Home NDC 0065-0002-03 NEVANAC
Product NDC 0065-0002
Requested package NDC 0065-0002-03
11-digit product format 000650002
Labeler code 0065
Product ID 0065-0002_11a9d60d-4ea7-4c77-aee4-232a4df6591b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name nepafenac
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Alcon Laboratories, Inc.
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 · 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 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# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NEPAFENAC ACTIVE INGREDIENT 0J9L7J6V8C NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 NEPAFENAC ACTIVE MOIETY 0J9L7J6V8C NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) INACTIVE INGREDIENT HHT01ZNK31 NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 WATER INACTIVE INGREDIENT 059QF0KO0R NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.] 5 NEPAFENAC ACTIVE INGREDIENT 0J9L7J6V8C NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 NEPAFENAC ACTIVE MOIETY 0J9L7J6V8C NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) INACTIVE INGREDIENT K61870Z308 NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 HYDROCHLORIC ACID INACTIVE INGREDIENT QTT17582CB NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 MANNITOL INACTIVE INGREDIENT 3OWL53L36A NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R NEVANAC (NEPAFENAC) SUSPENSION [PHYSICIANS TOTAL CARE, INC.] 1
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 0065-0002-03 00065000203 3 mL in 1 BOTTLE, PLASTIC (0065-0002-03) 3 ml 2005-09-06 0000-00-00 No No Current