Herceptin Hylecta Injection, Solution
NDC Package 50242-077-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Frequently Asked Questions

Package Information

Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) injection is 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). This formulation utilizes a injection, solution delivery system. Marketed by Genentech, Inc., this product is identified by NDC 50242-077 and is authorized under FDA application BLA761106.

Identification & Billing

NDC Package Code
50242-077-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
Product Code
50242-077
11-Digit Billing Format
50242007701
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 2119714 - trastuzumab-hyaluronidase-oysk 600 MG / 10,000 UNT in 5 mL Injection
  • RxCUI: 2119714 - 5 ML hyaluronidase-oysk 2000 UNT/ML / trastuzumab-oysk 120 MG/ML Injection
  • RxCUI: 2119714 - trastuzumab-hyaluronidase-oysk 600 MG / 10,000 UNT per 5 ML Injection
  • RxCUI: 2119714 - trastuzumab-oysk 600 MG / hyaluronidase-oysk 10,000 UNT per 5 ML Injection
  • RxCUI: 2119719 - Herceptin Hylecta 600 MG / 10,000 UNT in 5 mL Injection

Clinical Specifications

Proprietary Name
Herceptin Hylecta
Non-Proprietary Name
Trastuzumab And Hyaluronidase-oysk
Substance Name
Hyaluronidase (human Recombinant); Trastuzumab
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
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
Pharmacologic Class
Usage Information
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.

Regulatory & Marketing

Labeler Name
Genentech, Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761106
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
02-28-2019
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

J9356
Source: ASP
Inj. herceptin hylecta, 10mg
HCPCS Dosage 10 MG
Units / Pkg 60

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50242-077-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 5 ml in 1 vial, single-dose of Herceptin Hylecta, a human prescription drug labeled by Genentech, Inc.. This injection, solution is formulated for subcutaneous use and contains hyaluronidase (human recombinant); trastuzumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Genentech, Inc. on February 28, 2019. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

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.

How is this Genentech, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50242007701. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50242-077-01
11-Digit CMS (5-4-2)
50242-0077-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.