NDC 0093-5031

Tiagabine Hydrochloride

Tiagabine Hydrochloride

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

Product ID0093-5031_06d9ddbb-ffdc-440d-a5c2-3eb994270ce1
NDC0093-5031
Product TypeHuman Prescription Drug
Proprietary NameTiagabine Hydrochloride
Generic NameTiagabine Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-06-03
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020646
Labeler NameTeva Pharmaceuticals USA, Inc.
Substance NameTIAGABINE HYDROCHLORIDE
Active Ingredient Strength4 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 0093-5031-56

30 TABLET, FILM COATED in 1 BOTTLE (0093-5031-56)
Marketing Start Date2016-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0093-5031-56 [00093503156]

Tiagabine Hydrochloride TABLET, FILM COATED
Marketing CategoryNDA AUTHORIZED GENERIC
Application NumberNDA020646
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-07-18

Drug Details

Active Ingredients

IngredientStrength
TIAGABINE HYDROCHLORIDE4 mg/1

OpenFDA Data

SPL SET ID:953ef3cc-e3cb-480f-b9ea-256520fd62b8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299903
  • 1299911
  • 1299909
  • 1299917
    • UPC Code
  • 0300935031569
  • 0300935030562

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    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
    69238-1104Tiagabine HydrochlorideTiagabine Hydrochloride
    69238-1107Tiagabine HydrochlorideTiagabine Hydrochloride
    69238-1105Tiagabine HydrochlorideTiagabine Hydrochloride
    69238-1106Tiagabine HydrochlorideTiagabine Hydrochloride
    63459-402GABITRILTiagabine Hydrochloride
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