Enhertu Liquid
NDC Package 83012-020-99

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

Package Information

This product is an UNFINISHED DRUG part of the official NDC directory. Unfinished drugs include products like active ingredients some of which are used in bulk for further processing or compounding. The FDA requires a list of these drugs manufactured in a U.S. commercial distribution facility.

Enhertu liquids 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 liquid delivery system. Marketed by Boehringer Ingelheim Fremont, Inc., this product is identified by NDC 83012-020.

Identification & Billing

NDC Package Code
83012-020-99
Package Description
22 mg in 1 BAG
Product Code
83012-020
11-Digit Billing Format
83012002099

Clinical Specifications

Proprietary Name
Enhertu
Non-Proprietary Name
Enhertu
Substance Name
Trastuzumab
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Active Ingredient(s)
TRASTUZUMAB 22 mg/22mg
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
Boehringer Ingelheim Fremont, Inc.
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
05-20-2019
Listing Expiration
12-31-2026
Exclude Flag
N
Unfinished Product
Yes
Sample Package
N/A

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 83012-020-99 identifies a specific commercial package of 22 mg in 1 bag of Enhertu (UNFINISHED drug), a bulk ingredient labeled by Boehringer Ingelheim Fremont, Inc.. This liquid is formulated for 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 Boehringer Ingelheim Fremont, Inc. on May 20, 2019. 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 Boehringer Ingelheim Fremont, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83012002099. 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)
83012-020-99
11-Digit CMS (5-4-2)
83012-0020-99

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