Axatilimab Solution
NDC Package 83277-005-01

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.

Axatilimab solution is a drug for further processing. This formulation utilizes a solution delivery system. Marketed by Agc Biologics, Inc., this product is identified by NDC 83277-005.

Identification & Billing

NDC Package Code
83277-005-01
Package Description
6000 mL in 1 BAG
Product Code
83277-005
11-Digit Billing Format
83277000501

Clinical Specifications

Proprietary Name
Axatilimab
Non-Proprietary Name
Axatilimab
Substance Name
Axatilimab
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Active Ingredient(s)
AXATILIMAB 50 mg/mL

Regulatory & Marketing

Labeler Name
Agc Biologics, Inc.
Product Type
Drug For Further Processing
Marketing Category
DRUG FOR FURTHER PROCESSING - A drug (other than the bulk ingredient API) that is in an interim stage of manufacture, processing, preparation, or packaging, and not ready for human or animal use.
Start Marketing Date
08-14-2024
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 83277-005-01 identifies a specific commercial package of 6000 ml in 1 bag of Axatilimab (UNFINISHED drug), drug for further processing labeled by Agc Biologics, Inc.. This solution is formulated for use and contains axatilimab 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 Agc Biologics, Inc. on August 14, 2024. The current certification is valid through December 31, 2026.

How is this Agc Biologics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83277000501. 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)
83277-005-01
11-Digit CMS (5-4-2)
83277-0005-01

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