NDC 81092-1120 Igalmi

Dexmedetomidine Film Sublingual - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
81092-1120
Proprietary Name:
Igalmi
Non-Proprietary Name: [1]
Dexmedetomidine
Substance Name: [2]
Dexmedetomidine
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Film - A thin layer or coating.
Administration Route(s): [4]
  • Sublingual - Administration beneath the tongue.
  • Labeler Name: [5]
    Bioxcel Therapeutics, Inc.
    Labeler Code:
    81092
    FDA Application Number: [6]
    NDA215390
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    07-01-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    BLUE (C48333 - BLUE WITH 2 DARK BLUE SPOTS)
    Shape:
    RECTANGLE (C48347)
    Size(s):
    22 MM
    Score:
    1
    Flavor(s):
    PEPPERMINT (C73408)

    Product Packages

    NDC Code 81092-1120-1

    Package Description: 10 POUCH in 1 CARTON / 1 FILM in 1 POUCH (81092-1120-0)

    Product Details

    What is NDC 81092-1120?

    The NDC code 81092-1120 is assigned by the FDA to the product Igalmi which is a human prescription drug product labeled by Bioxcel Therapeutics, Inc.. The generic name of Igalmi is dexmedetomidine. The product's dosage form is film and is administered via sublingual form. The product is distributed in a single package with assigned NDC code 81092-1120-1 10 pouch in 1 carton / 1 film in 1 pouch (81092-1120-0). 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 Igalmi?

    IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

    What are Igalmi 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.
    • DEXMEDETOMIDINE 120 ug/1 - An imidazole derivative that is an agonist of ADRENERGIC ALPHA-2 RECEPTORS. It is closely related to MEDETOMIDINE, which is the racemic form of this compound.

    Which are Igalmi UNII Codes?

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

    Which are Igalmi 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 Igalmi?

    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:

    Which are the Pharmacologic Classes for Igalmi?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Dexmedetomidine Sublingual and Buccal


    Dexmedetomidine is used to treat episodes of agitation in people who have schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions) or bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of severe mania, and other abnormal moods). Dexmedetomidine is in a class of medications called alpha2 receptor agonists. It works by changing the activity of certain natural substances in the brain.
    [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".