NDC 42858-867

DRONABINOL

Dronabinol

DRONABINOL is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Rhodes Pharmaceuticals L.p.. The primary component is Dronabinol.

Product ID42858-867_5467a1be-b888-4f7c-9a62-5faf6c977b05
NDC42858-867
Product TypeHuman Prescription Drug
Proprietary NameDRONABINOL
Generic NameDronabinol
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date2018-06-26
Marketing CategoryANDA / ANDA
Application NumberANDA078292
Labeler NameRhodes Pharmaceuticals L.P.
Substance NameDRONABINOL
Active Ingredient Strength3 mg/1
Pharm ClassesCannabinoid [EPC],Cannabinoids [CS]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 42858-867-06

60 CAPSULE in 1 BOTTLE (42858-867-06)
Marketing Start Date2018-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 42858-867-06 [42858086706]

DRONABINOL CAPSULE
Marketing CategoryANDA
Application NumberANDA078292
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-26

Drug Details

Active Ingredients

IngredientStrength
DRONABINOL2.5 mg/1

OpenFDA Data

SPL SET ID:3c06ccda-4819-40f8-b2db-fa294bb8a2fa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197636
  • 197634
  • 197635
  • Pharmacological Class

    • Cannabinoid [EPC]
    • Cannabinoids [CS]
    • Cannabinoid [EPC]
    • Cannabinoids [CS]

    Medicade Reported Pricing

    42858086706 DRONABINOL 2.5 MG CAPSULE

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.