Brenzavvy Tablet
NDC Package 82381-2174-2

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

Package Information

Brenzavvy (bexagliflozin) tablets is bRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use BRENZAVVY is not recommended in patients with type 1 diabetes mellitus. This formulation utilizes a tablet delivery system. Marketed by Theracosbio, Llc, this product is identified by NDC 82381-2174 and is authorized under FDA application NDA214373.

Identification & Billing

NDC Package Code
82381-2174-2
Package Description
90 TABLET in 1 BOTTLE
Product Code
82381-2174
11-Digit Billing Format
82381217402
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
90 EA

Clinical Specifications

Proprietary Name
Brenzavvy
Non-Proprietary Name
Bexagliflozin
Substance Name
Bexagliflozin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
BEXAGLIFLOZIN 20 mg/1
Pharmacologic Class
Usage Information
BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Limitations of Use BRENZAVVY is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)].

Regulatory & Marketing

Labeler Name
Theracosbio, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA214373
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-13-2023
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (82381-2174). Click a package code to view its specific billing and regulatory data.

82381-2174-1
30 TABLET in 1 BOTTLE

* 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 82381-2174-2 identifies a specific commercial package of 90 tablet in 1 bottle of Brenzavvy, a human prescription drug labeled by Theracosbio, Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 90 billable units per package. This tablet is formulated for oral use and contains bexagliflozin 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 Theracosbio, Llc on July 13, 2023. The current certification is valid through December 31, 2027.

How is this Theracosbio, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82381217402. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 90 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 (5-4-1)
82381-2174-2
11-Digit CMS (5-4-2)
82381-2174-02

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