FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS35 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiEC2CNF7XFP
Rxcui1009462, 1011703

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82584-792-01AKTEN1 mL in 1 TUBEGEL19
82584-792-01AKTEN1 in 1 CARTONGEL19
82584-792-25AKTEN1 mL in 1 TUBEGEL19
82584-792-25AKTEN25 in 1 CARTONGEL259

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82584-792-01ML - Milliliter82584-792d246926a-accf-4d15-b22b-804054bc28da12023-08-08
82584-792-25ML - Milliliter82584-7924ba93775-efe7-46dd-81e4-8ef53004f2d112023-08-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82584-792AKTEN (LIDOCAINE HYDROCHLORIDE ANHYDROUS) GEL [THEA PHARMA INC.]5Current NDC, Legacy NDC, 4 package rows20240420_70ff9fb7-d323-4fe6-b1b1-6033e05f0749.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011703Akten 3.5 % Ophthalmic GelPSN70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1009462lidocaine HCl 3.5 % Ophthalmic GelPSN70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1011703lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]SBD70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1009462lidocaine hydrochloride 0.035 MG/MG Ophthalmic GelSCD70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1011703Akten 0.035 MG/MG Ophthalmic GelSY70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1011703Akten 3.5 % Ophthalmic GelSY70ff9fb7-d323-4fe6-b1b1-6033e05f07499
1009462lidocaine hydrochloride 3.5 % Ophthalmic GelSY70ff9fb7-d323-4fe6-b1b1-6033e05f07499

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82584-792-01825840792011 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBE1 tube2022-12-010000-00-00NoNoCurrent
82584-792-258258407922525 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBE25 tube2022-12-010000-00-00NoNoCurrent