Dronabinol
These highlights do not include all the information needed to use dronabinol capsules safely and effectively. See full prescribing information for dronabinol capsules. Dronabinol capsules, for oral use, CIII Initial U.S. Approval: 1985
Approved
Approval ID
ad8c4bd7-2ab0-437d-a2dc-4714138ed691
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 15, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Dronabinol
PRODUCT DETAILS
NDC Product Code63629-8861
Application NumberNDA018651
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 25, 2021
Generic NameDronabinol
INGREDIENTS (7)
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT