Home NDC 0078-0778 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 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0078-0778-03 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0078-0778-03 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 0078-0778-03 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 0078-0778-03 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 0078-0778-03 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 0078-0778-03 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 0078-0778-03 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 0078-0778-03 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 0078-0778-03 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 N021862-001 NEVANAC NEPAFENAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021862-001 7834059 2027-01-31 U-1095 2010-11-30
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 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 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021862-001 NEVANAC 0.1% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 2005-08-19 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 3 · 119 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 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021862-001 8071648 2025-12-02 Drug product 2011-12-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021862-001 8324281 2025-12-02 Drug product 2012-12-17 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021862-001 7834059 2027-01-31 U-1095 2010-11-30 8072bd15b7f6…
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 0078-0778-03 NEVANAC 3 mL in 1 BOTTLE SUSPENSION/ DROPS 3 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0078-0778 NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] 2 Legacy NDC, 1 package rows 20230420_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join NEVANAC NEPAFENAC Harrow Eye, LLC 11b9a0cf-2a70-17ef-e063-6394a90a5d9e 2024-11-05 Warnings, Adverse reactions Exact identifier application applno (NDA): 021862 application number: NDA021862
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 0078-0778-03 00078077803 3 mL in 1 BOTTLE (0078-0778-03) 3 ml 2022-07-05 0000-00-00 No No Current