igalmi

Generic: dexmedetomidine

Labeler: bioxcel therapeutics, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name igalmi
Generic Name dexmedetomidine
Labeler bioxcel therapeutics, inc.
Dosage Form FILM
Routes
SUBLINGUAL
Active Ingredients

dexmedetomidine 120 ug/1

Manufacturer
BioXcel Therapeutics, Inc.

Identifiers & Regulatory

Product NDC 81092-1120
Product ID 81092-1120_33fc5c5f-c14d-4e5b-8031-095b72b9c8bb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA215390
Listing Expiration 2026-12-31
Marketing Start 2022-07-01

Pharmacologic Class

Established (EPC)
central alpha-2 adrenergic agonist [epc]
Mechanism of Action
adrenergic alpha2-agonists [moa]
Physiologic Effect
general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 810921120
Hyphenated Format 81092-1120

Supplemental Identifiers

RxCUI
2601119 2601126 2601129 2601131
UNII
67VB76HONO
NUI
N0000009918 N0000175554 N0000175975

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name igalmi (source: ndc)
Generic Name dexmedetomidine (source: ndc)
Application Number NDA215390 (source: ndc)
Routes
SUBLINGUAL
source: ndc

Resolved Composition

Strengths
  • 120 ug/1
source: ndc
Packaging
  • 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)
  • 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)
source: ndc

Packages (2)

81092-1120-1 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0) 81092-1120-3 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)

Ingredients (1)

dexmedetomidine (120 ug/1)

Linked Drug Pages (1)

IGALMI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBLINGUAL"], "spl_id": "33fc5c5f-c14d-4e5b-8031-095b72b9c8bb", "openfda": {"nui": ["N0000009918", "N0000175554", "N0000175975"], "unii": ["67VB76HONO"], "rxcui": ["2601119", "2601126", "2601129", "2601131"], "spl_set_id": ["99476e8c-2527-4cb0-9d67-9f9cd91343c6"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["Central alpha-2 Adrenergic Agonist [EPC]"], "pharm_class_moa": ["Adrenergic alpha2-Agonists [MoA]"], "manufacturer_name": ["BioXcel Therapeutics, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 POUCH in 1 CARTON (81092-1120-1)  / 1 FILM in 1 POUCH (81092-1120-0)", "package_ndc": "81092-1120-1", "marketing_start_date": "20220701"}, {"sample": false, "description": "30 POUCH in 1 CARTON (81092-1120-3)  / 1 FILM in 1 POUCH (81092-1120-0)", "package_ndc": "81092-1120-3", "marketing_start_date": "20240701"}], "brand_name": "IGALMI", "product_id": "81092-1120_33fc5c5f-c14d-4e5b-8031-095b72b9c8bb", "dosage_form": "FILM", "pharm_class": ["Adrenergic alpha2-Agonists [MoA]", "Central alpha-2 Adrenergic Agonist [EPC]", "General Anesthesia [PE]"], "product_ndc": "81092-1120", "generic_name": "DEXMEDETOMIDINE", "labeler_name": "BioXcel Therapeutics, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IGALMI", "active_ingredients": [{"name": "DEXMEDETOMIDINE", "strength": "120 ug/1"}], "application_number": "NDA215390", "marketing_category": "NDA", "marketing_start_date": "20220701", "listing_expiration_date": "20261231"}