Home NDC 71571-121 Inveltys
Product NDC 71571-121
11-digit product format 715710121
Labeler code 71571
Product ID 71571-121_753138b5-b236-414d-bc64-d33b52d8224f
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 2026-09-30
Substance LOTEPREDNOL ETABONATE
Active strength 10 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 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 · 42 observed 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 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…2022-10-28 04:53 UTC 2022-10 N210565-001 INVELTYS 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2018-08-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210565-001 INVELTYS 1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2018-08-22 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 12 · 480 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 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…2026-08-18 06:07:40 2026-07 N210565-001 9737491 2033-05-03 U-2492 2018-09-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N210565-001 9827191 2033-05-03 U-2493 Drug product 2018-09-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N210565-001 10058511 2033-05-03 U-2492 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 10646437 2033-05-03 Drug product 2020-06-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 10688045 2033-05-03 Drug product 2020-07-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 10864219 2033-05-03 U-3011 2020-12-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 11219597 2033-05-03 U-3278 2022-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 11219597 2033-05-03 U-3279 2022-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 11642317 2033-05-03 Drug product 2023-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 11872318 2033-05-03 Drug product 2024-02-01 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 12115246 2033-05-03 U-4025 Drug product 2024-11-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 9056057 2033-05-03 U-2491 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 9393213 2033-05-03 Drug product 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 9532955 2033-05-03 U-2491 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 9737491 2033-05-03 U-2492 2018-09-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210565-001 9827191 2033-05-03 U-2493 Drug product 2018-09-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 10058511 2033-05-03 U-2492 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 10646437 2033-05-03 Drug product 2020-06-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 10688045 2033-05-03 Drug product 2020-07-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 10864219 2033-05-03 U-3011 2020-12-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 11219597 2033-05-03 U-3278 2022-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 11219597 2033-05-03 U-3279 2022-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 11642317 2033-05-03 Drug product 2023-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 11872318 2033-05-03 Drug product 2024-02-01 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 12115246 2033-05-03 U-4025 Drug product 2024-11-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 9056057 2033-05-03 U-2491 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 9393213 2033-05-03 Drug product 2018-09-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210565-001 9532955 2033-05-03 U-2491 2018-09-10 31067a03dcf5…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base Inveltys Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YEH1EZ96K6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2055281 Internal RxNorm lookup 2055286 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength 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 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 Current NDC, Legacy NDC, 3 package rows 20240402_2ec16df8-2e5c-4e06-8d28-21df76f27d72.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 · 2 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 71571-121-20 71571012120 2.8 mL in 1 BOTTLE, DROPPER (71571-121-20) 2.8 ml 2018-08-22 0000-00-00 Yes No Current 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