Inveltys

Product NDC: 71571-121
Requested package NDC: 71571-121-28
11-digit product format: 715710121
Labeler code: 71571
Product ID: 71571-121_01fd574e-d995-49be-9094-ab0ae3318703
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loteprednol etabonate
Dosage form: SUSPENSION
Route: TOPICAL
Labeler: ALCON LABORATORIES, INC.
Application: NDA210565
Marketing category: NDA
Marketing start: 2018-08-22
Marketing end: 0000-00-00
Substance: LOTEPREDNOL ETABONATE
Active strength: 10 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71571-121	71571-121-28	D	Discontinued by firm		2026-10-30

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N210565-001	INVELTYS	LOTEPREDNOL ETABONATE	1%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2018-08-22

Orange Book patents#

Current patent rows page 1 of 1 · 14 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10
N210565-001	10646437	2033-05-03		Drug product	2020-06-11
N210565-001	10688045	2033-05-03		Drug product	2020-07-16
N210565-001	10864219	2033-05-03	U-3011		2020-12-28
N210565-001	11219597	2033-05-03	U-3278		2022-01-21
N210565-001	11219597	2033-05-03	U-3279		2022-01-21
N210565-001	11642317	2033-05-03		Drug product	2023-05-31
N210565-001	11872318	2033-05-03		Drug product	2024-02-01
N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08
N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10
N210565-001	9393213	2033-05-03		Drug product	2018-09-10
N210565-001	9532955	2033-05-03	U-2491		2018-09-10
N210565-001	9737491	2033-05-03	U-2492		2018-09-10
N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10

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.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210565-001	INVELTYS	1%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2018-08-22	`3a93d1ddd44b…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 508 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9737491	2033-05-03	U-2492		2018-09-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9737491	2033-05-03	U-2492		2018-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210565-001	9827191	2033-05-03	U-2493	Drug product	2018-09-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210565-001	10058511	2033-05-03	U-2492	Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10646437	2033-05-03		Drug product	2020-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10688045	2033-05-03		Drug product	2020-07-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	10864219	2033-05-03	U-3011		2020-12-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11219597	2033-05-03	U-3278		2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11219597	2033-05-03	U-3279		2022-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11642317	2033-05-03		Drug product	2023-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	11872318	2033-05-03		Drug product	2024-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	12115246	2033-05-03	U-4025	Drug product	2024-11-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9056057	2033-05-03	U-2491	Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9393213	2033-05-03		Drug product	2018-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210565-001	9532955	2033-05-03	U-2491		2018-09-10	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N210565-001	NP	2021-08-22	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210565-001	NP	2021-08-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210565-001	NP	2021-08-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210565-001	NP	2021-08-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210565-001	NP	2021-08-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210565-001	NP	2021-08-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210565-001	NP	2021-08-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210565-001	NP	2021-08-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210565-001	NP	2021-08-22	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f474382-f6ee-e00d-5df3-bba50cddfd89	Product name	5	20251114
64ba4d79-5363-eefc-3390-ee5d2a50a350	Product name	3	20250304
100e83dc-ec8c-9e2e-76d2-5112415ec972	Product name	3	20241008
4300453c-d545-46d1-b115-18b12b4ccf79	Product name	1	20210525
3f316f1c-2561-47c9-9865-ba2be69e0b3e	Product name	1	20190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35	Product name	1	20181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b5c5cd73-a27b-5e41-bd36-3de9471473cd	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71571-121-20	Inveltys	2.8 mL in 1 BOTTLE, DROPPER	SUSPENSION	2.8	10
71571-121-28	Inveltys	1 in 1 CARTON	SUSPENSION	1	10
71571-121-28	Inveltys	2.8 mL in 1 BOTTLE, DROPPER	SUSPENSION	2.8	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71571-121-28	ML - Milliliter	71571-121	23ea90ab-6ed1-4ecf-b836-e17284540400	1	2018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71571-121	INVELTYS (LOTEPREDNOL ETABONATE) SUSPENSION [ALCON LABORATORIES, INC.]	10	Legacy NDC, 3 package rows	20240402_2ec16df8-2e5c-4e06-8d28-21df76f27d72.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YEH1EZ96K6	LOTEPREDNOL ETABONATE	82034-46-6	LOTEPREDNOL ETABONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2055286	INVELTYS 1 % Ophthalmic Suspension	PSN	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055281	loteprednol etabonate 1 % Ophthalmic Suspension	PSN	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055286	loteprednol etabonate 10 MG/ML Ophthalmic Suspension [Inveltys]	SBD	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055281	loteprednol etabonate 10 MG/ML Ophthalmic Suspension	SCD	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055286	Inveltys 1 % Ophthalmic Suspension	SY	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055286	Inveltys 10 MG/ML Ophthalmic Suspension	SY	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10
2055281	loteprednol etabonate 1 % Ophthalmic Suspension	SY	2ec16df8-2e5c-4e06-8d28-21df76f27d72	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71571-121-28	71571012128	1 BOTTLE, DROPPER in 1 CARTON (71571-121-28) > 2.8 mL in 1 BOTTLE, DROPPER	2018-08-22	0000-00-00	No	No	Current