NDC 70121-1754 Alymsys

Bevacizumab-maly Injection, Solution Intravenous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
70121-1754
Proprietary Name:
Alymsys
Non-Proprietary Name: [1]
Bevacizumab-maly
Substance Name: [2]
Bevacizumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route(s): [4]
  • Intravenous - Administration within or into a vein or veins.
  • Labeler Name: [5]
    Amneal Pharmaceuticals Llc
    Labeler Code:
    70121
    FDA Application Number: [6]
    BLA761231
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    04-15-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 70121-1754-1

    Package Description: 1 VIAL in 1 CARTON / 4 mL in 1 VIAL

    NDC Code 70121-1754-7

    Package Description: 10 VIAL in 1 CARTON / 4 mL in 1 VIAL

    Product Details

    What is NDC 70121-1754?

    The NDC code 70121-1754 is assigned by the FDA to the product Alymsys which is a human prescription drug product labeled by Amneal Pharmaceuticals Llc. The generic name of Alymsys is bevacizumab-maly. The product's dosage form is injection, solution and is administered via intravenous form. The product is distributed in 2 packages with assigned NDC codes 70121-1754-1 1 vial in 1 carton / 4 ml in 1 vial, 70121-1754-7 10 vial in 1 carton / 4 ml in 1 vial. 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 Alymsys?

    This medication is a man-made antibody (IgG1) used to treat various types of cancer. This drug works by blocking a certain protein (vascular endothelial growth factor-VEGF) thereby decreasing the blood supply to the tumor and slowing tumor growth. This monograph is about the following bevacizumab products: bevacizumab, bevacizumab-awwb, and bevacizumab-bvzr.

    What are Alymsys 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.
    • BEVACIZUMAB 100 mg/4mL - An anti-VEGF humanized murine monoclonal antibody. It inhibits VEGF RECEPTORS and helps to prevent PATHOLOGIC ANGIOGENESIS.

    Which are Alymsys UNII Codes?

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

    Which are Alymsys 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 Alymsys?

    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 Alymsys?

    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

    Bevacizumab Injection


    Bevacizumab injection products are used in combination with other chemotherapy medications to treat certain types of colon and rectal cancer (cancer that begins in the large intestine), non-small cell lung cancer (NSCLC), glioblastoma (a certain type of cancerous brain tumor), renal cell cancer (RCC, a type of cancer that begins in the kidney), cervical cancer (cancer that begins in the opening of the uterus [womb]), and ovarian (female reproductive organs where eggs are formed), fallopian tube (tube that transports eggs released by the ovaries to the uterus), or peritoneal (layer of tissue that lines the abdomen) cancer. Bevacizumab (Avastin) is also used in combination with atezolizumab (Tecentriq) to treat hepatocellular carcinoma (HCC) that has spread or cannot be removed by surgery in people who have not previously received chemotherapy. Bevacizumab injection products are in a class of medications called antiangiogenic agents. They work by stopping the formation of blood vessels that bring oxygen and nutrients to tumors. This may slow the growth and spread of tumors.
    [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".