Tudriqev Injection, Suspension
NDC Package 83616-107-11

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

Package Information

Tudriqev (vusolimogene oderparepvec-wtpg) injection is tUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14)]. This formulation utilizes a injection, suspension delivery system. Marketed by Replimune, Inc., this product is identified by NDC 83616-107 and is authorized under FDA application BLA125827.

Identification & Billing

NDC Package Code
83616-107-11
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 mL in 1 VIAL, SINGLE-DOSE (83616-107-01)
Product Code
83616-107
11-Digit Billing Format
83616010711

Clinical Specifications

Proprietary Name
Tudriqev
Non-Proprietary Name
Vusolimogene Oderparepvec-wtpg
Substance Name
Vusolimogene Oderparepvec
Dosage Form
Injection, Suspension - A liquid preparation, suitable for injection, which consists of solid particles dispersed throughout a liquid phase in which the particles are not soluble. It can also consist of an oil phase dispersed throughout an aqueous phase, or vice-versa.
Administration Route
Intratumor - Administration within a tumor.
Active Ingredient(s)
VUSOLIMOGENE ODERPAREPVEC 10000000 [PFU]/mL
Usage Information
TUDRIQEV™ is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response [ see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

Regulatory & Marketing

Labeler Name
Replimune, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA125827
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
09-04-2026
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 83616-107-11 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 ml in 1 vial, single-dose (83616-107-01) of Tudriqev, a human prescription drug labeled by Replimune, Inc.. This injection, suspension is formulated for intratumor use and contains vusolimogene oderparepvec 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 Replimune, Inc. on September 04, 2026. The current certification is valid through December 31, 2027.

How is this Replimune, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83616010711. 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)
83616-107-11
11-Digit CMS (5-4-2)
83616-0107-11

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