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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N215390-001	IGALMI	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL		RLD, RS	2022-04-05
N215390-002	IGALMI	DEXMEDETOMIDINE HYDROCHLORIDE	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL		RLD	2022-04-05

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215390-001	11786508	2037-12-29	U-3698		2023-10-17
N215390-001	11839604	2037-12-29	U-3756		2023-12-12
N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28
N215390-001	11478422	2039-06-26		Drug product	2022-11-22
N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15
N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06
N215390-001	11890272	2040-07-17	U-3756		2024-02-06
N215390-001	11890272	2040-07-17	U-3935		2024-02-06
N215390-001	11998529	2040-07-17	U-3935		2024-06-05
N215390-001	12109196	2040-07-17	U-3935		2024-10-11
N215390-001	11806334	2043-01-12	U-3725		2023-11-07
N215390-001	11998528	2043-01-12	U-3935		2024-06-20
N215390-001	12090140	2043-01-12	U-3986		2024-09-18
N215390-001	12138247	2043-01-12	U-4029		2024-11-13
N215390-001	12364683	2043-01-12	U-4029		2025-08-21
N215390-002	11786508	2037-12-29	U-3698		2023-10-17
N215390-002	11839604	2037-12-29	U-3756		2023-12-12
N215390-002	10792246	2039-06-26	U-3350	Drug product	2022-04-28
N215390-002	11478422	2039-06-26		Drug product	2022-11-22
N215390-002	11497711	2039-06-26	U-3645	Drug product	2022-11-15
N215390-002	11517524	2039-06-26	U-3645	Drug product	2022-12-06
N215390-002	11890272	2040-07-17	U-3756		2024-02-06
N215390-002	11890272	2040-07-17	U-3935		2024-02-06
N215390-002	11998529	2040-07-17	U-3935		2024-06-05
N215390-002	12109196	2040-07-17	U-3935		2024-10-11
N215390-002	11806334	2043-01-12	U-3725		2023-11-07
N215390-002	11998528	2043-01-12	U-3935		2024-06-20
N215390-002	12090140	2043-01-12	U-3986		2024-09-18
N215390-002	12138247	2043-01-12	U-4029		2024-11-13
N215390-002	12364683	2043-01-12	U-4029		2025-08-21

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215390-001	M-82	2028-11-19
N215390-002	M-82	2028-11-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD	2022-04-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-001	IGALMI	EQ 0.12MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-002	IGALMI	EQ 0.18MG BASE	FILM / BUCCAL, SUBLINGUAL	RLD, RS	2022-04-05	`9b2671bbb829…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 484 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215390-001	11786508	2037-12-29	U-3698		2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11839604	2037-12-29	U-3756		2023-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11478422	2039-06-26		Drug product	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11890272	2040-07-17	U-3935		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11890272	2040-07-17	U-3756		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11998529	2040-07-17	U-3935		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12109196	2040-07-17	U-3935		2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11806334	2043-01-12	U-3725		2023-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	11998528	2043-01-12	U-3935		2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12090140	2043-01-12	U-3986		2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12138247	2043-01-12	U-4029		2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-001	12364683	2043-01-12	U-4029		2025-08-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11786508	2037-12-29	U-3698		2023-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11839604	2037-12-29	U-3756		2023-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11478422	2039-06-26		Drug product	2022-11-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11890272	2040-07-17	U-3935		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11890272	2040-07-17	U-3756		2024-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11998529	2040-07-17	U-3935		2024-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12109196	2040-07-17	U-3935		2024-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11806334	2043-01-12	U-3725		2023-11-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	11998528	2043-01-12	U-3935		2024-06-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12090140	2043-01-12	U-3986		2024-09-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12138247	2043-01-12	U-4029		2024-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	12364683	2043-01-12	U-4029		2025-08-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11786508	2037-12-29	U-3698		2023-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11839604	2037-12-29	U-3756		2023-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	10792246	2039-06-26	U-3350	Drug product	2022-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11478422	2039-06-26		Drug product	2022-11-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11497711	2039-06-26	U-3645	Drug product	2022-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11517524	2039-06-26	U-3645	Drug product	2022-12-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11890272	2040-07-17	U-3935		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11890272	2040-07-17	U-3756		2024-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	11998529	2040-07-17	U-3935		2024-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	12109196	2040-07-17	U-3935		2024-10-11	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215390-001	M-82	2028-11-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215390-002	M-82	2028-11-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-001	NP	2025-04-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215390-002	NP	2025-04-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215390-001	NP	2025-04-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215390-002	NP	2025-04-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-001	NP	2025-04-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215390-002	NP	2025-04-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-001	NP	2025-04-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215390-002	NP	2025-04-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-001	NP	2025-04-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215390-002	NP	2025-04-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-001	NP	2025-04-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215390-002	NP	2025-04-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-001	NP	2025-04-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215390-002	NP	2025-04-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-001	NP	2025-04-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215390-002	NP	2025-04-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215390-001	NP	2025-04-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215390-002	NP	2025-04-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-001	NP	2025-04-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215390-002	NP	2025-04-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-001	NP	2025-04-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215390-002	NP	2025-04-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-001	NP	2025-04-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215390-002	NP	2025-04-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215390-001	NP	2025-04-05	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N215390-002	NP	2025-04-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-001	NP	2025-04-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N215390-002	NP	2025-04-05	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-001	NP	2025-04-05	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215390-002	NP	2025-04-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215390-001	NP	2025-04-05	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N215390-002	NP	2025-04-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215390-001	NP	2025-04-05	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N215390-002	NP	2025-04-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-001	NP	2025-04-05	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215390-002	NP	2025-04-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-001	NP	2025-04-05	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215390-002	NP	2025-04-05	`9b2671bbb829…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXMEDETOMIDINE	120 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4ec136f1-cd53-4b90-826e-3eaeec54dca0	Product name	2	20250401
acae4bed-c293-9f7e-61b9-d68b8475ed3a	Product name	2	20230104
536fa340-f745-6c4e-1ad7-a3c414722bcc	Product name	9	20170706

