NDC 0591-3592

Dronabinol

Dronabinol

Dronabinol is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Dronabinol.

Product ID0591-3592_215cd577-6ad9-9a57-b91c-eee6958fe670
NDC0591-3592
Product TypeHuman Prescription Drug
Proprietary NameDronabinol
Generic NameDronabinol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2005-06-07
Marketing End Date2019-05-31
Marketing CategoryNDA / NDA
Application NumberNDA018651
Labeler NameActavis Pharma, Inc.
Substance NameDRONABINOL
Active Ingredient Strength5 mg/1
Pharm ClassesCannabinoid [EPC],Cannabinoids [CS]
DEA ScheduleCIII
NDC Exclude FlagN

Packaging

NDC 0591-3592-60

60 CAPSULE in 1 BOTTLE, PLASTIC (0591-3592-60)
Marketing Start Date2005-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0591-3592-60 [00591359260]

Dronabinol CAPSULE
Marketing CategoryNDA
Application NumberNDA018651
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2005-06-07
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
DRONABINOL5 mg/1

OpenFDA Data

SPL SET ID:1f1af798-17d5-47d0-b129-21d4aa1eb125
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197636
  • 197634
  • 197635
  • Pharmacological Class

    • Cannabinoid [EPC]
    • Cannabinoids [CS]

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

    NDCBrand NameGeneric Name
    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
    67877-569DronabinolDronabinol
    67877-568DronabinolDronabinol
    67877-570DronabinolDronabinol
    68084-174DronabinolDronabinol
    68084-175DronabinolDronabinol
    42858-868DRONABINOLDRONABINOL
    42858-867DRONABINOLDRONABINOL
    42858-869DRONABINOLDRONABINOL
    49884-868DronabinolDronabinol
    49884-867DronabinolDronabinol
    49884-869DronabinolDronabinol
    60687-375DRONABINOLDRONABINOL
    60687-386DRONABINOLDRONABINOL
    31722-960DRONABINOLDRONABINOL
    31722-961DRONABINOLDRONABINOL
    31722-962DRONABINOLDRONABINOL
    42291-451DRONABINOLDRONABINOL
    42291-450DRONABINOLDRONABINOL
    42291-449DRONABINOLDRONABINOL
    0051-0021MarinolDronabinol
    0051-0022MarinolDronabinol
    0051-0023MarinolDronabinol

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