ILEVRO

Product NDC: 0065-1750
11-digit product format: 000651750
Labeler code: 0065
Product ID: 0065-1750_36ff7e36-d529-4e61-ac2e-2e43d37629d8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: nepafenac
Dosage form: SUSPENSION
Route: OPHTHALMIC
Labeler: Alcon Laboratories, Inc.
Application: NDA203491
Marketing category: NDA
Marketing start: 2012-12-20
Marketing end: 2021-11-30
Substance: NEPAFENAC
Active strength: 3 mg/mL
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0065-1750		D	Discontinued by firm	2026-08-03
excluded package	package	0065-1750	0065-1750-07	D	Discontinued by firm	2026-08-03
excluded package	package	0065-1750	0065-1750-08	D	Discontinued by firm	2026-08-03
excluded package	package	0065-1750	0065-1750-14	D	Discontinued by firm	2026-08-03

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1750-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1750-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-1750-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1750-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1750-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-1750-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1750-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1750-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-1750-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1750-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1750-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-1750-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1750-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1750-14	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-1750-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1750-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1750-14	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-1750-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1750-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1750-14	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-1750-08	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1750-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1750-14	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-1750-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1750-07	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1750-14	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-1750-08	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1750-07	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1750-14	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-1750-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1750-07	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1750-14	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-1750-08	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1750-07	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1750-14	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-1750-08	`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
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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-1750-07	ML - Milliliter	0065-1750	cb042279-5cff-4cbe-9a0a-3fb22cb5b536	1	2013-02-13
0065-1750-14	ML - Milliliter	0065-1750	92893683-cfcb-4c66-b97e-6e5f0ec1438a	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Nepafenac	ACTIVE INGREDIENT	0J9L7J6V8C	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Nepafenac	ACTIVE MOIETY	0J9L7J6V8C	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Benzalkonium Chloride	INACTIVE INGREDIENT	F5UM2KM3W7	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Boric Acid	INACTIVE INGREDIENT	R57ZHV85D4	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)	INACTIVE INGREDIENT	HHT01ZNK31	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Carboxymethylcellulose Sodium	INACTIVE INGREDIENT	K679OBS311	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Guar Gum	INACTIVE INGREDIENT	E89I1637KE	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10
Water	INACTIVE INGREDIENT	059QF0KO0R	ILEVRO (NEPAFENAC) SUSPENSION [ALCON LABORATORIES, INC.]	10

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0065-1750-07	00065175007	1 BOTTLE, DROPPER in 1 CARTON (0065-1750-07) > 1.7 mL in 1 BOTTLE, DROPPER	2012-12-20	0000-00-00	No	No	Current
0065-1750-08	00065175008	1 BOTTLE, DROPPER in 1 CARTON (0065-1750-08) > .8 mL in 1 BOTTLE, DROPPER	2012-12-20	0000-00-00	No	No	Current
0065-1750-14	00065175014	1 BOTTLE, DROPPER in 1 CARTON (0065-1750-14) > 3 mL in 1 BOTTLE, DROPPER	2012-12-20	2021-11-30	No	No	Current