NDC 10094-210

SYMPAZAN

Clobazam

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

Product ID10094-210_28a44a54-1fa1-4933-aecc-5adcc5df8ca7
NDC10094-210
Product TypeHuman Prescription Drug
Proprietary NameSYMPAZAN
Generic NameClobazam
Dosage FormFilm
Route of AdministrationORAL
Marketing Start Date2018-11-01
Marketing CategoryNDA / NDA
Application NumberNDA210833
Labeler NameAquestive Therapeutics
Substance NameCLOBAZAM
Active Ingredient Strength10 mg/1
Pharm ClassesBenzodiazepine [EPC], Benzodiazepines [CS], Cytochrome P450 2D6 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA]
DEA ScheduleCIV
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 10094-210-60

60 POUCH in 1 PACKAGE (10094-210-60) > 1 FILM in 1 POUCH (10094-210-01)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10094-210-60 [10094021060]

SYMPAZAN FILM
Marketing CategoryNDA
Application NumberNDA210833
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 10094-210-01 [10094021001]

SYMPAZAN FILM
Marketing CategoryNDA
Application NumberNDA210833
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
CLOBAZAM10 mg/1

OpenFDA Data

SPL SET ID:5e3d8fcb-aa7d-4822-88fc-4f06264c3242
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2102715
  • 2102717
  • 2102713
  • 2058253
  • 2058255
  • 2058254
  • Pharmacological Class

    • Benzodiazepine [EPC]
    • Benzodiazepines [CS]
    • Cytochrome P450 2D6 Inhibitors [MoA]
    • Cytochrome P450 3A4 Inducers [MoA]

    NDC Crossover Matching brand name "SYMPAZAN" or generic name "Clobazam"

    NDCBrand NameGeneric Name
    10094-205SYMPAZANclobazam
    10094-210SYMPAZANclobazam
    10094-220SYMPAZANclobazam
    0054-0526ClobazamClobazam
    0054-0527ClobazamClobazam
    0054-0561clobazamclobazam
    0378-8043ClobazamClobazam
    0527-1681Clobazamclobazam
    0527-1682Clobazamclobazam
    0527-5301Clobazamclobazam
    0781-8013ClobazamClobazam
    0781-8014ClobazamClobazam
    0832-0580ClobazamClobazam
    0832-0581ClobazamClobazam
    0832-0585Clobazamclobazam

    Trademark Results [SYMPAZAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYMPAZAN
    SYMPAZAN
    87492332 not registered Live/Pending
    MonoSol Rx, LLC
    2017-06-16

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