What is NDC 16110-391?

16110-391 is the product NDC for Klisyri (tirbanibulin), Tirbanibulin 10 mg/g ointment, listed with the FDA by Almirall, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Almirall, LLC, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Klisyri?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Klisyri NDC 16110-391 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16110-391Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16110-0391Add 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
16110-391-05	16110039105	5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKETMarketed from Dec 14, 2020
16110-391-55	16110039155	5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKETMarketed from Jun 7, 2024

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Klisyri
Generic name (nonproprietary): tirbanibulin
Active ingredients: Tirbanibulin — 10 mg/g
Dosage form: Ointment
Route: Topical
Labeler: Almirall, LLCNDC labeler code 16110
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213189
Marketing start: Dec 14, 2020
Listing expires: Dec 31, 2027
Other FDA classes: Microtubule Inhibition (Physiologic effect)
Identifiers: Product ID 16110-391_f94fb2ea-6246-4279-8819-f9b6d038e47cSPL ID f94fb2ea-6246-4279-8819-f9b6d038e47cSPL set ID 589c8de8-b773-4d47-b60c-48471806ccccRxCUI 2471095, 2471100UNII 4V9848RS5GUPC 0316110391052, 0316110391557
Pharmacologic class: Microtubule Inhibitor

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N416110039105 followed by a unit qualifier and the quantity

Package 16110-0391-05. 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

Current FDA label (SPL), effective Jun 24, 2026.

Indications (excerpt from the label)

KLISYRI is indicated for the topical field treatment of actinic keratosis on the face or scalp. KLISYRI is a microtubule inhibitor indicated for the topical treatment of actinic keratosis of the face or scalp. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16110-391

What is NDC 16110-391?: 16110-391 is the product NDC for Klisyri (tirbanibulin), Tirbanibulin 10 mg/g ointment, listed with the FDA by Almirall, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Klisyri (Tirbanibulin).
What is the active ingredient?: Tirbanibulin.
Who is the labeler?: Almirall, LLC, NDC labeler code 16110. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Klisyri?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Klisyri (Tirbanibulin) NDC 16110-391