Auvelity Tablet, Multilayer, Extended Release
NDC Package 81968-045-14

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

Auvelity (dextromethorphan hydrobromide, bupropion hydrochloride) tablets is aUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults. This formulation utilizes a tablet, multilayer, extended release delivery system. Marketed by Axsome Therapeutics, Inc., this product is identified by NDC 81968-045 and is authorized under FDA application NDA215430.

Identification & Billing

NDC Package Code
81968-045-14
Package Description
1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Code
81968-045
11-Digit Billing Format
81968004514
RxNorm Crosswalk
  • RxCUI: 2611260 - dextromethorphan HBr 45 MG / buPROPion HCl 105 MG Extended Release Oral Tablet
  • RxCUI: 2611260 - bupropion hydrochloride 105 MG / dextromethorphan hydrobromide 45 MG Extended Release Oral Tablet
  • RxCUI: 2611260 - bupropion HCl 105 MG / dextromethorphan HBr 45 MG Extended Release Oral Tablet
  • RxCUI: 2611266 - Auvelity 45 MG / 105 MG Extended Release Oral Tablet
  • RxCUI: 2611266 - bupropion hydrochloride 105 MG / dextromethorphan hydrobromide 45 MG Extended Release Oral Tablet [Auvelity]

Clinical Specifications

Proprietary Name
Auvelity
Non-Proprietary Name
Dextromethorphan Hydrobromide, Bupropion Hydrochloride
Substance Name
Bupropion Hydrochloride; Dextromethorphan Hydrobromide
Dosage Form
Tablet, Multilayer, Extended Release - A solid dosage form containing medicinal substances that have been compressed to form a multiple-layered tablet or a tablet-within-a-tablet, the inner tablet being the core and the outer portion being the shell, which, additionally, is covered in a designated coating; the tablet is formulated in such manner as to allow at least a reduction in dosing frequency as compared to that drug presented as a conventional dosage form.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.

Regulatory & Marketing

Labeler Name
Axsome Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215430
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
08-18-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

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 (81968-045). Click a package code to view its specific billing and regulatory data.

81968-045-30
30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
81968-045-31
1 BOTTLE in 1 CARTON / 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
81968-045-60
60 TABLET, MULTILAYER, EXTENDED RELEASE 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 81968-045-14 identifies a specific commercial package of 1 bottle in 1 carton / 14 tablet, multilayer, extended release in 1 bottle of Auvelity, a human prescription drug labeled by Axsome Therapeutics, Inc.. This tablet, multilayer, extended release is formulated for oral use and contains bupropion hydrochloride; dextromethorphan hydrobromide 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 Axsome Therapeutics, Inc. on August 18, 2022. The current certification is valid through December 31, 2027.

How is this Axsome Therapeutics, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81968004514. 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)
81968-045-14
11-Digit CMS (5-4-2)
81968-0045-14

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