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  5. NDC Package Code: 66658-113-03 Kepivance

NDC Package 66658-113-03 Kepivance

Palifermin Injection, Powder, Lyophilized, For Solution Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

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:
66658-113-03
Package Description:
3 VIAL, SINGLE-USE in 1 CARTON / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)
Product Code:
66658-113
Proprietary Name:
Kepivance
Non-Proprietary Name:
Palifermin
Substance Name:
Palifermin
Usage Information:
Kepivance is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients. Kepivance is a mucocutaneous epithelial human growth factor indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy in the setting of autologous hematopoietic stem cell support. Kepivance is indicated as supportive care for preparative regimens predicted to result in ≥ WHO Grade 3 mucositis in the majority of patients.
11-Digit NDC Billing Format:
66658011303
NDC to RxNorm Crosswalk:
  • RxCUI: 2643434 - palifermin 5.16 MG Injection
  • RxCUI: 2643436 - Kepivance 5.16 MG Injection
  • RxCUI: 2643436 - palifermin 5.16 MG Injection [Kepivance]
  • RxCUI: 486510 - palifermin 6.25 MG Injection
  • RxCUI: 545357 - Kepivance 6.25 MG Injection
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Swedish Orphan Biovitrum Ab (publ)
    Dosage Form:
    Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • PALIFERMIN 5.16 mg/1.2mL
    • Pharmacologic Class(es):
  • Fibroblast Growth Factor 7 - [CS]
  • Increased Epithelial Proliferation - [PE] (Physiologic Effect)
  • Mucocutaneous Epithelial Cell Growth Factor - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    BLA125103
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    08-04-2023
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    66658-113-066 VIAL, SINGLE-USE in 1 CARTON / 1.2 mL in 1 VIAL, SINGLE-USE (66658-113-01)

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 66658-113-03?

    The NDC Packaged Code 66658-113-03 is assigned to a package of 3 vial, single-use in 1 carton / 1.2 ml in 1 vial, single-use (66658-113-01) of Kepivance, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). The product's dosage form is injection, powder, lyophilized, for solution and is administered via intravenous form.

    Is NDC 66658-113 included in the NDC Directory?

    Yes, Kepivance with product code 66658-113 is active and included in the NDC Directory. The product was first marketed by Swedish Orphan Biovitrum Ab (publ) on August 04, 2023 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 11-digit format for NDC 66658-113-03?

    The 11-digit format is 66658011303. 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 5-3-2 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
    5-3-266658-113-035-4-266658-0113-03