NDC 81092-1180

IGALMI

Dexmedetomidine

IGALMI is a Sublingual Film in the Human Prescription Drug category. It is labeled and distributed by Bioxcel Therapeutics, Inc.. The primary component is Dexmedetomidine.

Product ID81092-1180_2feb689e-7fb4-4865-b6e5-1b5193de2fba
NDC81092-1180
Product TypeHuman Prescription Drug
Proprietary NameIGALMI
Generic NameDexmedetomidine
Dosage FormFilm
Route of AdministrationSUBLINGUAL
Marketing Start Date2022-07-01
Marketing CategoryNDA /
Application NumberNDA215390
Labeler NameBioXcel Therapeutics, Inc.
Substance NameDEXMEDETOMIDINE
Active Ingredient Strength180 ug/1
Pharm ClassesAdrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 81092-1180-1

10 POUCH in 1 CARTON (81092-1180-1) > 1 FILM in 1 POUCH (81092-1180-0)
Marketing Start Date2022-07-01
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "IGALMI" or generic name "Dexmedetomidine"

NDCBrand NameGeneric Name
81092-1120IGALMIDEXMEDETOMIDINE
81092-1180IGALMIDEXMEDETOMIDINE
16729-239DexmedetomidineDexmedetomidine
16729-432DEXMEDETOMIDINEDEXMEDETOMIDINE
55150-209DexmedetomidineDexmedetomidine
57884-3091DEXMEDETOMIDINEDEXMEDETOMIDINE
66794-230DexmedetomidineDexmedetomidine
66794-233DexmedetomidineDexmedetomidine
66794-238DexmedetomidineDexmedetomidine
67457-251Dexmedetomidinedexmedetomidine
70860-605Dexmedetomidinedexmedetomidine
71288-505DEXMEDETOMIDINEDEXMEDETOMIDINE
71872-7150Dexmedetomidinedexmedetomidine

Trademark Results [IGALMI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
IGALMI
IGALMI
98620766 not registered Live/Pending
BioXcel Therapeutics, Inc.
2024-06-26
IGALMI
IGALMI
90295383 not registered Live/Pending
Bioxcel Therapeutics, Inc.
2020-11-03

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