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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0078-07430078-0743-96DDiscontinued by firm2026-08-03

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 dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203491-001ILEVRONEPAFENAC0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N203491-00196623982030-12-01Drug product2017-06-02
N203491-00189213372032-03-31Drug product2015-06-08

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-1687673890dc5c…
2021-03-12 10:30 UTC2021-03N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-163f01610625f2…
2019-09-15 20:21 UTC2019-09N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16b00525d2431f…
2019-07-19 19:46 UTC2019-07N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-163f0d92c62455…
2023-05-13 08:27 UTC2023-05N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16053a50430f4f…
2023-01-26 05:58 UTC2023-01N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N203491-001ILEVRO0.3%SUSPENSION/DROPS / OPHTHALMICRLD, RS2012-10-16cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N203491-00196623982030-12-01Drug product2017-06-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N203491-00189213372032-03-31Drug product2015-06-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203491-00196623982030-12-01Drug product2017-06-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N203491-00189213372032-03-31Drug product2015-06-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N203491-00196623982030-12-01Drug product2017-06-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N203491-00189213372032-03-31Drug product2015-06-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203491-00196623982030-12-01Drug product2017-06-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N203491-00189213372032-03-31Drug product2015-06-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203491-00196623982030-12-01Drug product2017-06-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N203491-00189213372032-03-31Drug product2015-06-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203491-00179472952024-06-08Drug product2013-02-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203491-00196623982030-12-01Drug product2017-06-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N203491-00189213372032-03-31Drug product2015-06-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203491-00179472952024-06-08Drug product2013-02-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203491-00196623982030-12-01Drug product2017-06-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N203491-00189213372032-03-31Drug product2015-06-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203491-00179472952024-06-08Drug product2013-02-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203491-00196623982030-12-01Drug product2017-06-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N203491-00189213372032-03-31Drug product2015-06-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203491-00179472952024-06-08Drug product2013-02-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203491-00196623982030-12-01Drug product2017-06-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N203491-00189213372032-03-31Drug product2015-06-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N203491-00179472952024-06-08Drug product2013-02-15d06236e962d9…
2024-10-29 15:01 UTC2024-10N203491-00196623982030-12-01Drug product2017-06-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N203491-00189213372032-03-31Drug product2015-06-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203491-00179472952024-06-08Drug product2013-02-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203491-00196623982030-12-01Drug product2017-06-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N203491-00189213372032-03-31Drug product2015-06-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203491-00179472952024-06-08Drug product2013-02-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203491-00196623982030-12-01Drug product2017-06-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N203491-00189213372032-03-31Drug product2015-06-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203491-00179472952024-06-08Drug product2013-02-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203491-00196623982030-12-01Drug product2017-06-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N203491-00189213372032-03-31Drug product2015-06-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N203491-00179472952024-06-08Drug product2013-02-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05N203491-00196623982030-12-01Drug product2017-06-028072bd15b7f6…
2024-05-31 18:47 UTC2024-05N203491-00189213372032-03-31Drug product2015-06-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203491-00179472952024-06-08Drug product2013-02-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203491-00196623982030-12-01Drug product2017-06-025c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N203491-00189213372032-03-31Drug product2015-06-085c6f7cd8ea54…

Additional Listing Data#

Finished product
Yes
Brand name base
ILEVRO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEPAFENAC3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0J9L7J6V8CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1362132Internal RxNorm lookup
1365866Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f089b583-0310-4ca8-8d41-52b06b08d1edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e884a219-2715-9672-1489-3e3d6a8897e6Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0078-0743-03ILEVRO3 mL in 1 BOTTLESUSPENSION/ DROPS35
0078-0743-03ILEVRO1 in 1 CARTONSUSPENSION/ DROPS15
0078-0743-96ILEVRO1 in 1 CARTONSUSPENSION/ DROPS15
0078-0743-96ILEVRO0.8 mL in 1 BOTTLESUSPENSION/ DROPS0.85

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0743-03ML - Milliliter0078-0743af0eb0ff-6cf8-4c1c-b651-88ec0600668512021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0743ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]4Current NDC, Legacy NDC, 4 package rows20230421_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ILEVRONEPAFENACNovartis Pharmaceuticals Corporationf089b583-0310-4ca8-8d41-52b06b08d1ed2026-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 203491
application number: NDA203491
ndc (package): 0078-0743-96
ndc (product): 0078-0743
ndc11 (package): 00078074396
ILEVRONEPAFENACHarrow Eye, LLC10f411d3-a81e-074a-e063-6294a90ab5472026-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 203491
application number: NDA203491

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1365866ILEVRO 0.3 % Ophthalmic SuspensionPSNf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 0.3 % Ophthalmic SuspensionPSNf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866nepafenac 3 MG/ML Ophthalmic Suspension [Ilevro]SBDf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 3 MG/ML Ophthalmic SuspensionSCDf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866Ilevro 0.3 % Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5
1365866Ilevro 3 MG/ML Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5
1362132nepafenac 0.3 % Ophthalmic SuspensionSYf089b583-0310-4ca8-8d41-52b06b08d1ed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0743-96000780743961 BOTTLE in 1 CARTON (0078-0743-96) > .8 mL in 1 BOTTLE1 bottle2021-01-150000-00-00YesNoCurrent