NDC 68151-4235

GABITRIL

Tiagabine Hydrochloride

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

Product ID68151-4235_7c25748c-ffc7-452a-999a-414101b232d4
NDC68151-4235
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 NameCarilion Materials Management
Substance NameTIAGABINE HYDROCHLORIDE
Active Ingredient Strength4 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-4235-3

1 TABLET, FILM COATED in 1 PACKAGE (68151-4235-3)
Marketing Start Date2010-02-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-4235-3 [68151423503]

GABITRIL TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA020646
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-02-08
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
TIAGABINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:72b7f357-8827-4a8b-b55a-01fbce47ae80
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299978
  • 1299917

    • 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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