NDC 0078-0457

Trileptal

Oxcarbazepine

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

Product ID0078-0457_17f72463-652b-413b-855f-802851310051
NDC0078-0457
Product TypeHuman Prescription Drug
Proprietary NameTrileptal
Generic NameOxcarbazepine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2000-01-30
Marketing CategoryNDA / NDA
Application NumberNDA021014
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameOXCARBAZEPINE
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0457-05

100 TABLET, FILM COATED in 1 BOTTLE (0078-0457-05)
Marketing Start Date2000-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0457-05 [00078045705]

Trileptal TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021014
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-01-30

NDC 0078-0457-61 [00078045761]

Trileptal TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021014
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-03-18

NDC 0078-0457-35 [00078045735]

Trileptal TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA021014
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-01-30

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE600 mg/1

OpenFDA Data

SPL SET ID:4c5c86c8-ab7f-4fcf-bc1b-5a0b1fd0691b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312137
  • 312138
  • 312136
  • 283536
  • 261356
  • 261360
  • 351992
  • 262090
  • Pharmacological Class

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