Margenza Injection, Solution, Concentrate
NDC Package 74527-022-03

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

Package Information

Margenza (margetuximab-cmkb) injection is mARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. This formulation utilizes a injection, solution, concentrate delivery system. Marketed by Macrogenics, Inc, this product is identified by NDC 74527-022 and is authorized under FDA application BLA761150.

Identification & Billing

NDC Package Code
74527-022-03
Package Description
4 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)
Product Code
74527-022
11-Digit Billing Format
74527002203
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Margenza
Non-Proprietary Name
Margetuximab-cmkb
Substance Name
Margetuximab
Dosage Form
Injection, Solution, Concentrate - A sterile preparation for parenteral use which, upon the addition of suitable solvents, yields a solution conforming in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
MARGETUXIMAB 25 mg/mL
Pharmacologic Class
Usage Information
MARGENZA is indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease [see Dosage and Administration (2.1) and Clinical Studies (14.1)].

Regulatory & Marketing

Labeler Name
Macrogenics, Inc
Product Type
Human Prescription Drug
FDA Application #
BLA761150
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
01-15-2021
Listing Expiration
12-31-2026
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.

J9353
Source: ASP
Inj. margetuximab-cmkb, 5 mg
HCPCS Dosage 5 MG
Units / Pkg 200

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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (74527-022). Click a package code to view its specific billing and regulatory data.

74527-022-02
1 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (74527-022-01)

* 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 74527-022-03 identifies a specific commercial package of 4 vial, single-dose in 1 carton / 10 ml in 1 vial, single-dose (74527-022-01) of Margenza, a human prescription drug labeled by Macrogenics, Inc. This injection, solution, concentrate is formulated for intravenous use and contains margetuximab 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 Macrogenics, Inc on January 15, 2021. The current certification is valid through December 31, 2026.

How is this Macrogenics, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 74527002203. 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)
74527-022-03
11-Digit CMS (5-4-2)
74527-0022-03

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