Igalmi (dexmedetomidine) NDC 81092-1180

NDC codes

FDA NDC Directory

Product NDC (as listed)81092-1180Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81092-1180Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
81092-1180-1	81092118001	10 POUCH in 1 CARTON (81092-1180-1) / 1 FILM in 1 POUCH (81092-1180-0)Marketed from Jul 1, 2022
81092-1180-3	81092118003	30 POUCH in 1 CARTON (81092-1180-3) / 1 FILM in 1 POUCH (81092-1180-0)Marketed from Jul 1, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Igalmi
Generic name (nonproprietary): dexmedetomidine
Active ingredients: Dexmedetomidine — 180 ug/1
Dosage form: Film
Route: Sublingual
Labeler: BioXcel Therapeutics, Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215390
Marketing start: Jul 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
Identifiers: Product ID 81092-1180_56208dd8-92d8-419a-995b-27b1c1513329SPL ID 56208dd8-92d8-419a-995b-27b1c1513329
Pharmacologic class: Central alpha-2 Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Sublingual products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N481092118001 followed by a unit qualifier and the quantity

Package 81092-1180-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under NDA 215390

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 215390
Product	Strength	Form · route	Labeler	Product NDC
Igalmidexmedetomidine	Dexmedetomidine 120 ug/1	FilmSublingual	BioXcel Therapeutics, Inc.	81092-1120