Ontruzant Injection, Powder, Lyophilized, For Solution
NDC Package 78206-147-01

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

Ontruzant (trastuzumab) injection is trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called HER2 protein. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Organon Llc, this product is identified by NDC 78206-147 and is authorized under FDA application BLA761100.

Identification & Billing

NDC Package Code
78206-147-01
Package Description
1 VIAL, SINGLE-DOSE in 1 CARTON / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (78206-147-99)
Product Code
78206-147
11-Digit Billing Format
78206014701
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ontruzant
Non-Proprietary Name
Trastuzumab
Substance Name
Trastuzumab
Dosage Form
Injection, Powder, Lyophilized, For Solution - A dosage form intended for the solution prepared by lyophilization ("freeze drying"), a process which involves the removal of water from products in the frozen state at extremely low pressures; this is intended for subsequent addition of liquid to create a solution that conforms in all respects to the requirements for Injections.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
TRASTUZUMAB 150 mg/1
Pharmacologic Class
Usage Information
Trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called 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 monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp.

Regulatory & Marketing

Labeler Name
Organon Llc
Product Type
Human Prescription Drug
FDA Application #
BLA761100
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
06-01-2021
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.

Q5112
Source: ASP
Inj ontruzant 10 mg
HCPCS Dosage 10 MG
Units / Pkg 15

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 78206-147-01 identifies a specific commercial package of 1 vial, single-dose in 1 carton / 1 injection, powder, lyophilized, for solution in 1 vial, single-dose (78206-147-99) of Ontruzant, a human prescription drug labeled by Organon Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, lyophilized, for solution is formulated for intravenous use and contains 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 Organon Llc on June 01, 2021. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

Trastuzumab is used to treat certain breast or stomach cancers that produce more than the normal amount of a certain substance called 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 monograph is about the following trastuzumab products: trastuzumab, trastuzumab-anns, trastuzumab-dkst, trastuzumab-dttb, trastuzumab-pkrb, trastuzumab-qyyp.

How is this Organon Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78206014701. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
78206-147-01
11-Digit CMS (5-4-2)
78206-0147-01

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