Kepivance Injection, Powder, Lyophilized, For Solution
NDC Package 66658-113-03

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

Package Information

Kepivance (palifermin) injection is 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. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Swedish Orphan Biovitrum Ab (publ), this product is identified by NDC 66658-113 and is authorized under FDA application BLA125103.

Identification & Billing

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
11-Digit Billing Format
66658011303
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kepivance
Non-Proprietary Name
Palifermin
Substance Name
Palifermin
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
PALIFERMIN 5.16 mg/1.2mL
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Swedish Orphan Biovitrum Ab (publ)
Product Type
Human Prescription Drug
FDA Application #
BLA125103
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
08-04-2023
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 66658-113-03 identifies a specific commercial 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). This injection, powder, lyophilized, for solution is formulated for intravenous use and contains palifermin 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 Swedish Orphan Biovitrum Ab (publ) on August 04, 2023. The current certification is valid through December 31, 2026.

How is this Swedish Orphan Biovitrum Ab (publ) product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66658011303. 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 (5-3-2)
66658-113-03
11-Digit CMS (5-4-2)
66658-0113-03

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