NDC 53097-568

Marinol

Dronabinol

Marinol is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Thepharmanetwork, Llc. The primary component is Dronabinol.

Product ID53097-568_628f9609-6583-49be-be77-b64cfbc46fd7
NDC53097-568
Product TypeHuman Prescription Drug
Proprietary NameMarinol
Generic NameDronabinol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2017-05-10
Marketing CategoryNDA / NDA
Application NumberNDA018651
Labeler NameThePharmaNetwork, LLC
Substance NameDRONABINOL
Active Ingredient Strength3 mg/1
Pharm ClassesCannabinoid [EPC],Cannabinoids [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 53097-568-60

1 BOTTLE in 1 CARTON (53097-568-60) > 60 CAPSULE in 1 BOTTLE
Marketing Start Date2017-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53097-568-60 [53097056860]

Marinol CAPSULE
Marketing CategoryNDA
Application NumberNDA018651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-10

Drug Details

Active Ingredients

IngredientStrength
DRONABINOL2.5 mg/1

OpenFDA Data

SPL SET ID:628f9609-6583-49be-be77-b64cfbc46fd7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 205641
  • 205642
  • 205645
  • 197636
  • 197634
  • 197635
    • UPC Code
  • 0353097568602
  • 0353097569609
  • 0353097570605

    • Pharmacological Class

    • Cannabinoid [EPC]
    • Cannabinoids [CS]

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

    NDCBrand NameGeneric Name
    0051-0021MarinolDronabinol
    0051-0022MarinolDronabinol
    0051-0023MarinolDronabinol
    53097-570MarinolMarinol
    53097-568MarinolMarinol
    53097-569MarinolMarinol
    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

    Trademark Results [Marinol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MARINOL
    MARINOL
    79975192 not registered Dead/Abandoned
    Lipid Nutrition B.V.
    2009-09-10
    MARINOL
    MARINOL
    79975192 not registered Dead/Abandoned
    Stepan Specialty Products LLC, a Delaware Corporation
    2009-09-10
    MARINOL
    MARINOL
    79074011 4097562 Live/Registered
    Stepan Specialty Products LLC, a Delawar
    2009-09-10
    MARINOL
    MARINOL
    75468992 2492964 Live/Registered
    UNIMED PHARMACEUTICALS, LLC
    1998-04-16
    MARINOL
    MARINOL
    75178350 2296353 Live/Registered
    STEPAN SPECIALTY PRODUCTS, LLC
    1996-10-07
    MARINOL
    MARINOL
    74689638 1976619 Live/Registered
    UNIMED PHARMACEUTICALS, LLC
    1995-06-16
    MARINOL
    MARINOL
    74649147 not registered Dead/Abandoned
    LODERS CROKLAAN B.V.
    1995-03-20
    MARINOL
    MARINOL
    73322693 1225688 Live/Registered
    Unimed, Inc.
    1981-08-07
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