Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Patheon Softgels Inc
ThePharmaNetwork, LLC
002193829
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Marinol
Product Details
NDC Product Code
53097-569Application Number
NDA018651Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 8, 2020DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 5 mg in 1 1
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
Marinol
Product Details
NDC Product Code
53097-568Application Number
NDA018651Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 8, 2020DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 2.5 mg in 1 1
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
Marinol
Product Details
NDC Product Code
53097-570Application Number
NDA018651Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
April 8, 2020SESAME OILInactive
Code: QX10HYY4QVClass: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRTClass: IACT
DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 10 mg in 1 1
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT