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United States · US · US:81092-1180_56208dd8-92d8-419a-995b-27b1c1513329
IGALMI
In shortageOrange BookUNIISPLATC N05CM18
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBioXcel Therapeutics, Inc.
CountryUS (United States)
ATC codeN05CM18
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc11810921180110 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0)
- ndc11810921180330 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0)
Annotations
UNII (FDA Substance ID)
67VB76HONO
DEXMEDETOMIDINE
RxCUI 48937
Orange Book
N215390
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dexmedetomidine Hydrochloride Injection
Raw payload (JSON)
{
"unii": {
"unii": "67VB76HONO",
"rxcui": "48937",
"inchikey": "CUHVIMMYOGQXCV-NSHDSACASA-N",
"display_name": "DEXMEDETOMIDINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBLINGUAL",
"spl_meta": {
"99476e8c-2527-4cb0-9d67-9f9cd91343c6": {
"match": "brand_token",
"title": "IGALMI (DEXMEDETOMIDINE) FILM [BIOXCEL THERAPEUTICS, INC.]",
"spl_version": "4",
"published_date": "2025-11-26"
}
},
"productid": "81092-1180_56208dd8-92d8-419a-995b-27b1c1513329",
"productndc": "81092-1180",
"dosage_form": "FILM",
"orange_book": {
"appl_no": "215390",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.12MG BASE",
"product_no": "001",
"approval_date": "Apr 5, 2022"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 0.18MG BASE",
"product_no": "002",
"approval_date": "Apr 5, 2022"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXMEDETOMIDINE",
"shortage_reason": "Dexmedetomidine Hydrochloride Injection",
"shortage_status": "current",
"proprietary_name": "IGALMI",
"active_ingred_unit": "ug/1",
"application_number": "NDA215390",
"marketing_category": "NDA",
"nonproprietary_name": "DEXMEDETOMIDINE",
"start_marketing_date": "20220701",
"active_numerator_strength": "180"
}Related drugs
Other records sharing ATC code N05CM18.
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