Igalmi Film
NDC Package 81092-1180-3

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

Igalmi (dexmedetomidine) films is iGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults. This formulation utilizes a film delivery system. Marketed by Bioxcel Therapeutics, Inc., this product is identified by NDC 81092-1180 and is authorized under FDA application NDA215390.

Identification & Billing

NDC Package Code
81092-1180-3
Package Description
30 POUCH in 1 CARTON / 1 FILM in 1 POUCH (81092-1180-0)
Product Code
81092-1180
11-Digit Billing Format
81092118003
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
30 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Igalmi
Non-Proprietary Name
Dexmedetomidine
Substance Name
Dexmedetomidine
Dosage Form
Film - A thin layer or coating.
Administration Route
Sublingual - Administration beneath the tongue.
Active Ingredient(s)
DEXMEDETOMIDINE 180 ug/1
Pharmacologic Class
Usage Information
IGALMI is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.

Regulatory & Marketing

Labeler Name
Bioxcel Therapeutics, Inc.
Product Type
Human Prescription Drug
FDA Application #
NDA215390
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
07-01-2022
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

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 (81092-1180). Click a package code to view its specific billing and regulatory data.

81092-1180-1
10 POUCH in 1 CARTON / 1 FILM in 1 POUCH (81092-1180-0)

* 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 81092-1180-3 identifies a specific commercial package of 30 pouch in 1 carton / 1 film in 1 pouch (81092-1180-0) of Igalmi, a human prescription drug labeled by Bioxcel Therapeutics, Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 30 billable units per package. This film is formulated for sublingual use and contains dexmedetomidine 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 Bioxcel Therapeutics, Inc. on July 01, 2022. The current certification is valid through December 31, 2027.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81092118003. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 30 total billable units per package. 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 (5-4-1)
81092-1180-3
11-Digit CMS (5-4-2)
81092-1180-03

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