ILEVRO

Product NDC: 0078-0743
11-digit product format: 000780743
Labeler code: 0078
Product ID: 0078-0743_4e6e6db9-e1cf-83cb-e063-6294a90a2420
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nepafenac
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA203491
Marketing category: NDA
Marketing start: 2012-12-20
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0078-0743	0078-0743-03	D	Discontinued by firm		2026-08-03
excluded package	package	0078-0743	0078-0743-96	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 27 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product	0078-0743		I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0078-0743	0078-0743-03	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0078-0743	0078-0743-96	I	Inactivated by FDA	excluded / ndc_excluded.zip	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product	0078-0743		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0078-0743	0078-0743-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0078-0743	0078-0743-96	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product	0078-0743		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0078-0743	0078-0743-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0078-0743	0078-0743-96	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product	0078-0743		U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0078-0743	0078-0743-03	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0078-0743	0078-0743-96	U	Excluded because listing certification expired	excluded / ndc_excluded.zip	`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
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 0078-0743
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

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
f089b583-0310-4ca8-8d41-52b06b08d1ed	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e884a219-2715-9672-1489-3e3d6a8897e6	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0078-0743-03	2025-01-30	C162847	48780-1	2cef2736-81fe-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ILEVRO ® safely and effectively. See full prescribing information for ILEVRO. ILEVRO ® (nepafenac ophthalmic suspension), topical ophthalmic Initial U.S. Approval: 2005
0078-0743-96	2025-01-30	C162847	48780-1	2cef2736-81fe-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ILEVRO ® safely and effectively. See full prescribing information for ILEVRO. ILEVRO ® (nepafenac ophthalmic suspension), topical ophthalmic Initial U.S. Approval: 2005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0078-0743-03	ILEVRO	3 mL in 1 BOTTLE	SUSPENSION/ DROPS	3	5
0078-0743-03	ILEVRO	1 in 1 CARTON	SUSPENSION/ DROPS	1	5
0078-0743-96	ILEVRO	1 in 1 CARTON	SUSPENSION/ DROPS	1	5
0078-0743-96	ILEVRO	0.8 mL in 1 BOTTLE	SUSPENSION/ DROPS	0.8	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0743-03	ML - Milliliter	0078-0743	af0eb0ff-6cf8-4c1c-b651-88ec06006685	1	2021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0743	ILEVRO (NEPAFENAC) SUSPENSION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION]	4	Current NDC, Legacy NDC, 4 package rows	20230421_f089b583-0310-4ca8-8d41-52b06b08d1ed.zip

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	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1362132	nepafenac 0.3 % Ophthalmic Suspension	PSN	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1365866	nepafenac 3 MG/ML Ophthalmic Suspension [Ilevro]	SBD	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1362132	nepafenac 3 MG/ML Ophthalmic Suspension	SCD	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1365866	Ilevro 0.3 % Ophthalmic Suspension	SY	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1365866	Ilevro 3 MG/ML Ophthalmic Suspension	SY	f089b583-0310-4ca8-8d41-52b06b08d1ed	5
1362132	nepafenac 0.3 % Ophthalmic Suspension	SY	f089b583-0310-4ca8-8d41-52b06b08d1ed	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0743-03	00078074303	1 BOTTLE in 1 CARTON (0078-0743-03) > 3 mL in 1 BOTTLE	1 bottle	2021-01-15	0000-00-00	No	No	Current
0078-0743-96	00078074396	1 BOTTLE in 1 CARTON (0078-0743-96) > .8 mL in 1 BOTTLE	1 bottle	2021-01-15	0000-00-00	Yes	No	Current