NDC 63402-208

Aptiom

Eslicarbazepine Acetate

Aptiom is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Sunovion Pharmaceuticals Inc.. The primary component is Eslicarbazepine Acetate.

Product ID63402-208_05e586b4-1a22-4825-90e8-21053a1b570a
NDC63402-208
Product TypeHuman Prescription Drug
Proprietary NameAptiom
Generic NameEslicarbazepine Acetate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-04-07
Marketing CategoryNDA / NDA
Application NumberNDA022416
Labeler NameSunovion Pharmaceuticals Inc.
Substance NameESLICARBAZEPINE ACETATE
Active Ingredient Strength800 mg/1
Pharm ClassesDecreased Central Nervous System Disorganized Electrical Activity [PE],Cytochrome P450 3A4 Inducers [MoA],Cytochrome P450 2C19 Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63402-208-28

4 BLISTER PACK in 1 CARTON (63402-208-28) > 7 TABLET in 1 BLISTER PACK (63402-208-07)
Marketing Start Date2014-04-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63402-208-28 [63402020828]

Aptiom TABLET
Marketing CategoryNDA
Application NumberNDA022416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-07

NDC 63402-208-07 [63402020807]

Aptiom TABLET
Marketing CategoryNDA
Application NumberNDA022416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-07

NDC 63402-208-30 [63402020830]

Aptiom TABLET
Marketing CategoryNDA
Application NumberNDA022416
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-04-07

NDC 63402-208-90 [63402020890]

Aptiom TABLET
Marketing CategoryNDA
Application NumberNDA022416
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-04-07
Marketing End Date2019-03-28

Drug Details

Active Ingredients

IngredientStrength
ESLICARBAZEPINE ACETATE800 mg/1

OpenFDA Data

SPL SET ID:3d0c9554-eaeb-4694-8089-00133fcadce3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1482523
  • 1482521
  • 1482527
  • 1482525
  • 1491643
  • 1491642
  • 1482513
  • 1482507
  • 1482517
  • 1482515
  • Pharmacological Class

    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]
    • Cytochrome P450 3A4 Inducers [MoA]
    • Cytochrome P450 2C19 Inhibitors [MoA]

    Medicade Reported Pricing

    63402020830 APTIOM 800 MG TABLET

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Aptiom" or generic name "Eslicarbazepine Acetate"

    NDCBrand NameGeneric Name
    63402-202AptiomESLICARBAZEPINE ACETATE
    63402-204AptiomESLICARBAZEPINE ACETATE
    63402-206AptiomESLICARBAZEPINE ACETATE
    63402-208AptiomESLICARBAZEPINE ACETATE
    63402-248AptiomESLICARBAZEPINE ACETATE

    Trademark Results [Aptiom]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APTIOM
    APTIOM
    86844180 5220839 Live/Registered
    Bial - Portela & Ca., S.A.
    2015-12-09
    APTIOM
    APTIOM
    86844154 5220838 Live/Registered
    Bial - Portela & Ca., S.A.
    2015-12-09
    APTIOM
    APTIOM
    86844123 5220837 Live/Registered
    Bial - Portela & Ca., S.A.
    2015-12-09
    APTIOM
    APTIOM
    86277162 not registered Live/Pending
    Bial - Portela & Ca., S.A.
    2014-05-09
    APTIOM
    APTIOM
    86277037 5655934 Live/Registered
    Bial - Portela & Ca., S.A.
    2014-05-09
    APTIOM
    APTIOM
    86276883 5348419 Live/Registered
    Bial - Portela & Ca., S.A.
    2014-05-09
    APTIOM
    APTIOM
    77655262 3727530 Live/Registered
    BIAL - PORTELA & CA., S.A.
    2009-01-23

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