NDC 68094-123

Oxcarbazepine

Oxcarbazepine

Oxcarbazepine is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Precision Dose, Inc.. The primary component is Oxcarbazepine.

Product ID68094-123_1ac3aa8b-af0b-451e-acd0-e9888da93519
NDC68094-123
Product TypeHuman Prescription Drug
Proprietary NameOxcarbazepine
Generic NameOxcarbazepine
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2017-09-13
Marketing CategoryANDA / ANDA
Application NumberANDA202961
Labeler NamePrecision Dose, Inc.
Substance NameOXCARBAZEPINE
Active Ingredient Strength300 mg/5mL
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68094-123-62

3 TRAY in 1 CASE (68094-123-62) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (68094-123-59)
Marketing Start Date2017-09-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68094-123-62 [68094012362]

Oxcarbazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA202961
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-13

NDC 68094-123-59 [68094012359]

Oxcarbazepine SUSPENSION
Marketing CategoryANDA
Application NumberANDA202961
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-09-13

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE300 mg/5mL

OpenFDA Data

SPL SET ID:636fc847-b3d2-4255-a959-d75499fdb198
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 283536

    • 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 "Oxcarbazepine" or generic name "Oxcarbazepine"

    NDCBrand NameGeneric Name
    0054-0097OxcarbazepineOxcarbazepine
    0054-0098OxcarbazepineOxcarbazepine
    0054-0099OxcarbazepineOxcarbazepine
    0054-0199OxcarbazepineOxcarbazepine
    0615-6593OxcarbazepineOxcarbazepine
    0615-6594OxcarbazepineOxcarbazepine
    0615-6595OxcarbazepineOxcarbazepine
    0615-8153OxcarbazepineOxcarbazepine
    68084-853OxcarbazepineOxcarbazepine
    68094-123OxcarbazepineOxcarbazepine
    68084-867OxcarbazepineOxcarbazepine
    68084-845OxcarbazepineOxcarbazepine
    68462-138OxcarbazepineOxcarbazepine
    68462-139OxcarbazepineOxcarbazepine
    68462-137OxcarbazepineOxcarbazepine
    68788-7306OxcarbazepineOxcarbazepine
    70518-0111OxcarbazepineOxcarbazepine
    70518-1073OxcarbazepineOxcarbazepine
    70518-1027OxcarbazepineOxcarbazepine
    70518-0894OXCARBAZEPINEOXCARBAZEPINE
    70518-1055OxcarbazepineOxcarbazepine
    70518-1980OxcarbazepineOxcarbazepine
    70518-1842OxcarbazepineOxcarbazepine
    71335-0090OXCARBAZEPINEOXCARBAZEPINE
    71335-0410OxcarbazepineOxcarbazepine
    71335-0505OxcarbazepineOxcarbazepine
    71335-0978OxcarbazepineOxcarbazepine
    0781-6270OxcarbazepineOxcarbazepine
    21695-863OxcarbazepineOxcarbazepine
    21695-862OxcarbazepineOxcarbazepine
    21695-864OxcarbazepineOxcarbazepine
    33261-842OxcarbazepineOxcarbazepine
    33261-841OxcarbazepineOxcarbazepine
    33261-684OxcarbazepineOxcarbazepine
    50090-2573OxcarbazepineOxcarbazepine
    50090-3961OxcarbazepineOxcarbazepine
    51672-4105OxcarbazepineOxcarbazepine
    51672-4107OxcarbazepineOxcarbazepine
    51672-4106OxcarbazepineOxcarbazepine
    51991-294OXCARBAZEPINEOXCARBAZEPINE
    51991-293OXCARBAZEPINEOXCARBAZEPINE
    51991-292OXCARBAZEPINEOXCARBAZEPINE
    55154-4959OxcarbazepineOxcarbazepine
    55700-569OxcarbazepineOxcarbazepine
    60429-063OXCARBAZEPINEOXCARBAZEPINE
    60429-062OXCARBAZEPINEOXCARBAZEPINE
    60429-061OXCARBAZEPINEOXCARBAZEPINE
    62756-184OxcarbazepineOxcarbazepine
    62756-183OxcarbazepineOxcarbazepine
    62756-185OxcarbazepineOxcarbazepine
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