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  5. NDC Package Code: 61755-054-01 Lynozyfic

NDC Package 61755-054-01 Lynozyfic

Linvoseltamab-gcpt Injection, Solution, Concentrate Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. 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:
61755-054-01
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 2.5 mL in 1 VIAL, SINGLE-DOSE (61755-054-00)
Product Code:
61755-054
Proprietary Name:
Lynozyfic
Non-Proprietary Name:
Linvoseltamab-gcpt
Substance Name:
Linvoseltamab
Usage Information:
LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
11-Digit NDC Billing Format:
61755005401
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Regeneron Pharmaceuticals, Inc.
Dosage Form:
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
LINVOSELTAMAB 5 mg/2.5mL
Sample Package:
No
FDA Application Number:
BLA761400
Marketing Category:
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date:
07-02-2025
Listing Expiration Date:
12-31-2026
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.

Frequently Asked Questions

What is NDC 61755-054-01?

The NDC Packaged Code 61755-054-01 is assigned to a package of 1 vial, single-dose in 1 carton / 2.5 ml in 1 vial, single-dose (61755-054-00) of Lynozyfic, a human prescription drug labeled by Regeneron Pharmaceuticals, Inc.. The product's dosage form is injection, solution, concentrate and is administered via intravenous form.

Is NDC 61755-054 included in the NDC Directory?

Yes, Lynozyfic with product code 61755-054 is active and included in the NDC Directory. The product was first marketed by Regeneron Pharmaceuticals, Inc. on July 02, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 61755-054-01?

The 11-digit format is 61755005401. 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
5-3-261755-054-015-4-261755-0054-01