Igalmi Film
Product Images NDC 81092-1180

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Igalmi (NDC 81092-1180). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Bioxcel Therapeutics, Inc., these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Figure (Igalmi 01)

An instructional illustration showing hands holding and peeling the back of a rectangular film packet, indicating how to open the packaging for a sublingual film medication. The image includes an arrow pointing to the edge being peeled.*

FDA Label Image

Figure (Igalmi 02)

Instructional illustration showing hands placing or removing IGALMI sublingual film, a prescription drug film containing dexmedetomidine. The image demonstrates handling of the film dosage form intended for sublingual administration.*

FDA Label Image

Figure (Igalmi 03)

An instructional illustration showing a hand holding a small rectangular film strip and peeling it away from a backing. The film strip has two visible blue dots, and an upward arrow indicates the direction for peeling the film from its backing material.*

FDA Label Image

Figure (Igalmi 04)

An instructional illustration showing a hand holding a small rectangular film with a blue circle in the center while using scissors to cut the film. The image likely demonstrates how to prepare or divide the IGALMI sublingual film containing dexmedetomidine.*

FDA Label Image

Figure (Igalmi 05)

An instructional illustration showing a hand holding a small sublingual film, demonstrating proper handling of the IGALMI film dosage form for sublingual administration.*

FDA Label Image

Figure (Igalmi 06)

An instructional illustration showing how to administer IGALMI film sublingually. The image depicts a person placing a small film with a blue dot under the tongue using fingers, indicating the correct placement for sublingual delivery.*

FDA Label Image

Figure (Igalmi 07)

An instructional illustration showing two hands peeling apart a circular container, indicating how to open the packaging for the IGALMI sublingual film.*

FDA Label Image

Figure (Igalmi 08)

An instructional diagram showing the insertion of a thin film strip, marked with three blue dots, into a container held by one hand while the other hand lifts the film upwards, indicating removal or insertion action for IGALMI sublingual film.*

FDA Label Image

Figure (Igalmi 09)

An instructional illustration showing a partially open mouth with a sublingual film placed under the tongue on the floor of the mouth, demonstrating how to administer a sublingual film dosage form.*

FDA Label Image

Figure (Igalmi 10)

Illustration showing a person placing a sublingual film under the tongue. The image depicts the correct administration method for IGALMI (dexmedetomidine) sublingual film by using fingers to position the film and holding the lower lip down for placement.*

FDA Label Image

Chemical Structure (Igalmi 11)

Chemical structure diagram of dexmedetomidine hydrochloride showing the molecular arrangement of atoms including imidazole and aromatic rings, methyl groups, and the hydrochloride component.*

FDA Label Image

Figure 1 (Igalmi 12)

A line graph showing change in PEC score from baseline over time post-dose in minutes, comparing IGALMI film 120 mcg, IGALMI film 180 mcg, and placebo groups. The graph shows mean changes with standard error bars for each group from 0 to 120 minutes post-dose, illustrating a greater decrease in PEC score with IGALMI 180 mcg, followed by IGALMI 120 mcg, compared to placebo.*

FDA Label Image

Figure 2 (Igalmi 13)

A line graph depicting the change in PEC (Positive and Negative Syndrome Scale - Excited Component) score from baseline over 120 minutes post dose. The graph compares placebo with IGALMI film at 120 mcg and 180 mcg dosages, showing mean values with standard error bars for each group of 126 subjects.*

FDA Label Image

Principal Display Panel (120 mcg Film Pouch Carton)

Packaging label for IGALMI 120 mcg sublingual film containing dexmedetomidine. The box indicates 10 pouches, each containing one film, for sublingual or buccal use. The labeler is BioXcel Therapeutics, Inc. The label includes usage instructions to keep IGALMI in the pouch until administration and warns not to chew or swallow the film.*

FDA Label Image

Principal Display Panel (180 mcg Film Pouch Carton)

The packaging label for IGALMI 180 mcg sublingual film by BioXcel Therapeutics, Inc. The label features the proprietary name IGALMI with the generic name dexmedetomidine below, indicating a 180 microgram dosage strength. It includes directions to keep the film in the pouch until administration and not to chew or swallow the film. The package contains 10 pouches, each with one film. Branding elements and regulatory markings including a barcode and NDC number are visible.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.