Gobarden Injection, Solution
NDC Package 83831-176-04

11-digit billing NDC: 83831017604
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Gobarden (bendamustine hydrochloride) injection is gOBARDEN is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, polyethylene glycol 300, or butylated hydroxytoluene. This formulation utilizes a injection, solution delivery system. Marketed by Avyxa Pharma, Llc, this product is identified by NDC 83831-176 and is authorized under FDA application NDA219014.

Identification & Billing

NDC Package Code
83831-176-04
Package Description
1 VIAL in 1 CARTON / 4 mL in 1 VIAL
Product Code
83831-176
11-Digit Billing Format
83831017604

Clinical Specifications

Proprietary Name
Gobarden
Non-Proprietary Name
Bendamustine Hydrochloride
Substance Name
Bendamustine Hydrochloride
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
BENDAMUSTINE HYDROCHLORIDE 100 mg/4mL
Pharmacologic Class
Usage Information
GOBARDEN is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, polyethylene glycol 300, or butylated hydroxytoluene. [see Warnings and Precautions (5.4)]

Regulatory & Marketing

Labeler Name
Avyxa Pharma, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA219014
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
09-25-2026
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 83831-176-04 identifies a specific commercial package of 1 vial in 1 carton / 4 ml in 1 vial of Gobarden, a human prescription drug labeled by Avyxa Pharma, Llc. This injection, solution is formulated for intravenous use and contains bendamustine hydrochloride 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 Avyxa Pharma, Llc on September 25, 2026. The current certification is valid through December 31, 2027.

How is this Avyxa Pharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83831017604. 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)
83831-176-04
11-Digit CMS (5-4-2)
83831-0176-04

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