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81092-1120-0	IGALMI	1 in 1 POUCH	FILM	1	4
81092-1120-1	IGALMI	10 in 1 CARTON	FILM	10	4
81092-1120-3	IGALMI	30 in 1 CARTON	FILM	30	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81092-1120-0	EA - Each	81092-1120	239481b0-212f-4c20-8e8b-d8d3ba59d6d2	1	2024-08-12
81092-1120-1	EA - Each	81092-1120	774cb08a-d423-4baa-8f9e-ebdf02dd1f34	1	2022-06-06
81092-1120-3	EA - Each	81092-1120	8543f013-375c-46e3-97df-34fd331ff362	1	2022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81092-1120	IGALMI (DEXMEDETOMIDINE) FILM [BIOXCEL THERAPEUTICS, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20221217_99476e8c-2527-4cb0-9d67-9f9cd91343c6.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
67VB76HONO	DEXMEDETOMIDINE	113775-47-6	DEXMEDETOMIDINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2601119	dexmedeTOMIDine 120 MCG Sublingual Film	PSN	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601129	dexmedeTOMIDine 180 MCG Sublingual Film	PSN	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601126	Igalmi 120 MCG Sublingual Film	PSN	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601131	Igalmi 180 MCG Sublingual Film	PSN	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601126	dexmedetomidine 0.12 MG Sublingual Film [Igalmi]	SBD	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601131	dexmedetomidine 0.18 MG Sublingual Film [Igalmi]	SBD	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601119	dexmedetomidine 0.12 MG Sublingual Film	SCD	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601129	dexmedetomidine 0.18 MG Sublingual Film	SCD	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601119	dexmedetomidine 120 MCG (as dexmedetomidine hydrochloride 141.8 MCG) Sublingual Film	SY	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601129	dexmedetomidine 180 MCG (as dexmedetomidine hydrochloride 212.7 MCG) Sublingual Film	SY	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601126	Igalmi 120 MCG (as dexmedetomidine hydrochloride 141.8 MCG) Sublingual Film	SY	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4
2601131	Igalmi 180 MCG (as dexmedetomidine hydrochloride 212.7 MCG) Sublingual Film	SY	99476e8c-2527-4cb0-9d67-9f9cd91343c6	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81092-1120-0	81092112000	1 in 1 POUCH						Historical
81092-1120-1	81092112001	10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)	10 pouch	2022-07-01	0000-00-00	No	No	Current
81092-1120-3	81092112003	30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)	30 pouch	2024-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
IGALMI - BioXcel Therapeutics, Inc. \| Arx, LLC	BioXcel Therapeutics, Inc. \| Arx, LLC	2025-11-25	HUMAN PRESCRIPTION DRUG LABEL	4