NDC 69238-1107

Tiagabine Hydrochloride

Tiagabine

Tiagabine Hydrochloride is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Tiagabine Hydrochloride.

Product ID69238-1107_012eca85-d949-4fd3-863e-1fac922150b3
NDC69238-1107
Product TypeHuman Prescription Drug
Proprietary NameTiagabine Hydrochloride
Generic NameTiagabine
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-12-08
Marketing CategoryANDA / ANDA
Application NumberANDA208181
Labeler NameAmneal Pharmaceuticals NY LLC
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 Through2023-12-31

Packaging

NDC 69238-1107-3

30 TABLET in 1 BOTTLE (69238-1107-3)
Marketing Start Date2017-12-08
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1107-3 [69238110703]

Tiagabine Hydrochloride TABLET
Marketing CategoryANDA
Application NumberANDA208181
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-12-08

Drug Details

Active Ingredients

IngredientStrength
TIAGABINE HYDROCHLORIDE16 mg/1

OpenFDA Data

SPL SET ID:7036c6df-6527-4701-b484-6b962914b52a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1299903
  • 1299911
  • 1299909
  • 1299917
    • UPC Code
  • 0369238110630
  • 0369238110531
  • 0369238110432
  • 0369238110739

    • 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"

    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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