Marinol
These highlights do not include all the information needed to use MARINOL safely and effectively. See full prescribing information for MARINOL. MARINOL (dronabinol) capsules, for oral use, CIII Initial U.S. Approval: 1985
Approved
Approval ID
628f9609-6583-49be-be77-b64cfbc46fd7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2019
Manufacturers
FDA
ThePharmaNetwork, LLC
DUNS: 939435280
Products 3
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 Code53097-569
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2020
FDA Product Classification
INGREDIENTS (7)
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53097-568
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2020
FDA Product Classification
INGREDIENTS (5)
DRONABINOLActive
Quantity: 2.5 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
Dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53097-570
Application NumberNDA018651
Product Classification
M
Marketing Category
C73594
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateApril 8, 2020
FDA Product Classification
INGREDIENTS (7)
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DRONABINOLActive
Quantity: 10 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT