NDC 63459-402

GABITRIL

Tiagabine Hydrochloride

GABITRIL is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Tiagabine Hydrochloride.

Product ID63459-402_1b04b1ce-d4e1-40c2-b4f6-89742516c55f
NDC63459-402
Product TypeHuman Prescription Drug
Proprietary NameGABITRIL
Generic NameTiagabine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2001-04-01
Marketing CategoryNDA / NDA
Application NumberNDA020646
Labeler NameCephalon, Inc.
Substance NameTIAGABINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 63459-402-30

30 TABLET, FILM COATED in 1 BOTTLE (63459-402-30)
Marketing Start Date2010-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63459-402-01 [63459040201]

GABITRIL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020646
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-04-01
Marketing End Date2011-02-03

NDC 63459-402-30 [63459040230]

GABITRIL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020646
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-08

Drug Details

Active Ingredients

IngredientStrength
TIAGABINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:cf97a72e-951e-a7db-a574-adac12a6b189
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299978
  • 1299909
  • 1299967
  • 1299903
  • 1299911
  • 1299917
  • 1299973
  • 1299971

    • Pharmacological Class

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

    NDC Crossover Matching brand name "GABITRIL" or generic name "Tiagabine Hydrochloride"

    NDCBrand NameGeneric Name
    63459-402GABITRILTiagabine Hydrochloride
    68151-4235GABITRILGABITRIL
    63459-416GABITRILGABITRIL
    63459-404GABITRILGABITRIL
    63459-412GABITRILGABITRIL
    0093-5030Tiagabine HydrochlorideTiagabine Hydrochloride
    0093-5031Tiagabine HydrochlorideTiagabine Hydrochloride
    0093-8072Tiagabine HydrochlorideTiagabine Hydrochloride
    0093-8076Tiagabine HydrochlorideTiagabine Hydrochloride
    16714-151Tiagabine HydrochlorideTiagabine Hydrochloride
    16714-152Tiagabine HydrochlorideTiagabine Hydrochloride
    16714-153Tiagabine HydrochlorideTiagabine Hydrochloride
    16714-154Tiagabine HydrochlorideTiagabine Hydrochloride
    52536-350tiagabine hydrochloridetiagabine hydrochloride
    52536-355tiagabine hydrochloridetiagabine hydrochloride
    52536-360tiagabine hydrochloridetiagabine hydrochloride
    52536-365tiagabine hydrochloridetiagabine hydrochloride
    62756-200TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE
    62756-224TIAGABINE HYDROCHLORIDETIAGABINE HYDROCHLORIDE

    Trademark Results [GABITRIL]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GABITRIL
    GABITRIL
    76356141 2624880 Dead/Cancelled
    Cephalon, Inc.
    2002-01-08
    GABITRIL
    GABITRIL
    76330868 not registered Dead/Abandoned
    Cephalon, Inc.
    2001-10-29
    GABITRIL
    GABITRIL
    75048016 2155299 Live/Registered
    CEPHALON, INC.
    1996-01-24
    GABITRIL
    GABITRIL
    74425952 not registered Dead/Abandoned
    Abbott Laboratories
    1993-08-18
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