NDC 10135-601

Felbamate

Felbamate

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

Product ID10135-601_247f89ef-aefa-4eac-bb2c-bc6257880305
NDC10135-601
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA201680
Labeler NameMarlex Pharmaceuticals Inc
Substance NameFELBAMATE
Active Ingredient Strength400 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 10135-601-90

90 TABLET in 1 BOTTLE (10135-601-90)
Marketing Start Date2015-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-601-90 [10135060190]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA201680
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-08-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE400 mg/1

OpenFDA Data

SPL SET ID:0a82bcc3-0420-45f5-8c5c-44ab378b4ff3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198358
  • 198359
  • UPC Code
  • 0310135601905
  • 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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