Dronabinol
Dronabinol Capsules, USP CIII Rx only
Approved
Approval ID
5050ed63-c6bc-4761-9a81-ef8e5f3f378e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 27, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
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 Code54868-5929
Application NumberANDA078292
Product Classification
M
Marketing Category
C73584
G
Generic Name
Dronabinol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 27, 2012
FDA Product Classification
INGREDIENTS (15)
SESAME OILInactive
Code: QX10HYY4QV
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DRONABINOLActive
Quantity: 5 mg in 1 1
Code: 7J8897W37S
Classification: ACTIB
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT