Benlysta Injection, Powder, Lyophilized, For Solution
NDC Package 49401-101-01

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

Package Information

Benlysta (belimumab) injection is a medication used to treat a certain type of lupus, systemic lupus erythematosus, in patients who are receiving other lupus medicines. This formulation utilizes a injection, powder, lyophilized, for solution delivery system. Marketed by Glaxosmithkline Llc, this product is identified by NDC 49401-101 and is authorized under FDA application BLA125370.

Identification & Billing

NDC Package Code
49401-101-01
Package Description
1 VIAL in 1 CARTON / 1.5 mL in 1 VIAL
Product Code
49401-101
11-Digit Billing Format
49401010101
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
Benlysta
Non-Proprietary Name
Belimumab
Substance Name
Belimumab
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)
BELIMUMAB 120 mg/1.5mL
Pharmacologic Class
Usage Information
This medication is used to treat a certain type of lupus, systemic lupus erythematosus, in patients who are receiving other lupus medicines. It works by binding to a protein (found in high levels in patients with active lupus) in the blood and limiting the activity of the protein. It helps decrease the symptoms of lupus. Belimumab is a type of medication called a monoclonal antibody.

Regulatory & Marketing

Labeler Name
Glaxosmithkline Llc
Product Type
Human Prescription Drug
FDA Application #
BLA125370
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
03-10-2011
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49401-101-01 identifies a specific commercial package of 1 vial in 1 carton / 1.5 ml in 1 vial of Benlysta, a human prescription drug labeled by Glaxosmithkline 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 belimumab 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 March 10, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to treat a certain type of lupus, systemic lupus erythematosus, in patients who are receiving other lupus medicines. It works by binding to a protein (found in high levels in patients with active lupus) in the blood and limiting the activity of the protein. It helps decrease the symptoms of lupus. Belimumab is a type of medication called a monoclonal antibody.

How is this Glaxosmithkline Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49401010101. 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)
49401-101-01
11-Digit CMS (5-4-2)
49401-0101-01

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