NDC 71335-0978

Oxcarbazepine

Oxcarbazepine

Oxcarbazepine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Oxcarbazepine.

Product ID71335-0978_bffce517-4e62-4c96-b4bf-81b2963d5616
NDC71335-0978
Product TypeHuman Prescription Drug
Proprietary NameOxcarbazepine
Generic NameOxcarbazepine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-10-09
Marketing CategoryANDA / ANDA
Application NumberANDA077802
Labeler NameBryant Ranch Prepack
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 Through2020-12-31

Packaging

NDC 71335-0978-1

30 TABLET, FILM COATED in 1 BOTTLE (71335-0978-1)
Marketing Start Date2014-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0978-4 [71335097804]

Oxcarbazepine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-23

NDC 71335-0978-2 [71335097802]

Oxcarbazepine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-23

NDC 71335-0978-1 [71335097801]

Oxcarbazepine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-23

NDC 71335-0978-3 [71335097803]

Oxcarbazepine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077802
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-01-23

Drug Details

Active Ingredients

IngredientStrength
OXCARBAZEPINE300 mg/1

OpenFDA Data

SPL SET ID:1a89b1ea-fb13-4e73-aa35-46da5bc09c30
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312136
  • 312137
  • 312138

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.