Prescription drug · NDA
Igalmi (Dexmedetomidine) NDC 81092-1120
Dexmedetomidine 120 ug/1 · Film · Sublingual · BioXcel Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81092-1120-1 | 8109211200181092112001 | 10 POUCH in 1 CARTON (81092-1120-1) / 1 FILM in 1 POUCH (81092-1120-0)Marketed from Jul 1, 2022 | |
| 81092-1120-3 | 8109211200381092112003 | 30 POUCH in 1 CARTON (81092-1120-3) / 1 FILM in 1 POUCH (81092-1120-0)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 — 120 ug/1
- Dosage form
- Film
- Route
- Sublingual
- Labeler
- BioXcel Therapeutics, Inc.NDC labeler code 81092
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215390
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha2-Agonists (Mechanism)General Anesthesia (Physiologic effect)
- Identifiers
- Product ID 81092-1120_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
N481092112001followed by a unit qualifier and the quantityPackage 81092-1120-01. 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.
About NDC 81092-1120
- What is NDC 81092-1120?
- 81092-1120 is the product NDC for Igalmi (dexmedetomidine), Dexmedetomidine 120 ug/1 film, listed with the FDA by BioXcel Therapeutics, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Igalmi (Dexmedetomidine).
- What is the active ingredient?
- Dexmedetomidine.
- Who is the labeler?
- BioXcel Therapeutics, Inc., NDC labeler code 81092. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Igalmi?
- 1 other product NDC are listed under this name. See all Igalmi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Igalmi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Igalmidexmedetomidine | Dexmedetomidine 180 ug/1 | FilmSublingual | BioXcel Therapeutics, Inc. | 81092-1180 | 81092-1180-0181092-1180-03 |
Other NDCs under NDA 215390
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Igalmidexmedetomidine | Dexmedetomidine 180 ug/1 | FilmSublingual | BioXcel Therapeutics, Inc. | 81092-1180 |