NDC 17478-792

Akten

Lidocaine Hydrochloride

Akten is a Ophthalmic Gel in the Human Prescription Drug category. It is labeled and distributed by Akorn, Inc.. The primary component is Lidocaine Hydrochloride Anhydrous.

Product ID17478-792_164cf8c8-2533-423d-9609-210f49269a1b
NDC17478-792
Product TypeHuman Prescription Drug
Proprietary NameAkten
Generic NameLidocaine Hydrochloride
Dosage FormGel
Route of AdministrationOPHTHALMIC
Marketing Start Date2008-10-08
Marketing CategoryNDA / NDA
Application NumberNDA022221
Labeler NameAkorn, Inc.
Substance NameLIDOCAINE HYDROCHLORIDE ANHYDROUS
Active Ingredient Strength35 mg/mL
Pharm ClassesAmide Local Anesthetic [EPC],Amides [CS],Antiarrhythmic [EPC],Local Anesthesia [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 17478-792-01

1 TUBE in 1 CARTON (17478-792-01) > 1 mL in 1 TUBE
Marketing Start Date2012-12-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-792-10 [17478079210]

Akten GEL
Marketing CategoryNDA
Application NumberNDA022221
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-10-08

NDC 17478-792-25 [17478079225]

Akten GEL
Marketing CategoryNDA
Application NumberNDA022221
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-03-11

NDC 17478-792-01 [17478079201]

Akten GEL
Marketing CategoryNDA
Application NumberNDA022221
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-12-07

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE HYDROCHLORIDE ANHYDROUS35 mg/mL

OpenFDA Data

SPL SET ID:c1f638dc-c386-45e8-9adc-d0f295794679
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1011703
  • 1009462
    • UPC Code
  • 0317478792017

    • Pharmacological Class

    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]
    • Amide Local Anesthetic [EPC]
    • Amides [CS]
    • Antiarrhythmic [EPC]
    • Local Anesthesia [PE]

    NDC Crossover Matching brand name "Akten" or generic name "Lidocaine Hydrochloride"

    NDCBrand NameGeneric Name
    17478-792AktenAkten
    0143-9575LidocaineLidocaine Hydrochloride
    0143-9576LidocaineLidocaine Hydrochloride
    0143-9577LidocaineLidocaine Hydrochloride
    0143-9578LidocaineLidocaine Hydrochloride
    0143-9579LidocaineLIDOCAINE HYDROCHLORIDE
    0054-3505Lidocaine HydrochlorideLidocaine Hydrochloride
    0143-9594Lidocaine HydrochlorideLidocaine Hydrochloride
    0143-9595Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDE
    0264-9376LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE
    0404-9885LIDOCAINE HYDROCHLORIDELIDOCAINE HYDROCHLORIDE
    0404-9889Lidocaine HydrochlorideLidocaine Hydrochloride
    0338-0409Lidocaine Hydrochloride and DextroseLidocaine Hydrochloride
    0338-0411Lidocaine Hydrochloride and DextroseLidocaine Hydrochloride
    0338-9586Lidocaine Hydrochloride and DextroseLidocaine Hydrochloride
    0338-9590Lidocaine Hydrochloride and DextroseLidocaine Hydrochloride
    0054-3500Lidocaine ViscousLidocaine Hydrochloride
    0121-0903Lidocaine ViscousLidocaine Hydrochloride
    0295-1110SunBurnt PLUS Pain ReliefLidocaine Hydrochloride
    0363-9919WALG AFTRSN BURN RELIEFLIDOCAINE HYDROCHLORIDE
    0363-7790Walgreen Pain RelievingLidocaine Hydrochloride
    0363-4000Walgreens Aloe Vera Burn ReliefLIDOCAINE HYDROCHLORIDE
    0363-2020WALGREENS BURNlidocaine hydrochloride
    0363-0290Walgreens Burn reliefLidocaine Hydrochloride
    0363-0954Walgreens CoolingLidocaine Hydrochloride
    0363-0978Walgreens Sunburn ReliefLidocaine Hydrochloride

    Trademark Results [Akten]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AKTEN
    AKTEN
    77012922 3631872 Live/Registered
    Akorn Inc.
    2006-10-03
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