NDC 0037-0442

Felbatol

Felbamate

Felbatol is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals. The primary component is Felbamate.

Product ID0037-0442_10d334ce-9224-4268-b9c3-b21e72797e6c
NDC0037-0442
Product TypeHuman Prescription Drug
Proprietary NameFelbatol
Generic NameFelbamate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date1993-07-29
Marketing CategoryNDA / NDA
Application NumberNDA020189
Labeler NameMeda Pharmaceuticals
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 Through2022-12-31

Packaging

NDC 0037-0442-17

946 mL in 1 BOTTLE, PLASTIC (0037-0442-17)
Marketing Start Date1993-07-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0037-0442-17 [00037044217]

Felbatol SUSPENSION
Marketing CategoryNDA
Application NumberNDA020189
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1993-07-29
Marketing End Date2021-02-28

NDC 0037-0442-67 [00037044267]

Felbatol SUSPENSION
Marketing CategoryNDA
Application NumberNDA020189
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1993-07-29
Marketing End Date2021-02-28

Drug Details

Active Ingredients

IngredientStrength
FELBAMATE600 mg/5mL

OpenFDA Data

SPL SET ID:2f522701-397a-11de-8a39-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310285
  • 209028
  • 209027
  • 209026
  • 198358
  • 198359
  • Pharmacological Class

    • Anti-epileptic Agent [EPC]
    • Decreased Central Nervous System Disorganized Electrical Activity [PE]

    NDC Crossover Matching brand name "Felbatol" or generic name "Felbamate"

    NDCBrand NameGeneric Name
    0037-0430Felbatolfelbamate
    0037-0431Felbatolfelbamate
    0037-0442Felbatolfelbamate
    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

    Trademark Results [Felbatol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FELBATOL
    FELBATOL
    78206969 not registered Dead/Abandoned
    MedPointe Healthcare Inc.
    2003-01-24
    FELBATOL
    FELBATOL
    74361816 1865149 Live/Registered
    MEDA PHARMACEUTICALS INC.
    1993-02-22
    FELBATOL
    FELBATOL
    74310445 not registered Dead/Abandoned
    Carter-Wallace, Inc.
    1992-08-31
    FELBATOL
    FELBATOL
    74257267 1817334 Live/Registered
    MEDA PHARMACEUTICALS INC.
    1992-03-20

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