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 ID: 81092-1180_2feb689e-7fb4-4865-b6e5-1b5193de2fba
• NDC: 81092-1180
• Product Type: Human Prescription Drug
• Proprietary Name: IGALMI
• Generic Name: Dexmedetomidine
• Dosage Form: Film
• Route of Administration: SUBLINGUAL
• Marketing Start Date: 2022-07-01
• Marketing Category: NDA /
• Application Number: NDA215390
• Labeler Name: BioXcel Therapeutics, Inc.
• Substance Name: DEXMEDETOMIDINE
• Active Ingredient Strength: 180 ug/1
• Pharm Classes: Adrenergic alpha2-Agonists [MoA], Central alpha-2 Adrenergic Agonist [EPC], General Anesthesia [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 81092-1180-1

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

• Marketing Start Date: 2022-07-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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

NDC	Brand Name	Generic Name
81092-1120	IGALMI	DEXMEDETOMIDINE
81092-1180	IGALMI	DEXMEDETOMIDINE
16729-239	Dexmedetomidine	Dexmedetomidine
16729-432	DEXMEDETOMIDINE	DEXMEDETOMIDINE
55150-209	Dexmedetomidine	Dexmedetomidine
57884-3091	DEXMEDETOMIDINE	DEXMEDETOMIDINE
66794-230	Dexmedetomidine	Dexmedetomidine
66794-233	Dexmedetomidine	Dexmedetomidine
66794-238	Dexmedetomidine	Dexmedetomidine
67457-251	Dexmedetomidine	dexmedetomidine
70860-605	Dexmedetomidine	dexmedetomidine
71288-505	DEXMEDETOMIDINE	DEXMEDETOMIDINE
71872-7150	Dexmedetomidine	dexmedetomidine