AKTEN

Product NDC: 82584-792
Requested package NDC: 82584-792-25
11-digit product format: 825840792
Labeler code: 82584
Product ID: 82584-792_50281c7f-d484-86d7-e063-6394a90af6ff
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LIDOCAINE HYDROCHLORIDE ANHYDROUS
Dosage form: GEL
Route: OPHTHALMIC
Labeler: Thea Pharma Inc.
Application: NDA022221
Marketing category: NDA
Marketing start: 2022-12-01
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS	35 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EC2CNF7XFP	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1009462	Internal RxNorm lookup
1011703	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
70ff9fb7-d323-4fe6-b1b1-6033e05f0749	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
070fbed5-7088-434a-a7ce-f2a64d8d40ac	Product name	2	20260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80f	Product name	5	20250819
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
7d755fa1-1087-4dcd-98f0-6d4bba479a57	Product name	3	20210602
aed701d5-9c75-dfaf-7154-cde46179faea	Product name	9	20200313
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
49fa150c-f0de-cce7-3d9c-993ed81c5698	Product name	1	20140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ff	Product name	1	20140508
9137811f-f279-8640-5aeb-99fa2145d64d	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82584-792-01	AKTEN	1 mL in 1 TUBE	GEL	1	9
82584-792-01	AKTEN	1 in 1 CARTON	GEL	1	9
82584-792-25	AKTEN	1 mL in 1 TUBE	GEL	1	9
82584-792-25	AKTEN	25 in 1 CARTON	GEL	25	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82584-792-01	ML - Milliliter	82584-792	d246926a-accf-4d15-b22b-804054bc28da	1	2023-08-08
82584-792-25	ML - Milliliter	82584-792	4ba93775-efe7-46dd-81e4-8ef53004f2d1	1	2023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82584-792	AKTEN (LIDOCAINE HYDROCHLORIDE ANHYDROUS) GEL [THEA PHARMA INC.]	5	Current NDC, Legacy NDC, 4 package rows	20240420_70ff9fb7-d323-4fe6-b1b1-6033e05f0749.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 ndc (package): 82584-792-25 ndc (product): 82584-792 ndc11 (package): 82584079225

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EC2CNF7XFP	LIDOCAINE HYDROCHLORIDE ANHYDROUS	73-78-9	LIDOCAINE HYDROCHLORIDE ANHYDROUS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1011703	Akten 3.5 % Ophthalmic Gel	PSN	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1009462	lidocaine HCl 3.5 % Ophthalmic Gel	PSN	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1011703	lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]	SBD	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1009462	lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel	SCD	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1011703	Akten 0.035 MG/MG Ophthalmic Gel	SY	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1011703	Akten 3.5 % Ophthalmic Gel	SY	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9
1009462	lidocaine hydrochloride 3.5 % Ophthalmic Gel	SY	70ff9fb7-d323-4fe6-b1b1-6033e05f0749	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82584-792-25	82584079225	25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE	25 tube	2022-12-01	0000-00-00	No	No	Current