NDC 52536-365

tiagabine hydrochloride

Tiagabine Hydrochloride

tiagabine hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Wilshire Pharmaceuticals, Inc.. The primary component is Tiagabine Hydrochloride.

Product ID52536-365_60ed80ce-3279-41a6-8bdc-7c8545ceaab0
NDC52536-365
Product TypeHuman Prescription Drug
Proprietary Nametiagabine hydrochloride
Generic NameTiagabine Hydrochloride
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2018-06-01
Marketing CategoryANDA / ANDA
Application NumberANDA206857
Labeler NameWilshire Pharmaceuticals, Inc.
Substance NameTIAGABINE HYDROCHLORIDE
Active Ingredient Strength16 mg/1
Pharm ClassesAnti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 52536-365-03

30 TABLET in 1 BOTTLE (52536-365-03)
Marketing Start Date2018-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52536-365-03 [52536036503]

tiagabine hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA206857
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-06-01

Drug Details

Active Ingredients

IngredientStrength
TIAGABINE HYDROCHLORIDE16 mg/1

OpenFDA Data

SPL SET ID:bdbbda2d-2637-4d66-909c-5220c4953993
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299903
  • 1299911
  • 1299909
  • 1299917
    • UPC Code
  • 0352536350037
  • 0352536355032

    • 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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