NDC 72578-057

Felbamate

Felbamate

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

Product ID72578-057_d66a589d-eb0f-47e6-9d90-da34938b5641
NDC72578-057
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-03-03
Marketing CategoryANDA / ANDA
Application NumberANDA208970
Labeler NameViona Pharmaceuticals 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 Through2023-12-31

Packaging

NDC 72578-057-01

100 TABLET in 1 BOTTLE (72578-057-01)
Marketing Start Date2020-03-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72578-057-06 [72578005706]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-77 [72578005777]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-28 [72578005728]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-30 [72578005730]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-16 [72578005716]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-05 [72578005705]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

NDC 72578-057-01 [72578005701]

Felbamate TABLET
Marketing CategoryANDA
Application NumberANDA208970
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-03-03

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/1

OpenFDA Data

SPL SET ID:96f4357c-720c-4651-b638-7b1181531dc5
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.