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  4. NDC Product Code: 0003-3756 Opdivo

NDC 0003-3756 Opdivo

Nivolumab Injection Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 0003-3756?
  4. Opdivo Uses
  5. Active Ingredients
  6. Pharmacologic Classes
  7. Patient Education

Product Information

NDC Product Code:
0003-3756
Proprietary Name:
Opdivo
Non-Proprietary Name: [1]
Nivolumab
Substance Name: [2]
Nivolumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
    • Labeler Name: [5]
    E.r. Squibb & Sons, L.l.c.
    Labeler Code:
    0003
    Product Label ID:
    f570b9c4-6846-4de2-abfa-4d0a4ae4e394
    FDA Application Number: [6]
    BLA125554
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    08-30-2021
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 0003-3756-14

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 12 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 0003-3756?

    The NDC code 0003-3756 is assigned by the FDA to the product Opdivo which is a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Opdivo is nivolumab. The product's dosage form is injection and is administered via intravenous form. The product is distributed in a single package with assigned NDC code 0003-3756-14 1 vial, single-dose in 1 carton / 12 ml in 1 vial, single-dose. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Opdivo?

    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.

    What are Opdivo Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • NIVOLUMAB 10 mg/mL - A genetically engineered, fully humanized immunoglobulin G4 monoclonal antibody that binds to the PD-1 RECEPTOR, activating an immune response to tumor cells. It is used as monotherapy or in combination with IPILIMUMAB for the treatment of advanced malignant MELANOMA. It is also used in the treatment of advanced or recurring NON-SMALL CELL LUNG CANCER; RENAL CELL CARCINOMA; and HODGKIN'S LYMPHOMA.

    Which are the Pharmacologic Classes for Opdivo?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Nivolumab Injection


    Nivolumab injection is used alone or in combination with ipilimumab (Yervoy) to treat certain types of melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be removed by surgery. It is also used alone to prevent melanoma from returning after surgery. Nivolumab injection is also used in alone or in combination with ipilimumab and/or other chemotherapy medications to treat certain types of lung cancer (non-small cell lung cancer; NSCLC), renal cell cancer (a type of cancer that begins in the cells of the kidneys), Hodgkin's lymphoma (Hodgkin's disease), head and neck cancer, urothelial cancer (cancer of the lining of the bladder and other parts of the urinary tract), colorectal cancer (cancer that begins in the large intestine), hepatocellular carcinoma (HCC; a type of liver cancer), esophageal cancer (cancer of the tube that connects your throat to your stomach), gastric cancer (cancer of the stomach) or gastroesophageal junction cancer (cancer located in the area where the stomach meets the esophagus), and malignant pleural mesothelioma (a type of cancer that affects the inside lining of the lungs and chest cavity). Nivolumab is in a class of medications called monoclonal antibodies. It works by helping your immune system to slow or stop the growth of cancer cells. Your doctor will review your specific type of cancer and past treatment history and other available treatments to determine if nivolumab is right for you.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".