per iu1 IU1111

    * Please review the disclaimer below.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    0169-8300-931 KIT in 1 KIT * 4 mL in 1 VIAL, GLASS (0169-8301-90) * 4 mL in 1 SYRINGE, GLASS (0169-8008-98) * 4 mL in 1 VIAL, GLASS (0169-8301-11)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0169-8300-01?

    The NDC Packaged Code 0169-8300-01 is assigned to a package of 1 kit in 1 kit * 4 ml in 1 vial, glass (0169-8301-90) * 4 ml in 1 syringe, glass (0169-8008-98) * 4 ml in 1 vial, glass (0169-8301-11) of Esperoct, a plasma derivative labeled by Novo Nordisk. The product's dosage form is kit and is administered via form.

    Is NDC 0169-8300 included in the NDC Directory?

    Yes, Esperoct with product code 0169-8300 is active and included in the NDC Directory. The product was first marketed by Novo Nordisk on February 19, 2019 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0169-8300-01?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units.

    What is the 11-digit format for NDC 0169-8300-01?

    The 11-digit format is 00169830001. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 4-4-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    4-4-20169-8300-015-4-200169-8300-01