NDC 70726-0303

TIGLUTIK

Riluzole

TIGLUTIK is a Oral Liquid in the Human Prescription Drug category. It is labeled and distributed by Itf Pharma, Inc.. The primary component is Riluzole.

Product ID70726-0303_67b29266-d9a4-4a83-8f07-f41ec96cb341
NDC70726-0303
Product TypeHuman Prescription Drug
Proprietary NameTIGLUTIK
Generic NameRiluzole
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2018-09-21
Marketing CategoryNDA / NDA
Application NumberNDA209080
Labeler NameItf Pharma, Inc.
Substance NameRILUZOLE
Active Ingredient Strength50 mg/10mL
Pharm ClassesBenzothiazole [EPC],Benzothiazoles [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 70726-0303-2

2 BOTTLE, PLASTIC in 1 CARTON (70726-0303-2) > 300 mL in 1 BOTTLE, PLASTIC (70726-0303-1)
Marketing Start Date2018-09-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70726-0303-2 [70726030302]

TIGLUTIK LIQUID
Marketing CategoryNDA
Application NumberNDA209080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-21
Inactivation Date2020-01-31
Reactivation Date2020-03-12

NDC 70726-0303-1 [70726030301]

TIGLUTIK LIQUID
Marketing CategoryNDA
Application NumberNDA209080
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-21

Drug Details

Active Ingredients

IngredientStrength
RILUZOLE50 mg/10mL

OpenFDA Data

SPL SET ID:75d68f19-4208-109e-e053-2991aa0ac857
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2058147
  • 2059266
  • UPC Code
  • 0370726030323
  • Pharmacological Class

    • Benzothiazole [EPC]
    • Benzothiazoles [CS]

    NDC Crossover Matching brand name "TIGLUTIK" or generic name "Riluzole"

    NDCBrand NameGeneric Name
    70726-0303TIGLUTIKRiluzole
    10094-350EXSERVANriluzole
    70510-2201Exservanriluzole
    70510-2202Exservanriluzole
    70515-700Rilutekriluzole
    0378-4145Riluzoleriluzole
    42291-775Riluzoleriluzole
    60505-3285RILUZOLERILUZOLE
    62756-538RiluzoleRiluzole
    64980-191Riluzoleriluzole
    67877-286RiluzoleRiluzole
    68084-908RILUZOLERILUZOLE
    68462-381riluzoleriluzole
    69076-200Riluzoleriluzole
    69076-611RiluzoleRiluzole

    Trademark Results [TIGLUTIK]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    TIGLUTIK
    TIGLUTIK
    98658037 not registered Live/Pending
    ITALFARMACO S.A.
    2024-07-19
    TIGLUTIK
    TIGLUTIK
    87402684 5764127 Live/Registered
    ITALFARMACO S.A.
    2017-04-07

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