Home NDC 16110-391 Klisyri
Product NDC 16110-391
11-digit product format 161100391
Labeler code 16110
Product ID 16110-391_89dd936d-4a69-4c60-b743-dfefb589ec1a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tirbanibulin
Dosage form OINTMENT
Route TOPICAL
Labeler Almirall, LLC
Application NDA213189
Marketing category NDA
Marketing start 2020-12-14
Substance TIRBANIBULIN
Active strength 10 mg/g
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213189-001 KLISYRI TIRBANIBULIN 1% OINTMENT / TOPICAL RLD, RS 2020-12-14
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213189-001 10323001 2027-12-28 Drug product 2021-01-12 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 N213189-001 7300931 2030-12-28 Drug substance, Drug product 2021-01-12 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 N213189-001 12667576 2038-03-12 U-4577 2026-07-22 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213189-001 D-192 2027-06-07
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213189-001 KLISYRI 1% OINTMENT / TOPICAL RLD, RS 2020-12-14 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 272 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N213189-001 10323001 2027-12-28 Drug product 2021-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 7300931 2030-12-28 Drug substance, Drug product 2021-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 12667576 2038-03-12 U-4577 2026-07-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213189-001 10323001 2027-12-28 Drug product 2021-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213189-001 7300931 2030-12-28 Drug substance, Drug product 2021-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 8236799 2025-12-28 Drug substance, Drug product 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 8980890 2025-12-28 Drug substance, Drug product 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 10323001 2027-12-28 Drug product 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 7300931 2030-12-28 Drug substance, Drug product 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213189-001 8236799 2025-12-28 Drug substance, Drug product 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 8980890 2025-12-28 Drug substance, Drug product 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 7300931 2026-02-06 Drug substance, Drug product 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 10323001 2027-12-28 Drug product 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 8236799 2025-12-28 Drug substance, Drug product 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 8980890 2025-12-28 Drug substance, Drug product 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 7300931 2026-02-06 Drug substance, Drug product 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 10323001 2027-12-28 Drug product 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 7851470 2029-02-02 U-3015 Drug substance, Drug product 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 10617693 2038-03-12 U-3015 2021-01-12 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 11497750 2038-03-12 U-3015 2022-12-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213189-001 10669236 2038-09-07 Drug substance, Drug product 2021-01-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213189-001 8236799 2025-12-28 Drug substance, Drug product 2021-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213189-001 8980890 2025-12-28 Drug substance, Drug product 2021-01-12 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213189-001 7300931 2026-02-06 Drug substance, Drug product 2021-01-12 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 46 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Klisyri
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TIRBANIBULIN 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4V9848RS5G Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2471095 Internal RxNorm lookup 2471100 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 16110-391-05 Klisyri 0.25 g in 1 PACKET OINTMENT 0.25 12 16110-391-05 Klisyri 5 in 1 CARTON OINTMENT 5 12 16110-391-55 Klisyri 0.35 g in 1 PACKET OINTMENT 0.35 12 16110-391-55 Klisyri 5 in 1 CARTON OINTMENT 5 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16110-391 KLISYRI (TIRBANIBULIN) OINTMENT [ALMIRALL, LLC] 12 Current NDC, Legacy NDC, 4 package rows 20241109_589c8de8-b773-4d47-b60c-48471806cccc.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 16110-391-05 16110039105 5 PACKET in 1 CARTON (16110-391-05) / .25 g in 1 PACKET 5 packet 2020-12-14 0000-00-00 No No Current 16110-391-55 16110039155 5 PACKET in 1 CARTON (16110-391-55) / .35 g in 1 PACKET 5 packet 2024-06-07 No No Current