XDEMVY

Product NDC: 81942-125
11-digit product format: 819420125
Labeler code: 81942
Product ID: 81942-125_1f574fcb-3810-2e5c-e063-6394a90aafd3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lotilaner ophthalmic solution
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Tarsus Pharmaceuticals, Inc.
Application: NDA217603
Marketing category: NDA
Marketing start: 2023-08-14
Substance: LOTILANER
Active strength: 2.5 mg/mL
Pharmacologic classes: Ectoparasiticide [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
N217603-001	XDEMVY	LOTILANER	0.25%	SOLUTION/DROPS / OPHTHALMIC		RLD, RS	2023-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23
N217603-001	10835517	2038-12-14	U-3674		2023-08-23
N217603-001	11197847	2038-12-14	U-3674		2023-08-23
N217603-001	11690826	2038-12-14	U-3674		2023-08-23
N217603-001	11690827	2038-12-14	U-3674		2023-08-23
N217603-001	11752137	2038-12-14		Drug product	2023-09-19
N217603-001	12171750	2038-12-14	U-3674		2025-01-23
N217603-001	12213964	2038-12-14		Drug product	2025-03-06
N217603-001	12364685	2038-12-14		Drug product	2025-08-07

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217603-001	NCE	2028-07-24

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217603-001	XDEMVY	0.25%	SOLUTION/DROPS / OPHTHALMIC	RLD, RS	2023-07-24	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 144 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	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11690827	2038-12-14	U-3674		2023-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	11752137	2038-12-14		Drug product	2023-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12171750	2038-12-14	U-3674		2025-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12213964	2038-12-14		Drug product	2025-03-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217603-001	12364685	2038-12-14		Drug product	2025-08-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	8383659	2030-01-17		Drug substance, Drug product	2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	10835517	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	11197847	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	11690826	2038-12-14	U-3674		2023-08-23	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N217603-001	NCE	2028-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217603-001	NCE	2028-07-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217603-001	NCE	2028-07-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217603-001	NCE	2028-07-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217603-001	NCE	2028-07-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217603-001	NCE	2028-07-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217603-001	NCE	2028-07-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217603-001	NCE	2028-07-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217603-001	NCE	2028-07-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217603-001	NCE	2028-07-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217603-001	NCE	2028-07-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217603-001	NCE	2028-07-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217603-001	NCE	2028-07-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217603-001	NCE	2028-07-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217603-001	NCE	2028-07-24	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217603-001	NCE	2028-07-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217603-001	NCE	2028-07-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217603-001	NCE	2028-07-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217603-001	NCE	2028-07-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217603-001	NCE	2028-07-24	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217603-001	NCE	2028-07-24	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: XDEMVY
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LOTILANER	2.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
HEH4938D7K	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2644507	Internal RxNorm lookup
2644512	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ccd9e37c-654e-4e84-8c85-6523457df979	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
373dd329-965c-4df5-9985-c01fbf324eac	Product name	1	20231023

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
81942-125-01	2024-08-10	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-99	2024-08-10	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-01	2024-07-30	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-99	2024-07-30	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-01	2024-01-30	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023
81942-125-99	2024-01-30	These highlights do not include all the information needed to use XDEMVY safely and effectively. See full prescribing information for XDEMVY. XDEMVY™ (lotilaner ophthalmic solution) 0.25%, for topical ophthalmic use Initial U.S. Approval: 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81942-125-01	XDEMVY	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10	3
81942-125-01	XDEMVY	1 in 1 CARTON	SOLUTION/ DROPS	1	3
81942-125-99	XDEMVY	1 in 1 CARTON	SOLUTION/ DROPS	1	3
81942-125-99	XDEMVY	1.5 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	1.5	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
81942-125-01	ML - Milliliter	81942-125	625c397d-185f-4af9-97a0-4a9be1b78eb5	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81942-125	XDEMVY (LOTILANER OPHTHALMIC SOLUTION) SOLUTION/ DROPS [TARSUS PHARMACEUTICALS, INC.]	3	Current NDC, 4 package rows	20240811_ccd9e37c-654e-4e84-8c85-6523457df979.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
XDEMVY	LOTILANER OPHTHALMIC SOLUTION	Tarsus Pharmaceuticals, Inc.	ccd9e37c-654e-4e84-8c85-6523457df979	2024-08-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217603 application number: NDA217603 ndc (product): 81942-125

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
HEH4938D7K	LOTILANER	1369852-71-0	LOTILANER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2644507	lotilaner 0.25 % Ophthalmic Solution	PSN	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644512	xdemvy 0.25 % Ophthalmic Solution	PSN	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644512	lotilaner 2.5 MG/ML Ophthalmic Solution [Xdemvy]	SBD	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644507	lotilaner 2.5 MG/ML Ophthalmic Solution	SCD	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644507	lotilaner 0.25 % Ophthalmic Solution	SY	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644512	Xdemvy 0.25 % Ophthalmic Solution	SY	ccd9e37c-654e-4e84-8c85-6523457df979	3
2644512	Xdemvy 2.5 MG/ML Ophthalmic Solution	SY	ccd9e37c-654e-4e84-8c85-6523457df979	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
81942-125-01	81942012501	1 BOTTLE, DROPPER in 1 CARTON (81942-125-01) / 10 mL in 1 BOTTLE, DROPPER	2023-08-14	No	No	Current
81942-125-99	81942012599	1 BOTTLE, DROPPER in 1 CARTON (81942-125-99) / 1.5 mL in 1 BOTTLE, DROPPER	2023-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lotilaner ophthalmic solution	Tarsus Pharmaceuticals, Inc.	2024-08-10	HUMAN PRESCRIPTION DRUG LABEL	3