NEVANAC

Product NDC: 0065-0002
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

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	0065-0002		D	Discontinued by firm	2026-08-03
excluded product	product	0065-0002		D	Discontinued by firm	2026-08-03
excluded package	package	0065-0002	0065-0002-03	D	Discontinued by firm	2026-08-03
excluded package	package	0065-0002	0065-0002-01	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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-0002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0065-0002-03	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-0002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0065-0002-03	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-0002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0065-0002-03	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-0002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0065-0002-03	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-0002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0065-0002-03	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-0002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0065-0002-03	`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 product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-0002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0065-0002-03	`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 product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-0002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0065-0002-03	`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 product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-0002-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0065-0002-03	`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 product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-0002-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0065-0002-03	`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 product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-0002-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0065-0002-03	`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 product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-0002-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0065-0002-03	`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	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#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0065-0002-03	ML - Milliliter	0065-0002	8b2004cc-d398-4573-8c50-157c1045b250	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
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

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
578044	nepafenac 0.1 % Ophthalmic Suspension	PSN	52fe0332-388a-451c-b759-97e760883837	1
603978	Nevanac 0.1 % Ophthalmic Suspension	PSN	52fe0332-388a-451c-b759-97e760883837	1
603978	nepafenac 1 MG/ML Ophthalmic Suspension [Nevanac]	SBD	52fe0332-388a-451c-b759-97e760883837	1
578044	nepafenac 1 MG/ML Ophthalmic Suspension	SCD	52fe0332-388a-451c-b759-97e760883837	1
578044	nepafenac 0.1 % Ophthalmic Suspension	SY	52fe0332-388a-451c-b759-97e760883837	1
603978	Nevanac 0.1 % Ophthalmic Suspension	SY	52fe0332-388a-451c-b759-97e760883837	1
603978	Nevanac 1 MG/ML Ophthalmic Suspension	SY	52fe0332-388a-451c-b759-97e760883837	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
NEVANAC	Alcon Laboratories, Inc.	2023-01-30	HUMAN PRESCRIPTION DRUG LABEL	14
Nevanac	Physicians Total Care, Inc.	2011-08-31	HUMAN PRESCRIPTION DRUG LABEL	1