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  4. NDC Product Code: 81968-045 Auvelity

NDC 81968-045 Auvelity

Dextromethorphan Hydrobromide,Bupropion Hydrochloride Tablet, Multilayer, Extended Release - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 81968-045?
  5. Auvelity Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

NDC Product Code:
81968-045
Proprietary Name:
Auvelity
Non-Proprietary Name: [1]
Dextromethorphan Hydrobromide, Bupropion Hydrochloride
Substance Name: [2]
Bupropion Hydrochloride; Dextromethorphan Hydrobromide
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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): [4]
  • Oral - Administration to or by way of the mouth.
    • Labeler Name: [5]
    Axsome Therapeutics, Inc.
    Labeler Code:
    81968
    Product Label ID:
    dcefda7c-9a68-278e-e053-2995a90aec79
    FDA Application Number: [6]
    NDA215430
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    08-18-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Navigator:

    Product Characteristics

    Color(s):
    BROWN (C48332 - BEIGE)
    Shape:
    ROUND (C48348)
    Size(s):
    11 MM
    Imprint(s):
    45;105
    Score:
    1

    Code Structure Chart

    Product Details

    What is NDC 81968-045?

    The NDC code 81968-045 is assigned by the FDA to the product Auvelity which is a human prescription drug product labeled by Axsome Therapeutics, Inc.. The generic name of Auvelity is dextromethorphan hydrobromide, bupropion hydrochloride. The product's dosage form is tablet, multilayer, extended release and is administered via oral form. The product is distributed in a single package with assigned NDC code 81968-045-30 30 tablet, multilayer, extended release in 1 bottle . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Auvelity?

    AUVELITY is indicated for the treatment of major depressive disorder (MDD) in adults.

    What are Auvelity Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • BUPROPION HYDROCHLORIDE 105 mg/1 - A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.
    • DEXTROMETHORPHAN HYDROBROMIDE 45 mg/1 - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

    Which are Auvelity UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Auvelity Inactive Ingredients UNII Codes?

    The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Auvelity?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • 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]

    Which are the Pharmacologic Classes for Auvelity?

    * Please review the disclaimer below.

    Patient Education

    Bupropion


    Bupropion (Aplenzin, Wellbutrin, Wellbutrin SR, Wellbutrin XL) is used to treat depression. Bupropion (Aplenzin, Wellbutrin XL) is also used to treat seasonal affective disorder (SAD; episodes of depression that occur at the same time each year [usually in the fall and winter but rarely may occur in the spring or summer months]). Bupropion (Zyban) is used to help people stop smoking. Bupropion is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain.
    [Learn More]


    Dextromethorphan


    Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [8] What is the Marketing Category? - Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

    [12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".