NDC 20482-335

SYNDROS

Dronabinol

SYNDROS is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Insys Therapeutics, Inc.. The primary component is Dronabinol.

Product ID20482-335_7bcc893e-abb1-48e3-a804-d41554d2a92f
NDC20482-335
Product TypeHuman Prescription Drug
Proprietary NameSYNDROS
Generic NameDronabinol
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-07-27
Marketing CategoryNDA / NDA
Application NumberNDA205525
Labeler NameInsys Therapeutics, Inc.
Substance NameDRONABINOL
Active Ingredient Strength5 mg/mL
Pharm ClassesCannabinoid [EPC],Cannabinoids [CS]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 20482-335-30

1 BOTTLE, GLASS in 1 CARTON (20482-335-30) > 30 mL in 1 BOTTLE, GLASS
Marketing Start Date2017-07-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 20482-335-30 [20482033530]

SYNDROS SOLUTION
Marketing CategoryNDA
Application NumberNDA205525
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-07-27

Drug Details

Active Ingredients

IngredientStrength
DRONABINOL5 mg/mL

OpenFDA Data

SPL SET ID:c2bc83c1-f9fe-11e2-b778-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1928954
  • 1928948
    • UPC Code
  • 0320482335309

    • Pharmacological Class

    • Cannabinoid [EPC]
    • Cannabinoids [CS]

    NDC Crossover Matching brand name "SYNDROS" or generic name "Dronabinol"

    NDCBrand NameGeneric Name
    20482-335SYNDROSSYNDROS
    78613-201SYNDROSSYNDROS
    0527-1450DronabinolDronabinol
    0527-1451DronabinolDronabinol
    0527-1452DronabinolDronabinol
    0527-4125DRONABINOLdronabinol
    0591-3591DronabinolDronabinol
    0591-3592DronabinolDronabinol
    0591-3593DronabinolDronabinol
    0904-6597DronabinolDronabinol
    0904-6598DronabinolDronabinol
    0904-6745DRONABINOLDRONABINOL
    0904-6746DRONABINOLDRONABINOL
    0904-7068DronabinolDronabinol
    0904-7144DronabinolDronabinol
    0904-7145DronabinolDronabinol
    17478-761DronabinolDronabinol
    17478-762DronabinolDronabinol
    17478-763DronabinolDronabinol
    0051-0021MarinolDronabinol
    0051-0022MarinolDronabinol
    0051-0023MarinolDronabinol

    Trademark Results [SYNDROS]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    SYNDROS
    SYNDROS
    86360360 5286618 Live/Registered
    FRESH CUT DEVELOPMENT, LLC
    2014-08-07
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.