Zorvolex
These highlights do not include all the information needed to use ZORVOLEX safely and effectively. See full prescribing information for ZORVOLEX. ZORVOLEX (diclofenac) capsules, for oral useInitial U.S. Approval: 1988
Approved
Approval ID
dff10e66-a577-451d-ba75-1889458ca833
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 8, 2019
Manufacturers
FDA
Iroko Pharmaceuticals LLC
DUNS: 796831217
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac
PRODUCT DETAILS
NDC Product Code42211-203
Application NumberNDA204592
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 18, 2016
Generic Namediclofenac
INGREDIENTS (12)
DICLOFENACActive
Quantity: 18 mg in 1 1
Code: 144O8QL0L1
Classification: ACTIB
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
diclofenac
PRODUCT DETAILS
NDC Product Code42211-204
Application NumberNDA204592
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMay 18, 2016
Generic Namediclofenac
INGREDIENTS (11)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
DICLOFENACActive
Quantity: 35 mg in 1 1
Code: 144O8QL0L1
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT