NDC 70771-1078

Felbamate

Felbamate

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

Product ID70771-1078_08e06bcb-2d2b-45ce-82c4-fd2b8f5b0fb3
NDC70771-1078
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-08-15
Marketing CategoryANDA / ANDA
Application NumberANDA208970
Labeler NameCadila Healthcare Limited
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 Through2020-12-31

Packaging

NDC 70771-1078-1

100 TABLET in 1 BOTTLE (70771-1078-1)
Marketing Start Date2017-08-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70771-1078-9 [70771107809]

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

NDC 70771-1078-5 [70771107805]

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

NDC 70771-1078-3 [70771107803]

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

NDC 70771-1078-1 [70771107801]

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

NDC 70771-1078-4 [70771107804]

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

NDC 70771-1078-8 [70771107808]

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

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/1

OpenFDA Data

SPL SET ID:efa55cb2-b625-4392-9ddb-0a8ad8ee58c4
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198358
  • 198359
    • UPC Code
  • 0370771107711

    • 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.