NDC 47781-630

Felbamate

Felbamate

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

Product ID47781-630_25c7b2d5-ed40-22d3-1e48-8e1609ff7c4a
NDC47781-630
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-12-01
Marketing CategoryANDA / ANDA
Application NumberANDA204595
Labeler NameAlvogen Inc.
Substance NameFELBAMATE
Active Ingredient Strength600 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 47781-630-01

100 TABLET in 1 BOTTLE (47781-630-01)
Marketing Start Date2019-01-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 47781-630-01 [47781063001]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA204595
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-01-23

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/1

OpenFDA Data

SPL SET ID:878c4e30-061a-cb63-f84a-c07691708960
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198358
  • 198359
  • 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 "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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