Package 81092-1120-1
Brand: igalmi
Generic: dexmedetomidinePackage Facts
Identity
Package NDC
81092-1120-1
Digits Only
8109211201
Product NDC
81092-1120
Description
10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)
Marketing
Marketing Status
Brand
igalmi
Generic
dexmedetomidine
Sample Package
No
Linked Drug Pages (1)
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"}