Auvelity Kit
NDC Package 81968-345-01
Package Information
Auvelity (dextromethorphan hydrobromide, bupropion hydrochloride) kits is aUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults. This formulation utilizes a kit delivery system. Marketed by Axsome Therapeutics, Inc., this product is identified by NDC 81968-345 and is authorized under FDA application NDA215430.
Identification & Billing
- 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
Regulatory & Marketing
Hierarchy Structure
- 81968 - Axsome Therapeutics, Inc.
- 81968-345 - Auvelity
- 81968-345-01 - 1 KIT in 1 KIT * 1 BOTTLE in 1 CARTON / 14 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 1 BOTTLE in 1 CARTON / 21 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE * 30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
- 81968-345 - Auvelity
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 (81968-345). Click a package code to view its specific billing and regulatory data.
* 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 81968-345-01 identifies a specific commercial package of 1 kit in 1 kit * 1 bottle in 1 carton / 14 tablet, multilayer, extended release in 1 bottle * 1 bottle in 1 carton / 21 tablet, multilayer, extended release in 1 bottle * 30 tablet, multilayer, extended release in 1 bottle of Auvelity, a human prescription drug labeled by Axsome Therapeutics, Inc.. This kit is formulated for use and contains 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 June 01, 2026. 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: 81968034501. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.
