NDC 61919-569

TRILEPTAL

Oxcarbazepine

TRILEPTAL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Oxcarbazepine.

Product ID61919-569_33af9350-95f4-384e-e054-00144ff88e88
NDC61919-569
Product TypeHuman Prescription Drug
Proprietary NameTRILEPTAL
Generic NameOxcarbazepine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2016-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA077802
Labeler NameDIRECT RX
Substance NameOXCARBAZEPINE
Active Ingredient Strength300 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-569-30

30 TABLET in 1 BOTTLE (61919-569-30)
Marketing Start Date2016-05-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-569-30 [61919056930]

TRILEPTAL TABLET
Marketing CategoryANDA
Application NumberANDA077802
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-05-25

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE300 mg/1

OpenFDA Data

SPL SET ID:33af9350-95f3-384e-e054-00144ff88e88
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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