NEVANAC

Product NDC
0078-0778
11-digit product format
000780778
Labeler code
0078
Product ID
0078-0778_a2909252-c5f1-421f-9073-b7be90b45b51
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA021862
Marketing category
NDA
Marketing start
2005-09-06
Marketing end
0000-00-00
Substance
NEPAFENAC
Active strength
1 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
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0078-0778IInactivated by FDA2026-08-03
excluded packagepackage0078-07780078-0778-03IInactivated by FDA2026-08-03

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 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-0778-03IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0078-0778-03IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0078-0778-03IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0078-0778-03IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0078-0778-03IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0078-0778-03IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0078-0778-03UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0078-0778-03UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0078-0778-03UExcluded 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
N021862-001NEVANACNEPAFENAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021862-00178340592027-01-31U-10952010-11-30

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 UTC2026-02N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-193f01610625f2…
2019-09-15 20:21 UTC2019-09N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021862-001NEVANAC0.1%SUSPENSION/DROPS / OPHTHALMICRLD, RS2005-08-19cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 3 · 119 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021862-00178340592027-01-31U-10952010-11-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00180716482025-12-02Drug product2011-12-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00183242812025-12-02Drug product2012-12-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021862-00178340592027-01-31U-10952010-11-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021862-00180716482025-12-02Drug product2011-12-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021862-00183242812025-12-02Drug product2012-12-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021862-00178340592027-01-31U-10952010-11-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00180716482025-12-02Drug product2011-12-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00183242812025-12-02Drug product2012-12-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021862-00178340592027-01-31U-10952010-11-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00180716482025-12-02Drug product2011-12-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00183242812025-12-02Drug product2012-12-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021862-00178340592027-01-31U-10952010-11-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00180716482025-12-02Drug product2011-12-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00183242812025-12-02Drug product2012-12-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021862-00178340592027-01-31U-10952010-11-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00180716482025-12-02Drug product2011-12-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00183242812025-12-02Drug product2012-12-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021862-00178340592027-01-31U-10952010-11-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00180716482025-12-02Drug product2011-12-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00183242812025-12-02Drug product2012-12-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021862-00178340592027-01-31U-10952010-11-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00180716482025-12-02Drug product2011-12-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00183242812025-12-02Drug product2012-12-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021862-00178340592027-01-31U-10952010-11-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021862-00180716482025-12-02Drug product2011-12-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N021862-00183242812025-12-02Drug product2012-12-17d06236e962d9…
2024-10-29 15:01 UTC2024-10N021862-00178340592027-01-31U-10952010-11-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00180716482025-12-02Drug product2011-12-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00183242812025-12-02Drug product2012-12-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021862-00178340592027-01-31U-10952010-11-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00180716482025-12-02Drug product2011-12-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00183242812025-12-02Drug product2012-12-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021862-00178340592027-01-31U-10952010-11-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00180716482025-12-02Drug product2011-12-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00183242812025-12-02Drug product2012-12-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021862-00178340592027-01-31U-10952010-11-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021862-00180716482025-12-02Drug product2011-12-168072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021862-00183242812025-12-02Drug product2012-12-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021862-00178340592027-01-31U-10952010-11-308072bd15b7f6…

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
0078-0778-03NEVANAC3 mL in 1 BOTTLESUSPENSION/ DROPS32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0778-03ML - Milliliter0078-077864e45c5f-0c08-430c-9d3d-78c1390b78f112023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0778NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]2Legacy NDC, 1 package rows20230420_a2909252-c5f1-421f-9073-b7be90b45b51.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NEVANACNEPAFENACHarrow Eye, LLC11b9a0cf-2a70-17ef-e063-6394a90a5d9e2024-11-05Warnings, Adverse reactionsExact identifier
application applno (NDA): 021862
application number: NDA021862

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578044nepafenac 0.1 % Ophthalmic SuspensionPSNa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 0.1 % Ophthalmic SuspensionPSNa2909252-c5f1-421f-9073-b7be90b45b512
603978nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]SBDa2909252-c5f1-421f-9073-b7be90b45b512
578044nepafenac 1 MG/ML Ophthalmic SuspensionSCDa2909252-c5f1-421f-9073-b7be90b45b512
578044nepafenac 0.1 % Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 0.1 % Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512
603978Nevanac 1 MG/ML Ophthalmic SuspensionSYa2909252-c5f1-421f-9073-b7be90b45b512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0778-03000780778033 mL in 1 BOTTLE (0078-0778-03) 3 ml2022-07-050000-00-00NoNoCurrent