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NDC 50242-245 Phesgo

Pertuzumab,Trastuzumab,And Hyaluronidase-zzxf Injection, Solution Subcutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 50242-245?
  4. Phesgo 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 Code:
50242-245
Proprietary Name:
Phesgo
Non-Proprietary Name: [1]
Pertuzumab, Trastuzumab, And Hyaluronidase-zzxf
Substance Name: [2]
Hyaluronidase (human Recombinant); Pertuzumab; Trastuzumab
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]
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
    • Labeler Name: [5]
    Genentech, Inc.
    Labeler Code:
    50242
    Product Label ID:
    27dd5e6b-72cd-458d-a015-cf4dab5800da
    FDA Application Number: [6]
    BLA761170
    Marketing Category: [8]
    BLA - A product marketed under an approved Biologic License Application.
    Start Marketing Date: [9]
    06-29-2020
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 50242-245-01

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE

    NDC Code 50242-245-86

    Package Description: 1 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE

    Product Details

    What is NDC 50242-245?

    The NDC code 50242-245 is assigned by the FDA to the product Phesgo which is a human prescription drug product labeled by Genentech, Inc.. The generic name of Phesgo is pertuzumab, trastuzumab, and hyaluronidase-zzxf. The product's dosage form is injection, solution and is administered via subcutaneous form. The product is distributed in 2 packages with assigned NDC codes 50242-245-01 1 vial, single-dose in 1 carton / 15 ml in 1 vial, single-dose, 50242-245-86 1 vial, single-dose in 1 carton / 15 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 Phesgo?

    PHESGO is contraindicated in patients with known hypersensitivity to pertuzumab, or trastuzumab, or hyaluronidase, or to any of its excipients.

    What are Phesgo 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.

    Which are Phesgo UNII Codes?

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

    Which are Phesgo 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 Phesgo?

    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:
    • RxCUI: 2382604 - pertuzumab-trastuzumab-hyaluronidase-zzxf 1,200 MG / 600 MG / 30,000 UNT in 15 mL Injection
    • RxCUI: 2382604 - 15 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 80 MG/ML / trastuzumab-zzxf 40 MG/ML Injection
    • RxCUI: 2382604 - pertuzumab-trastuzumab-hyaluronidase-zzxf 1,200 MG / 600 MG / 30,000 UNT per 15 ML Injection
    • RxCUI: 2382609 - PHESGO 1,200 MG / 600 MG / 30,000 UNT in 15 ML Injection
    • RxCUI: 2382609 - 15 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 80 MG/ML / trastuzumab-zzxf 40 MG/ML Injection [Phesgo]

    Which are the Pharmacologic Classes for Phesgo?

    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

    Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection


    The combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf is used in combination with chemotherapy to treat certain types of early breast cancer that has spread to nearby tissues. It is also used to treat a certain type of early breast cancer to decrease the chance that a certain type of breast cancer will return. The combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf is also used with docetaxel (Taxotere) to treat certain types of breast cancer that has spread to other parts of the body. Pertuzumab and trastuzumab are in a class of medications called monoclonal antibodies. They work by stopping the growth of cancer cells. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer so that these medications will have a greater effect.
    [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".