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
18cf326f-a5d7-423c-8eff-58057e19cf3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-9166
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2021
FDA Product Classification
INGREDIENTS (5)
DRONABINOLActive
Quantity: 2.5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT