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
fd8c5d57-0173-4f62-8ff0-d8147986a976
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 2
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 Code0904-7144
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (5)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DRONABINOLActive
Quantity: 2.5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
Dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-7145
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2021
FDA Product Classification
INGREDIENTS (7)
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT