Herceptin Hylecta Injection, Solution
NDC 50242-077

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 50242-077?
  4. Herceptin Hylecta Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes
  9. Patient Education

Product Information

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) is a BLA-approved product labeled by Genentech, Inc.. Trastuzumab is used to treat a certain type of breast cancer that makes more than usual amounts of a substance in your body (HER2 protein). It is supplied as a injection, solution for subcutaneous administration. This product entry covers the primary NDC 50242-077 and 2 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50242-077
Proprietary Name:
Herceptin Hylecta
Non-Proprietary Name: [1]
Trastuzumab And Hyaluronidase-oysk
Substance Name: [2]
Hyaluronidase (human Recombinant); Trastuzumab
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

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 & Regulatory Data

Labeler Name: [5]
Genentech, Inc.
Labeler Code:
50242
Product Label ID:
ebf30894-41cf-480c-8bc3-56f592a13813
HCPCS Code:
J9356 - Inj. herceptin hylecta, 10mg
FDA Application Number: [6]
BLA761106
Marketing Category: [8]
BLA - A product marketed under an approved Biologic License Application.

Marketing Timeline

Start Marketing Date: [9]
02-28-2019
Listing Expiration Date: [11]
12-31-2027
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 50242-077?

The NDC code 50242-077 is assigned by the FDA to the product Herceptin Hylecta. It is commonly known by its generic name, trastuzumab and hyaluronidase-oysk. This pharmaceutical product is labeled by Genentech, Inc. and is currently categorized as listed product. The medication is a injection, solution administered via subcutaneous route. In terms of distribution, this product is available in 2 different package configurations. The associated package NDC(s) include: 50242-077-01, 50242-077-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Trastuzumab is used to treat a certain type of breast cancer that makes more than usual amounts of a substance in your body (HER2 protein). Trastuzumab belongs to a class of medications known as monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. This product also contains hyaluronidase, which helps your body absorb trastuzumab given by injection under the skin. This monograph is about the following trastuzumab products: trastuzumab (subcutaneous) and trastuzumab-hyaluronidase-oysk. These products are not the same as other trastuzumab products, including trastuzumab emtansine, or trastuzumab given by injection into a vein, and should not be used in place of each other.

What are Active Ingredients of this product?

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 the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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:

Which are the Pharmacologic Classes of this product?

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 full disclaimer at the bottom of this page.

Patient Education

Trastuzumab and Hyaluronidase-oysk Injection


Trastuzumab and hyaluronidase-oysk injection is used along with other medications or after other medications have already been used to treat a certain type of breast cancer that has spread to other parts of the body. Trastuzumab and hyaluronidase-oysk injection is also used during and after treatment with other medications to decrease the chance that a certain type of breast cancer will return. Trastuzumab and hyaluronidase-oysk injection is in a class of medications called monoclonal antibodies. It works by stopping the growth of cancer cells.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
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.
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.
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.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".