Home NDC 0065-1750-14 ILEVRO
Product NDC 0065-1750
Requested package NDC 0065-1750-14
11-digit product format 000651750
Labeler code 0065
Product ID 0065-1750_36ff7e36-d529-4e61-ac2e-2e43d37629d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nepafenac
Dosage form SUSPENSION
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
Application NDA203491
Marketing category NDA
Marketing start 2012-12-20
Marketing end 2021-11-30
Substance NEPAFENAC
Active strength 3 mg/mL
Pharmacologic classes Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N203491-001 ILEVRO NEPAFENAC 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N203491-001 9662398 2030-12-01 Drug product 2017-06-02 N203491-001 8921337 2032-03-31 Drug product 2015-06-08
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203491-001 ILEVRO 0.3% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2012-10-16 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 117 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203491-001 7947295 2024-06-08 Drug product 2013-02-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203491-001 9662398 2030-12-01 Drug product 2017-06-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203491-001 8921337 2032-03-31 Drug product 2015-06-08 5c6f7cd8ea54…
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Nepafenac ACTIVE INGREDIENT 0J9L7J6V8C ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Nepafenac ACTIVE MOIETY 0J9L7J6V8C ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT HHT01ZNK31 ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Carboxymethylcellulose Sodium INACTIVE INGREDIENT K679OBS311 ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Edetate Disodium INACTIVE INGREDIENT 7FLD91C86K ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Guar Gum INACTIVE INGREDIENT E89I1637KE ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Propylene Glycol INACTIVE INGREDIENT 6DC9Q167V3 ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10 Water INACTIVE INGREDIENT 059QF0KO0R ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.] 10
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0065-1750-14 00065175014 1 BOTTLE, DROPPER in 1 CARTON (0065-1750-14) > 3 mL in 1 BOTTLE, DROPPER 2012-12-20 2021-11-30 No No Current