NDC 70518-1349

Trileptal

Oxcarbazepine

Trileptal is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Oxcarbazepine.

Product ID70518-1349_72f2ec5a-e0fa-96ce-e053-2991aa0a7516
NDC70518-1349
Product TypeHuman Prescription Drug
Proprietary NameTrileptal
Generic NameOxcarbazepine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-08-07
Marketing CategoryNDA / NDA
Application NumberNDA021014
Labeler NameREMEDYREPACK INC.
Substance NameOXCARBAZEPINE
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 70518-1349-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-1349-0)
Marketing Start Date2018-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-1349-0 [70518134900]

Trileptal TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021014
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-08-07
Marketing End Date2020-05-20

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE300 mg/1

OpenFDA Data

SPL SET ID:52b9ff8a-34ea-435b-9c90-93d0df4eefa8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312137
  • 261360

    • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    NDC Crossover Matching brand name "Trileptal" or generic name "Oxcarbazepine"

    NDCBrand NameGeneric Name
    0078-0337Trileptaloxcarbazepine
    0078-0357Trileptaloxcarbazepine
    0078-0456Trileptaloxcarbazepine
    0078-0457Trileptaloxcarbazepine
    70518-1300TrileptalTrileptal
    70518-1349TrileptalTrileptal
    55289-007TrileptalTrileptal
    61919-569TRILEPTALTRILEPTAL
    0054-0097OxcarbazepineOxcarbazepine
    0054-0098OxcarbazepineOxcarbazepine
    0054-0099OxcarbazepineOxcarbazepine
    0054-0199OxcarbazepineOxcarbazepine
    0615-6593OxcarbazepineOxcarbazepine
    0615-6594OxcarbazepineOxcarbazepine
    0615-6595OxcarbazepineOxcarbazepine
    0615-8153OxcarbazepineOxcarbazepine

    Trademark Results [Trileptal]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TRILEPTAL
    TRILEPTAL
    74519619 2186101 Live/Registered
    Novartis Corporation
    1994-05-02
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