DRONABINOL
These highlights do not include all the information needed to use DRONABINOL CAPSULES, USP safely and effectively. See full prescribing information for DRONABINOL CAPSULES, USP. DRONABINOL CAPSULES, USP for oral use, CIII Initial U.S. Approval: 1985
Approved
Approval ID
3c06ccda-4819-40f8-b2db-fa294bb8a2fa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 16, 2023
Manufacturers
FDA
Rhodes Pharmaceuticals L.P.
DUNS: 831928986
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 Code42858-868
Application NumberANDA078292
Product Classification
M
Marketing Category
C73584
G
Generic Name
DRONABINOL
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (15)
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Sesame OilInactive
Code: QX10HYY4QV
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
Butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DRONABINOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-867
Application NumberANDA078292
Product Classification
M
Marketing Category
C73584
G
Generic Name
DRONABINOL
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (15)
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
Gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
DRONABINOLActive
Quantity: 2.5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sesame OilInactive
Code: QX10HYY4QV
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
Isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
Butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C Red No. 40Inactive
Code: WZB9127XOA
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
DRONABINOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42858-869
Application NumberANDA078292
Product Classification
M
Marketing Category
C73584
G
Generic Name
DRONABINOL
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2023
FDA Product Classification
INGREDIENTS (13)
DRONABINOLActive
Quantity: 10 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
Gelatin, unspecifiedInactive
Code: 2G86QN327L
Classification: IACT
FD&C Yellow No. 6Inactive
Code: H77VEI93A8
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sesame OilInactive
Code: QX10HYY4QV
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ShellacInactive
Code: 46N107B71O
Classification: IACT
Isopropyl alcoholInactive
Code: ND2M416302
Classification: IACT
Butyl alcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
Propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT