FDA.reportPublic FDA data

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17478-792-012024-01-30C16284748780-11030e365-5bf3-111a-e063-dadaa90a10e2These 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
17478-792-102024-01-30C16284748780-11030e365-5bf3-111a-e063-dadaa90a10e2These 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
17478-792-252024-01-30C16284748780-11030e365-5bf3-111a-e063-dadaa90a10e2These 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 NDCProductDescriptionFormQuantityStrengthSPL version
17478-792-01Akten1 in 1 CARTONGEL115
17478-792-01Akten1 mL in 1 TUBEGEL115
17478-792-10Akten1 in 1 CARTONGEL115
17478-792-10Akten5 mL in 1 BOTTLE, DROPPERGEL515
17478-792-25Akten1 mL in 1 TUBEGEL115
17478-792-25Akten25 in 1 CARTONGEL2515

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17478-792-01ML - Milliliter17478-7922a5522b2-f2ed-476a-b8a3-73f9a18992cf12013-02-13
17478-792-10ML - Milliliter17478-792ec647c78-2e35-4247-aa1c-72c9faba3be412012-07-24
17478-792-25ML - Milliliter17478-792e25addf5-37f3-417d-bc73-c3cd21e39d9612015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Lidocaine Hydrochloride AnhydrousACTIVE INGREDIENTEC2CNF7XFPAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
LidocaineACTIVE MOIETY98PI200987AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
HypromellosesINACTIVE INGREDIENT3NXW29V3WOAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8
WaterINACTIVE INGREDIENT059QF0KO0RAKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN, INC. ]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17478-792AKTEN (LIDOCAINE HYDROCHLORIDE) GEL [AKORN]15Legacy NDC, 6 package rows20220503_c1f638dc-c386-45e8-9adc-d0f295794679.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1011703Akten 3.5 % Ophthalmic GelPSNc1f638dc-c386-45e8-9adc-d0f29579467915
1009462lidocaine HCl 3.5 % Ophthalmic GelPSNc1f638dc-c386-45e8-9adc-d0f29579467915
1011703lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]SBDc1f638dc-c386-45e8-9adc-d0f29579467915
1009462lidocaine hydrochloride 0.035 MG/MG Ophthalmic GelSCDc1f638dc-c386-45e8-9adc-d0f29579467915
1011703Akten 0.035 MG/MG Ophthalmic GelSYc1f638dc-c386-45e8-9adc-d0f29579467915
1011703Akten 3.5 % Ophthalmic GelSYc1f638dc-c386-45e8-9adc-d0f29579467915
1009462lidocaine hydrochloride 3.5 % Ophthalmic GelSYc1f638dc-c386-45e8-9adc-d0f29579467915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17478-792-01174780792011 TUBE in 1 CARTON (17478-792-01) > 1 mL in 1 TUBE1 tube2012-12-070000-00-00NoNoCurrent
17478-792-10174780792101 BOTTLE, DROPPER in 1 CARTON (17478-792-10) > 5 mL in 1 BOTTLE, DROPPER2008-10-080000-00-00NoNoCurrent
17478-792-251747807922525 TUBE in 1 CARTON (17478-792-25) > 1 mL in 1 TUBE25 tube2014-03-110000-00-00NoNoCurrent