Ogivri Injection, Powder, Lyophilized, For Solution
NDC Package 83257-003-01

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

Package Information

Ogivri (trastuzumab-dkst) 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 Biocon Biologics Inc., this product is identified by NDC 83257-003 and is authorized under FDA application BLA761074.

Identification & Billing

NDC Package Code
83257-003-01
Package Description
1 VIAL, MULTI-DOSE in 1 CARTON / 20 mL in 1 VIAL, MULTI-DOSE
Product Code
83257-003
11-Digit Billing Format
83257000301
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ogivri
Non-Proprietary Name
Trastuzumab-dkst
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 420 mg/20mL
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
Biocon Biologics Inc.
Product Type
Human Prescription Drug
FDA Application #
BLA761074
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
10-01-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83257-003-01 identifies a specific commercial package of 1 vial, multi-dose in 1 carton / 20 ml in 1 vial, multi-dose of Ogivri, a human prescription drug labeled by Biocon Biologics Inc.. 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 Biocon Biologics Inc. on October 01, 2023. The current certification is valid through December 31, 2026.

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 Biocon Biologics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83257000301. 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)
83257-003-01
11-Digit CMS (5-4-2)
83257-0003-01

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