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  5. NDC Package Code: 0003-3772-11 Opdivo

NDC Package 0003-3772-11 Opdivo

Nivolumab 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:
0003-3772-11
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 4 mL in 1 VIAL, SINGLE-DOSE
Product Code:
0003-3772
Proprietary Name:
Opdivo
Non-Proprietary Name:
Nivolumab
Substance Name:
Nivolumab
Usage Information:
Nivolumab is used to treat cancer. It works by changing the action of your own immune system, directing it to attack cancer cells. Nivolumab belongs to a class of drugs known as monoclonal antibodies.
11-Digit NDC Billing Format:
00003377211
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
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 10 mg/mL
    • Pharmacologic Class(es):
  • 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:
    BLA125554
    Marketing Category:
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date:
    12-22-2014
    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 0003-3772-11 HCPCS crosswalk information with package details and bill units information.

    NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
    00003377211J9299Injection, nivolumab1 MG414040

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 0003-3772-11?

    The NDC Packaged Code 0003-3772-11 is assigned to a package of 1 vial, single-dose in 1 carton / 4 ml in 1 vial, single-dose of Opdivo, 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 0003-3772 included in the NDC Directory?

    Yes, Opdivo with product code 0003-3772 is active and included in the NDC Directory. The product was first marketed by E.r. Squibb & Sons, L.l.c. on December 22, 2014 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 0003-3772-11?

    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 0003-3772-11?

    The 11-digit format is 00003377211. 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
    4-4-20003-3772-115-4-200003-3772-11