Gamifant Injection
NDC Package 66658-522-01

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

Package Information

Gamifant (emapalumab-lzsg) injection is a medication used to treat a certain immune system problem (hemophagocytic lymphohistiocytosis - HLH). This formulation utilizes a injection delivery system. Marketed by Swedish Orphan Biovitrum Ab (publ), this product is identified by NDC 66658-522 and is authorized under FDA application BLA761107.

Identification & Billing

NDC Package Code
66658-522-01
Package Description
1 VIAL, SINGLE-USE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-USE
Product Code
66658-522
11-Digit Billing Format
66658052201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Gamifant
Non-Proprietary Name
Emapalumab-lzsg
Substance Name
Emapalumab
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
EMAPALUMAB 50 mg/2mL
Pharmacologic Class
Usage Information
This medication is used to treat a certain immune system problem (hemophagocytic lymphohistiocytosis - HLH).

Regulatory & Marketing

Labeler Name
Swedish Orphan Biovitrum Ab (publ)
Product Type
Human Prescription Drug
FDA Application #
BLA761107
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-07-2023
Listing Expiration
12-31-2027
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 66658-522-01 identifies a specific commercial package of 1 vial, single-use in 1 carton / 2 ml in 1 vial, single-use of Gamifant, a human prescription drug labeled by Swedish Orphan Biovitrum Ab (publ). This injection is formulated for intravenous use and contains emapalumab 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 June 07, 2023. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain immune system problem (hemophagocytic lymphohistiocytosis - HLH).

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: 66658052201. 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)
66658-522-01
11-Digit CMS (5-4-2)
66658-0522-01

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