Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Ascent Pharmaceuticals Inc
Camber Pharmaceuticals Inc
080938961
Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
DRONABINOL
Product Details
NDC Product Code
31722-962Application Number
ANDA207421Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 10, 2019PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 10 mg in 1 1
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
DRONABINOL
Product Details
NDC Product Code
31722-961Application Number
ANDA207421Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 10, 2019HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357Class: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 5 mg in 1 1
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
DRONABINOL
Product Details
NDC Product Code
31722-960Application Number
ANDA207421Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
May 10, 2019DronabinolActive
Code: 7J8897W37SClass: ACTIBQuantity: 2.5 mg in 1 1
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62Class: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171KClass: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7UClass: IACT
SESAME OILInactive
Code: QX10HYY4QVClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT