Akten

Product NDC: 17478-792
11-digit product format: 174780792
Labeler code: 17478
Product ID: 17478-792_1e6f4e83-c810-41fe-a93b-2f8e6fdecbbf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Lidocaine Hydrochloride
Dosage form: GEL
Route: OPHTHALMIC
Labeler: Akorn
Application: NDA022221
Marketing category: NDA
Marketing start: 2008-10-08
Marketing end: 0000-00-00
Substance: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Active strength: 35 mg/mL
Pharmacologic classes: Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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	17478-792		I	Inactivated by FDA	2026-08-03
excluded package	package	17478-792	17478-792-01	I	Inactivated by FDA	2026-08-03
excluded package	package	17478-792	17478-792-10	D	Discontinued by firm	2026-08-03
excluded package	package	17478-792	17478-792-25	I	Inactivated by FDA	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 · 57 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-792-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-792-25	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17478-792-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-792-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-792-25	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17478-792-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-792-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-792-25	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17478-792-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-792-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-792-25	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17478-792-10	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-792-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-792-25	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17478-792-10	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-792-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-792-25	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17478-792-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-792-01	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-792-25	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17478-792-10	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-792-01	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-792-25	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17478-792-10	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-792-01	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-792-25	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17478-792-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-792-01	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-792-25	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17478-792-10	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-792-01	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-792-25	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17478-792-10	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-792-01	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-792-25	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17478-792-10	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-792-01	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17478-792-25	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-792-01	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17478-792-25	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-792-01	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17478-792-25	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
N022221-001	AKTEN	LIDOCAINE HYDROCHLORIDE	3.5%	GEL / OPHTHALMIC		RLD, RS	2008-10-07

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
N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30

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	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022221-001	AKTEN	3.5%	GEL / OPHTHALMIC	RLD, RS	2008-10-07	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 41 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	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022221-001	8759401	2026-07-24	U-1523	Drug product	2014-06-30	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
860a93dc-4863-49cc-b284-6bbe8191bc48	Product name	4	20250214
eaba870a-6a9d-442e-8643-87b3f558a451	Product name	1	20250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86	Product name	1	20230117
fa8b5901-e681-426f-82fe-54f6d81ec698	Product name	4	20180619
332d03e4-aa24-4b11-841a-02bf41081920	Product name	1	20171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070	Product name	1	20171221
68ed98f8-24c2-44a0-944a-6d36e82ce25a	Product name	1	20141222
1cd42bc2-a430-c72b-636d-991b235fbf80	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
17478-792-01	2024-01-30	C162847	48780-1	1030e365-5bf3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1972
17478-792-10	2024-01-30	C162847	48780-1	1030e365-5bf3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1972
17478-792-25	2024-01-30	C162847	48780-1	1030e365-5bf3-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1972

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17478-792-01	Akten	1 in 1 CARTON	GEL	1	15
17478-792-01	Akten	1 mL in 1 TUBE	GEL	1	15
17478-792-10	Akten	1 in 1 CARTON	GEL	1	15
17478-792-10	Akten	5 mL in 1 BOTTLE, DROPPER	GEL	5	15
17478-792-25	Akten	1 mL in 1 TUBE	GEL	1	15
17478-792-25	Akten	25 in 1 CARTON	GEL	25	15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17478-792-01	ML - Milliliter	17478-792	2a5522b2-f2ed-476a-b8a3-73f9a18992cf	1	2013-02-13
17478-792-10	ML - Milliliter	17478-792	ec647c78-2e35-4247-aa1c-72c9faba3be4	1	2012-07-24
17478-792-25	ML - Milliliter	17478-792	e25addf5-37f3-417d-bc73-c3cd21e39d96	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Lidocaine Hydrochloride Anhydrous	ACTIVE INGREDIENT	EC2CNF7XFP	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Lidocaine	ACTIVE MOIETY	98PI200987	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Hydrochloric Acid	INACTIVE INGREDIENT	QTT17582CB	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8
Water	INACTIVE INGREDIENT	059QF0KO0R	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17478-792	AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN]	15	Legacy NDC, 6 package rows	20220503_c1f638dc-c386-45e8-9adc-d0f295794679.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AKTEN	LIDOCAINE HYDROCHLORIDE ANHYDROUS	Thea Pharma Inc.	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022221 application number: NDA022221

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS
V13007Z41A	LIDOCAINE HYDROCHLORIDE	6108-05-0	Lidocaine Hydrochloride

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011703	Akten 3.5 % Ophthalmic Gel	PSN	c1f638dc-c386-45e8-9adc-d0f295794679	15
1009462	lidocaine HCl 3.5 % Ophthalmic Gel	PSN	c1f638dc-c386-45e8-9adc-d0f295794679	15
1011703	lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]	SBD	c1f638dc-c386-45e8-9adc-d0f295794679	15
1009462	lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel	SCD	c1f638dc-c386-45e8-9adc-d0f295794679	15
1011703	Akten 0.035 MG/MG Ophthalmic Gel	SY	c1f638dc-c386-45e8-9adc-d0f295794679	15
1011703	Akten 3.5 % Ophthalmic Gel	SY	c1f638dc-c386-45e8-9adc-d0f295794679	15
1009462	lidocaine hydrochloride 3.5 % Ophthalmic Gel	SY	c1f638dc-c386-45e8-9adc-d0f295794679	15

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17478-792-01	17478079201	1 TUBE in 1 CARTON (17478-792-01) > 1 mL in 1 TUBE	1 tube	2012-12-07	0000-00-00	No	No	Current
17478-792-10	17478079210	1 BOTTLE, DROPPER in 1 CARTON (17478-792-10) > 5 mL in 1 BOTTLE, DROPPER		2008-10-08	0000-00-00	No	No	Current
17478-792-25	17478079225	25 TUBE in 1 CARTON (17478-792-25) > 1 mL in 1 TUBE	25 tube	2014-03-11	0000-00-00	No	No	Current