FDA.reportPublic FDA data

IGALMI

Product NDC
81092-1120
11-digit product format
810921120
Labeler code
81092
Product ID
81092-1120_56208dd8-92d8-419a-995b-27b1c1513329
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DEXMEDETOMIDINE
Dosage form
FILM
Route
SUBLINGUAL
Labeler
BioXcel Therapeutics, Inc.
Application
NDA215390
Marketing category
NDA
Marketing start
2022-07-01
Substance
DEXMEDETOMIDINE
Active strength
120 ug/1
Pharmacologic classes
Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
IGALMI
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXMEDETOMIDINE120 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ec136f1-cd53-4b90-826e-3eaeec54dca0Product name220250401
acae4bed-c293-9f7e-61b9-d68b8475ed3aProduct name220230104
536fa340-f745-6c4e-1ad7-a3c414722bccProduct name920170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81092-1120-0IGALMI1 in 1 POUCHFILM14
81092-1120-1IGALMI10 in 1 CARTONFILM104
81092-1120-3IGALMI30 in 1 CARTONFILM304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81092-1120-0EA - Each81092-1120239481b0-212f-4c20-8e8b-d8d3ba59d6d212024-08-12
81092-1120-1EA - Each81092-1120774cb08a-d423-4baa-8f9e-ebdf02dd1f3412022-06-06
81092-1120-3EA - Each81092-11208543f013-375c-46e3-97df-34fd331ff36212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81092-1120IGALMI (DEXMEDETOMIDINE) FILM [BIOXCEL THERAPEUTICS, INC.]3Current NDC, Legacy NDC, 3 package rows20221217_99476e8c-2527-4cb0-9d67-9f9cd91343c6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2601119dexmedeTOMIDine 120 MCG Sublingual FilmPSN99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601129dexmedeTOMIDine 180 MCG Sublingual FilmPSN99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601126Igalmi 120 MCG Sublingual FilmPSN99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601131Igalmi 180 MCG Sublingual FilmPSN99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601126dexmedetomidine 0.12 MG Sublingual Film [Igalmi]SBD99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601131dexmedetomidine 0.18 MG Sublingual Film [Igalmi]SBD99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601119dexmedetomidine 0.12 MG Sublingual FilmSCD99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601129dexmedetomidine 0.18 MG Sublingual FilmSCD99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601119dexmedetomidine 120 MCG (as dexmedetomidine hydrochloride 141.8 MCG) Sublingual FilmSY99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601129dexmedetomidine 180 MCG (as dexmedetomidine hydrochloride 212.7 MCG) Sublingual FilmSY99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601126Igalmi 120 MCG (as dexmedetomidine hydrochloride 141.8 MCG) Sublingual FilmSY99476e8c-2527-4cb0-9d67-9f9cd91343c64
2601131Igalmi 180 MCG (as dexmedetomidine hydrochloride 212.7 MCG) Sublingual FilmSY99476e8c-2527-4cb0-9d67-9f9cd91343c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81092-1120-0810921120001 in 1 POUCHHistorical
81092-1120-18109211200110 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) 10 pouch2022-07-010000-00-00NoNoCurrent
81092-1120-38109211200330 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0) 30 pouch2024-07-010000-00-00NoNoCurrent