NDC 0115-1746

Felbamate

Felbamate

Felbamate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Impax Generics. The primary component is Felbamate.

Product ID0115-1746_514cea72-d27c-4f6c-8232-ecee781c0036
NDC0115-1746
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-03-06
Marketing End Date2019-08-31
Marketing CategoryANDA / ANDA
Application NumberANDA202284
Labeler NameImpax Generics
Substance NameFELBAMATE
Active Ingredient Strength400 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN

Packaging

NDC 0115-1746-01

100 TABLET in 1 BOTTLE, PLASTIC (0115-1746-01)
Marketing Start Date2017-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0115-1746-01 [00115174601]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA202284
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-03-06
Marketing End Date2019-08-31

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE400 mg/1

OpenFDA Data

SPL SET ID:255768e3-c7a6-476f-a88b-47a830881f46
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198358
  • 198359
  • UPC Code
  • 0301151747012
  • 0301151746015
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Felbamate" or generic name "Felbamate"

    NDCBrand NameGeneric Name
    0115-1746FelbamateFelbamate
    0115-1747FelbamateFelbamate
    0121-0891FelbamateFelbamate
    10135-601FelbamateFelbamate
    10135-602FelbamateFelbamate
    16714-775FelbamateFelbamate
    47781-550Felbamatefelbamate
    47781-551Felbamatefelbamate
    47781-627Felbamatefelbamate
    47781-630Felbamatefelbamate
    51525-0430Felbamatefelbamate
    51525-0431Felbamatefelbamate
    51525-0442Felbamatefelbamate
    51672-4172FelbamateFelbamate
    51672-4185FelbamateFelbamate
    51672-4186FelbamateFelbamate
    53746-734FelbamateFelbamate
    53746-735FelbamateFelbamate
    68151-4474FelbamateFelbamate
    70710-1054FelbamateFelbamate
    70710-1053FelbamateFelbamate
    70771-1078FelbamateFelbamate
    70771-1077FelbamateFelbamate
    62559-731FelbamateFelbamate
    62559-730FelbamateFelbamate
    64720-256FelbamateFelbamate
    65162-734FelbamateFelbamate
    65162-686FelbamateFelbamate
    65162-735FelbamateFelbamate
    66689-825FelbamateFelbamate
    72578-056FelbamateFelbamate
    72578-057FelbamateFelbamate
    63629-1944FelbamateFelbamate
    63629-1937FelbamateFelbamate
    0037-0430Felbatolfelbamate
    0037-0431Felbatolfelbamate
    0037-0442Felbatolfelbamate

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