NDC 70518-0894

OXCARBAZEPINE

Oxcarbazepine

OXCARBAZEPINE 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 ID70518-0894_602bccf1-4061-c08f-e053-2991aa0a3a3e
NDC70518-0894
Product TypeHuman Prescription Drug
Proprietary NameOXCARBAZEPINE
Generic NameOxcarbazepine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-12-12
Marketing CategoryANDA / ANDA
Application NumberANDA078069
Labeler NameREMEDYREPACK INC.
Substance NameOXCARBAZEPINE
Active Ingredient Strength150 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0894-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0894-0)
Marketing Start Date2017-12-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0894-1 [70518089401]

OXCARBAZEPINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078069
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-09

NDC 70518-0894-2 [70518089402]

OXCARBAZEPINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078069
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-05-15

NDC 70518-0894-0 [70518089400]

OXCARBAZEPINE TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078069
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-12

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE150 mg/1

OpenFDA Data

SPL SET ID:dbef7bb3-94aa-4cb3-a0ae-01b20f806a7e
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312136
  • Pharmacological Class

    • 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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