FDA.reportPublic FDA data

NEVANAC

Product NDC
82667-500
11-digit product format
826670500
Labeler code
82667
Product ID
82667-500_42dbdcfd-3edd-46a3-e063-6394a90ac694
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
nepafenac
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Harrow Eye, LLC
Application
NDA021862
Marketing category
NDA
Marketing start
2025-01-01
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
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
NEVANAC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
NEPAFENAC1 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
578044Internal RxNorm lookup
603978Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11b9a0cf-2a70-17ef-e063-6394a90a5d9eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
e884a219-2715-9672-1489-3e3d6a8897e6Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82667-500-03NEVANAC1 in 1 CARTONSUSPENSION/ DROPS13
82667-500-03NEVANAC3 mL in 1 BOTTLE, PLASTICSUSPENSION/ DROPS33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82667-500-03ML - Milliliter82667-50049a258c7-232f-4fca-8a94-4f3d74869ebb12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82667-500NEVANAC (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC]1Current NDC, 2 package rows20250101_11b9a0cf-2a70-17ef-e063-6394a90a5d9e.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
ndc (product): 82667-500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
578044nepafenac 0.1 % Ophthalmic SuspensionPSN11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 0.1 % Ophthalmic SuspensionPSN11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]SBD11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
578044nepafenac 1 MG/ML Ophthalmic SuspensionSCD11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
578044nepafenac 0.1 % Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 0.1 % Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3
603978Nevanac 1 MG/ML Ophthalmic SuspensionSY11b9a0cf-2a70-17ef-e063-6394a90a5d9e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82667-500-03826670500031 BOTTLE, PLASTIC in 1 CARTON (82667-500-03) / 3 mL in 1 BOTTLE, PLASTIC2025-01-01NoNoCurrent