NDC 66689-825

Felbamate

Felbamate

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

Product ID66689-825_205cd342-842b-47d8-982b-df01df2aeab1
NDC66689-825
Product TypeHuman Prescription Drug
Proprietary NameFelbamate
Generic NameFelbamate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA211333
Labeler NameVistaPharm, Inc.
Substance NameFELBAMATE
Active Ingredient Strength600 mg/5mL
Pharm ClassesAnti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 66689-825-08

237 mL in 1 BOTTLE, PLASTIC (66689-825-08)
Marketing Start Date2019-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66689-825-08 [66689082508]

Felbamate SUSPENSION
Marketing CategoryANDA
Application NumberANDA211333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-06-24

NDC 66689-825-16 [66689082516]

Felbamate SUSPENSION
Marketing CategoryANDA
Application NumberANDA211333
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-28

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/5mL

OpenFDA Data

SPL SET ID:61b87f0f-ae0b-42ee-adc9-16ce2ba96684
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310285
  • 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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