Home NDC 0078-0743-96 ILEVRO
Product NDC 0078-0743
Requested package NDC 0078-0743-96
11-digit product format 000780743
Labeler code 0078
Product ID 0078-0743_4e6e6db9-e1cf-83cb-e063-6294a90a2420
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nepafenac
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Novartis Pharmaceuticals Corporation
Application NDA203491
Marketing category NDA
Marketing start 2012-12-20
Substance NEPAFENAC
Active strength 3 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 · 9 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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…
Additional Listing Data#
Finished product Yes
Brand name base ILEVRO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NEPAFENAC 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J9L7J6V8C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1362132 Internal RxNorm lookup 1365866 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 0078-0743-03 ILEVRO 3 mL in 1 BOTTLE SUSPENSION/ DROPS 3 5 0078-0743-03 ILEVRO 1 in 1 CARTON SUSPENSION/ DROPS 1 5 0078-0743-96 ILEVRO 1 in 1 CARTON SUSPENSION/ DROPS 1 5 0078-0743-96 ILEVRO 0.8 mL in 1 BOTTLE SUSPENSION/ DROPS 0.8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0743 ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 4 Current NDC, Legacy NDC, 4 package rows 20230421_f089b583-0310-4ca8-8d41-52b06b08d1ed.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 0078-0743-96 00078074396 1 BOTTLE in 1 CARTON (0078-0743-96) > .8 mL in 1 BOTTLE 1 bottle 2021-01-15 0000-00-00 Yes No Current