NDC 70363-007

Aktipak

Erythromycin And Benzoyl Peroxide

Aktipak is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Cutanea Life Sciences, Inc.. The primary component is Erythromycin; Benzoyl Peroxide.

Product ID70363-007_3e4d755d-6203-4e29-9f46-7f2a37e0234e
NDC70363-007
Product TypeHuman Prescription Drug
Proprietary NameAktipak
Generic NameErythromycin And Benzoyl Peroxide
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2017-04-10
Marketing CategoryNDA / NDA
Application NumberNDA050769
Labeler NameCutanea Life Sciences, Inc.
Substance NameERYTHROMYCIN; BENZOYL PEROXIDE
Active Ingredient Strength30 mg/g; mg/g
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Macrolide [EPC],Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70363-007-02

2 POUCH in 1 PACKAGE (70363-007-02) > .8 g in 1 POUCH
Marketing Start Date2018-06-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70363-007-04 [70363000704]

Aktipak GEL
Marketing CategoryNDA
Application NumberNDA050769
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-04-10
Marketing End Date2019-09-30

NDC 70363-007-02 [70363000702]

Aktipak GEL
Marketing CategoryNDA
Application NumberNDA050769
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-27
Marketing End Date2019-09-30

NDC 70363-007-60 [70363000760]

Aktipak GEL
Marketing CategoryNDA
Application NumberNDA050769
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-04-10
Marketing End Date2019-09-30

Drug Details

Active Ingredients

IngredientStrength
ERYTHROMYCIN30 mg/g

OpenFDA Data

SPL SET ID:dc8549bd-eb87-4520-bc1f-9890055659b4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 244374
  • 1876669

    • Pharmacological Class

    • Decreased Sebaceous Gland Activity [PE]
    • Macrolide [EPC]
    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    NDC Crossover Matching brand name "Aktipak" or generic name "Erythromycin And Benzoyl Peroxide"

    NDCBrand NameGeneric Name
    70363-007Aktipakerythromycin and benzoyl peroxide
    0187-5205Benzamycinerythromycin and benzoyl peroxide
    0781-7054Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl Peroxide
    0781-7094Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl Peroxide
    64980-328Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl Peroxide
    68682-900Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl Peroxide
    68682-901Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl Peroxide
    45802-083Erythromycin-Benzoyl Peroxideerythromycin and benzoyl peroxide

    Trademark Results [Aktipak]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AKTIPAK
    AKTIPAK
    87607929 5448116 Live/Registered
    DERMARC LLC
    2017-09-14
    AKTIPAK
    AKTIPAK
    86983093 5324789 Live/Registered
    DERMARC LLC
    2016-03-23
    AKTIPAK
    AKTIPAK
    86950376 not registered Live/Pending
    Cutanea Life Sciences, Inc.
    2016-03-23
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