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, CIIIInitial U.S. Approval: 1985
Approved
Approval ID
66f36fe0-9808-4b73-a99a-794d86ff0c1c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2019
Manufacturers
FDA
Camber Pharmaceuticals Inc
DUNS: 826774775
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 Code31722-962
Application NumberANDA207421
Product Classification
M
Marketing Category
C73584
G
Generic Name
dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMay 10, 2019
FDA Product Classification
INGREDIENTS (14)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DRONABINOLActive
Quantity: 10 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-961
Application NumberANDA207421
Product Classification
M
Marketing Category
C73584
G
Generic Name
dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMay 10, 2019
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
dronabinol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code31722-960
Application NumberANDA207421
Product Classification
M
Marketing Category
C73584
G
Generic Name
dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateMay 10, 2019
FDA Product Classification
INGREDIENTS (14)
DRONABINOLActive
Quantity: 2.5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT