NDC 10094-350

EXSERVAN

Riluzole

EXSERVAN is a Oral Film in the Human Prescription Drug category. It is labeled and distributed by Aquestive Therapeutics. The primary component is Riluzole.

Product ID10094-350_2214fe05-3eae-4b7e-b9d9-70c388ae7500
NDC10094-350
Product TypeHuman Prescription Drug
Proprietary NameEXSERVAN
Generic NameRiluzole
Dosage FormFilm
Route of AdministrationORAL
Marketing Start Date2019-01-24
Marketing CategoryNDA / NDA
Application NumberNDA212640
Labeler NameAquestive Therapeutics
Substance NameRILUZOLE
Active Ingredient Strength50 mg/1
Pharm ClassesBenzothiazole [EPC],Benzothiazoles [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 10094-350-60

50 POUCH in 1 CARTON (10094-350-60) > 1 FILM in 1 POUCH
Marketing Start Date2019-01-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10094-350-60 [10094035060]

EXSERVAN FILM
Marketing CategoryNDA
Application NumberNDA212640
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-01-24

Drug Details

Active Ingredients

IngredientStrength
RILUZOLE50 mg/1

OpenFDA Data

SPL SET ID:0a4ad0db-ce67-4724-91d2-88258c2cc9f8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2265862
  • 2267572
  • Pharmacological Class

    • Benzothiazole [EPC]
    • Benzothiazoles [CS]

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

    NDCBrand NameGeneric Name
    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
    70726-0303TIGLUTIKRiluzole

    Trademark Results [EXSERVAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EXSERVAN
    EXSERVAN
    90792818 not registered Live/Pending
    Aquestive Therapeutics, Inc.
    2021-06-24
    EXSERVAN
    EXSERVAN
    90303402 not registered Live/Pending
    AQUESTIVE THERAPEUTICS, INC.
    2020-11-06
    EXSERVAN
    EXSERVAN
    87512075 not registered Live/Pending
    AQUESTIVE THERAPEUTICS, INC.
    2017-06-30

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