Raxibacumab Liquid
NDC Package 49401-080-92

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.

Raxibacumab liquids is a bulk ingredient utilized for pharmaceutical compounding or manufacturing. This formulation utilizes a liquid delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 49401-080.

Identification & Billing

NDC Package Code
49401-080-92
Package Description
7 kg in 1 BAG
Product Code
49401-080
11-Digit Billing Format
49401008092

Clinical Specifications

Proprietary Name
Raxibacumab
Non-Proprietary Name
Raxibacumab
Substance Name
Raxibacumab
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)
RAXIBACUMAB 1 kg/kg

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Bulk Ingredient
Marketing Category
BULK INGREDIENT - A category specifying that a product is marketed as a bulk ingredient.
Start Marketing Date
04-09-2018
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 49401-080-92 identifies a specific commercial package of 7 kg in 1 bag of Raxibacumab (UNFINISHED drug), a bulk ingredient labeled by Glaxosmithkline Llc. This liquid is formulated for use and contains raxibacumab 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 Glaxosmithkline Llc on April 09, 2018. The current certification is valid through December 31, 2026.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49401008092. 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)
49401-080-92
11-Digit CMS (5-4-2)
49401-0080-92

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