Igalmi Film
Product Images NDC 81092-1180

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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)

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Figure (Igalmi 02)

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Figure (Igalmi 03)

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Figure (Igalmi 04)

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Figure (Igalmi 05)

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Figure (Igalmi 06)

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Figure (Igalmi 07)

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Figure (Igalmi 08)

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Figure (Igalmi 09)

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Figure (Igalmi 10)

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Chemical Structure (Igalmi 11)

FDA Label Image

Figure 1 (Igalmi 12)

Figure 1 (Igalmi 12)
This text presents the change in PEC score from baseline for three groups (placebo, IGALMI 120 mcg, IGALMI 180 mcg) over time post-dose in minutes. The PEC score is related to the Positive and Negative Syndrome Scale - Excited Component. Standard error values are also given. The baseline PEC scores were 17.6, 17.5, and 17.6 for the placebo, IGALMI 120 mcg, and IGALMI 180 mcg groups, respectively.*
FDA Label Image

Figure 2 (Igalmi 13)

Figure 2 (Igalmi 13)
This is a description of a study or experiment that measured the change in PEC score from baseline in three groups of participants (placebo, IGALMI 120 mcg, and IGALMI 180 mcg), over time post dose (in minutes). The PEC score is a measure of the Positive and Negative Syndrome Scale - Excited Component. The baseline PEC scores for each group are also provided.*
FDA Label Image

Principal Display Panel (120 mcg Film Pouch Carton)

Principal Display Panel (120 mcg Film Pouch Carton)
This is a description of a sublingual film medication called "Igalm" from BioXcel Therapeutics Inc. It is a dexmedetomidine drug and is manufactured in the USA. It comes in 10 pouches, and each pouch contains one film. The administration method for the medication is sublingual or buccal, and the film should not be chewed or swallowed. The medication details include Lot NNNNNNN, EXP YYYY-NMH-DD, and GTIN XXXXXXXXXXXXXX, and 125738 SN XXXXXXXX. The rest of the text is not related to the medication description.*
FDA Label Image

Principal Display Panel (180 mcg Film Pouch Carton)

Principal Display Panel (180 mcg Film Pouch Carton)
This is a medication for sublingual or buccal use named IGALMI (dexmedetomidine) and it comes in 10 pouches where each pouch contains a film. The medication must not be chewed or swallowed and should be kept in the pouch until administration. The available NDC number is 8109211801.*

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.