Trogarzo Injection, Solution
NDC Package 62064-122-02

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

Trogarzo (ibalizumab) injection is a medication used with other HIV medications to help control HIV infection. This formulation utilizes a injection, solution delivery system. Marketed by Theratechnologies Inc., this product is identified by NDC 62064-122 and is authorized under FDA application BLA761065.

Identification & Billing

NDC Package Code
62064-122-02
Package Description
2 VIAL, SINGLE-USE in 1 CARTON / 1.33 mL in 1 VIAL, SINGLE-USE (62064-122-01)
Product Code
62064-122
11-Digit Billing Format
62064012202
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Trogarzo
Non-Proprietary Name
Ibalizumab
Substance Name
Ibalizumab
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
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
IBALIZUMAB 150 mg/mL
Pharmacologic Class
Usage Information
This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Ibalizumab-uiyk belongs to a class of drugs known as monoclonal antibodies. Ibalizumab-uiyk is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Regulatory & Marketing

Labeler Name
Theratechnologies Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761065
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-20-2018
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.

J1746
Source: PDAC
INJECTION, IBALIZUMAB-UIYK, 10 MG
HCPCS Dosage 10 MG
Units / Pkg

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 62064-122-02 identifies a specific commercial package of 2 vial, single-use in 1 carton / 1.33 ml in 1 vial, single-use (62064-122-01) of Trogarzo, a human prescription drug labeled by Theratechnologies Inc.. This injection, solution is formulated for intravenous use and contains ibalizumab 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 Theratechnologies Inc. on April 20, 2018. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This drug is used with other HIV medications to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Ibalizumab-uiyk belongs to a class of drugs known as monoclonal antibodies. Ibalizumab-uiyk is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

How is this Theratechnologies Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62064012202. 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)
62064-122-02
11-Digit CMS (5-4-2)
62064-0122-02

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