ILEVRO

Product NDC: 82667-400
11-digit product format: 826670400
Labeler code: 82667
Product ID: 82667-400_4e6f184f-0de5-acca-e063-6394a90ac321
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nepafenac
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Harrow Eye, LLC
Application: NDA203491
Marketing category: NDA
Marketing start: 2024-05-01
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

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
N203491-001	ILEVRO	NEPAFENAC	0.3%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	2012-10-16

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N203491-001	9662398	2030-12-01		Drug product	2017-06-02
N203491-001	8921337	2032-03-31		Drug product	2015-06-08

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N203491-001	ILEVRO	0.3%	SUSPENSION/DROPS / OPHTHALMIC	RLD, RS	2012-10-16	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 117 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203491-001	7947295	2024-06-08	Drug product	2013-02-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203491-001	9662398	2030-12-01	Drug product	2017-06-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N203491-001	8921337	2032-03-31	Drug product	2015-06-08	`5c6f7cd8ea54…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
NEPAFENAC	3 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0J9L7J6V8C	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
10f411d3-a81e-074a-e063-6294a90ab547	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
e884a219-2715-9672-1489-3e3d6a8897e6	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82667-400-03	ILEVRO	1 in 1 CARTON	SUSPENSION/ DROPS	1		5
82667-400-03	ILEVRO	3 mL in 1 BOTTLE, PLASTIC	SUSPENSION/ DROPS	3		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82667-400-03	ML - Milliliter	82667-400	b7fd231f-034c-4636-97e7-9d56f9aa98e4	1	2025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82667-400	ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [HARROW EYE, LLC]	1	Current NDC, 2 package rows	20240501_10f411d3-a81e-074a-e063-6294a90ab547.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ILEVRO	NEPAFENAC	Novartis Pharmaceuticals Corporation	f089b583-0310-4ca8-8d41-52b06b08d1ed	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203491 application number: NDA203491
ILEVRO	NEPAFENAC	Harrow Eye, LLC	10f411d3-a81e-074a-e063-6294a90ab547	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (NDA): 203491 application number: NDA203491 ndc (product): 82667-400

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0J9L7J6V8C	NEPAFENAC	78281-72-8	NEPAFENAC

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1365866	ILEVRO 0.3 % Ophthalmic Suspension	PSN	10f411d3-a81e-074a-e063-6294a90ab547	5
1362132	nepafenac 0.3 % Ophthalmic Suspension	PSN	10f411d3-a81e-074a-e063-6294a90ab547	5
1365866	nepafenac 3 MG/ML Ophthalmic Suspension [Ilevro]	SBD	10f411d3-a81e-074a-e063-6294a90ab547	5
1362132	nepafenac 3 MG/ML Ophthalmic Suspension	SCD	10f411d3-a81e-074a-e063-6294a90ab547	5
1365866	Ilevro 0.3 % Ophthalmic Suspension	SY	10f411d3-a81e-074a-e063-6294a90ab547	5
1365866	Ilevro 3 MG/ML Ophthalmic Suspension	SY	10f411d3-a81e-074a-e063-6294a90ab547	5
1362132	nepafenac 0.3 % Ophthalmic Suspension	SY	10f411d3-a81e-074a-e063-6294a90ab547	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82667-400-03	82667040003	1 BOTTLE, PLASTIC in 1 CARTON (82667-400-03) / 3 mL in 1 BOTTLE, PLASTIC	2024-05-01	No	No	Current