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  5. NDC Package Code: 0003-7125-11 Opdualag

NDC Package 0003-7125-11 Opdualag

Nivolumab And Relatlimab-rmbw Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    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:
0003-7125-11
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0003-7125
Proprietary Name:
Opdualag
Non-Proprietary Name:
Nivolumab And Relatlimab-rmbw
Substance Name:
Nivolumab; Relatlimab
Usage Information:
OPDUALAG™ is indicated for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
11-Digit NDC Billing Format:
00003712511
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
  • RxCUI: 2596778 - nivolumab-relatlimab-rmbw 240 MG / 80 MG in 20 ML Injection
  • RxCUI: 2596778 - 20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection
  • RxCUI: 2596778 - nivolumab-relatlimab-rmbw 240 MG / 80 MG per 20 ML Injection
  • RxCUI: 2596784 - Opdualag 240 MG / 80 MG in 20 ML Injection
  • RxCUI: 2596784 - 20 ML nivolumab-rmbw 12 MG/ML / relatlimab-rmbw 4 MG/ML Injection [Opdualag]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    E.r. Squibb & Sons, L.l.c.
    Dosage Form:
    Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
    Administration Route(s):
  • Intravenous - Administration within or into a vein or veins.
    • Active Ingredient(s):
  • NIVOLUMAB 12 mg/mL
  • RELATLIMAB 4 mg/mL
    • Pharmacologic Class(es):
  • Lymphocyte Activation Gene-3 Antagonists - [MoA] (Mechanism of Action)
  • Lymphocyte Activation Gene-3 Blocker - [EPC] (Established Pharmacologic Class)
  • Programmed Death Receptor-1 Blocking Antibody - [EPC] (Established Pharmacologic Class)
  • Programmed Death Receptor-1-directed Antibody Interactions - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    BLA761234
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    03-18-2022
    Listing Expiration Date:
    12-31-2025
    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.

    NDC HCPCS Crosswalk

    This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

    NDC 0003-7125-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00003712511J9298Inj nivol relatlimab 3mg/1mg3 MG - 1 MG2018080

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0003-7125-11?

    The NDC Packaged Code 0003-7125-11 is assigned to a package of 1 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Opdualag, a human prescription drug labeled by E.r. Squibb & Sons, L.l.c.. The product's dosage form is injection and is administered via intravenous form.

    Is NDC 0003-7125 included in the NDC Directory?

    Yes, Opdualag with product code 0003-7125 is active and included in the NDC Directory. The product was first marketed by E.r. Squibb & Sons, L.l.c. on March 18, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 0003-7125-11?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 0003-7125-11?

    The 11-digit format is 00003712511. 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 4-4-2 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
    4-4-20003-7125-115-4-200003-7125-11