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  5. NDC Package Code: 81968-045-30 Auvelity

NDC Package 81968-045-30 Auvelity

Dextromethorphan Hydrobromide,Bupropion Hydrochloride Tablet, Multilayer, Extended Release - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
81968-045-30
Package Description:
30 TABLET, MULTILAYER, EXTENDED RELEASE in 1 BOTTLE
Product Code:
81968-045
Proprietary Name:
Auvelity
Non-Proprietary Name:
Dextromethorphan Hydrobromide, Bupropion Hydrochloride
Substance Name:
Bupropion Hydrochloride; Dextromethorphan Hydrobromide
Usage Information:
AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.
11-Digit NDC Billing Format:
81968004530
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
30 EA
NDC to RxNorm Crosswalk:
  • RxCUI: 2611260 - buPROPion hydrochloride 105 MG / dextromethorphan hydrobromide 45 MG Extended Release Oral Tablet
  • RxCUI: 2611260 - bupropion hydrochloride 105 MG / dextromethorphan hydrobromide 45 MG Extended Release Oral Tablet
  • RxCUI: 2611266 - Auvelity 105 MG / 45 MG Extended Release Oral Tablet
  • RxCUI: 2611266 - bupropion hydrochloride 105 MG / dextromethorphan hydrobromide 45 MG Extended Release Oral Tablet [Auvelity]
    • Product Type:
    Human Prescription Drug
    Labeler Name:
    Axsome Therapeutics, Inc.
    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(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • BUPROPION HYDROCHLORIDE 105 mg/1
  • DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1
    • Pharmacologic Class(es):
  • Aminoketone - [EPC] (Established Pharmacologic Class)
  • Dopamine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Increased Dopamine Activity - [PE] (Physiologic Effect)
  • Increased Norepinephrine Activity - [PE] (Physiologic Effect)
  • Norepinephrine Uptake Inhibitors - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
    • Sample Package:
    No
    FDA Application Number:
    NDA215430
    Marketing Category:
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date:
    08-18-2022
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 81968-045-30?

    The NDC Packaged Code 81968-045-30 is assigned to a package of 30 tablet, multilayer, extended release in 1 bottle of Auvelity, a human prescription drug labeled by Axsome Therapeutics, Inc.. The product's dosage form is tablet, multilayer, extended release and is administered via oral form.

    Is NDC 81968-045 included in the NDC Directory?

    Yes, Auvelity with product code 81968-045 is active and included in the NDC Directory. The product was first marketed by Axsome Therapeutics, Inc. on August 18, 2022 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 81968-045-30?

    The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 30.

    What is the 11-digit format for NDC 81968-045-30?

    The 11-digit format is 81968004530. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-281968-045-305-4-281968-0045-30