Home NDC 82584-792 AKTEN
Product NDC 82584-792
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 Product TE source text 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.
DailyMed Product Concepts# DailyMed Package Descriptions# 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 (product): 82584-792
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 82584-792-01 82584079201 1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE 1 tube 2022-12-01 0000-00-00 No No Current 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