NDC 70710-1053

Felbamate

Felbamate

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

Product ID70710-1053_1cefb345-60f6-49be-a166-b394750783ae
NDC70710-1053
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA208970
Labeler NameZydus Pharmaceuticals (USA) 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 Through2020-12-31

Packaging

NDC 70710-1053-3

30 TABLET in 1 BOTTLE (70710-1053-3)
Marketing Start Date2017-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70710-1053-9 [70710105309]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

NDC 70710-1053-5 [70710105305]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

NDC 70710-1053-3 [70710105303]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

NDC 70710-1053-2 [70710105302]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

NDC 70710-1053-1 [70710105301]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

NDC 70710-1053-4 [70710105304]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-08-15
Marketing End Date2020-03-03

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE400 mg/1

OpenFDA Data

SPL SET ID:781a756e-367d-41b7-a149-73a621f29463
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198358
  • 198359

    • 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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