NDC 0003-3774 Opdivo
Nivolumab Injection Intravenous

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 0003-3774?
    4. Opdivo Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Pharmacologic Classes
    10. Patient Education

Product Information

NDC Product Code0003-3774
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Opdivo
Non-Proprietary Name 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.		Nivolumab
Substance Name 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.		Nivolumab
Product Type 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.		Human Prescription Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormInjection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Intravenous - Administration within or into a vein or veins.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		E.r. Squibb & Sons, L.l.c.
Labeler Code0003
SPL SET ID:f570b9c4-6846-4de2-abfa-4d0a4ae4e394
FDA Application Number 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.		BLA125554
Marketing Category 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.		BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		12-22-2014
Listing Expiration Date 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.		12-31-2024
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 0003-3774-12

Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE

Product Details

What is NDC 0003-3774?

The NDC code 0003-3774 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 0003-3774-12 1 vial, single-dose in 1 carton / 10 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 Opdivo UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Opdivo Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Opdivo?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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.
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Cancer Chemotherapy


What is cancer chemotherapy?

Cancer chemotherapy is a type of cancer treatment. It uses medicines to destroy cancer cells.

Normally, the cells in your body grow and die in a controlled way. Cancer cells keep growing without control. Chemotherapy works by killing the cancer cells, stopping them from spreading, or slowing their growth.

Chemotherapy is used to:

  • Treat cancer by curing the cancer, lessening the chance it will return, or stopping or slowing its growth.
  • Ease cancer symptoms by shrinking tumors that are causing pain and other problems.

What are the side effects of chemotherapy?

Chemotherapy does not just destroy cancer cells. It can also harm some healthy cells, which causes side effects.

You may have a lot of side effects, some side effects, or none at all. It depends on the type and amount of chemotherapy you get and how your body reacts.

Some common side effects are:

There are ways to prevent or control some side effects. Talk with your health care provider about how to manage them. Healthy cells usually recover after chemotherapy is over, so most side effects gradually go away.

What can I expect when getting chemotherapy?

You may get chemotherapy in a hospital or at home, a doctor's office, or a medical clinic. You might be given the medicines by mouth, in a shot, as a cream, through a catheter, or intravenously (by IV).

Your treatment plan will depend on the type of cancer you have, which chemotherapy medicines are used, the treatment goals, and how your body responds to the medicines.

Chemotherapy may be given alone or with other treatments. You may get treatment every day, every week, or every month. You may have breaks between treatments so that your body has a chance to build new healthy cells.

NIH: National Cancer Institute


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* Please review the disclaimer below.

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