Tivorbex
These highlights do not include all the information needed to use TIVORBEX safely and effectively. See full prescribing information for TIVORBEX . TIVORBEX ( indomethacin ) Capsules , for oral use Initial U.S. Approval: 1965
Approved
Approval ID
04ca474c-798e-43dd-be7a-1b36720e6a3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2018
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.
indomethacin
PRODUCT DETAILS
NDC Product Code42211-201
Application NumberNDA204768
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 20, 2018
Generic Nameindomethacin
INGREDIENTS (11)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
INDOMETHACINActive
Quantity: 20 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
indomethacin
PRODUCT DETAILS
NDC Product Code42211-202
Application NumberNDA204768
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateFebruary 20, 2018
Generic Nameindomethacin
INGREDIENTS (10)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
INDOMETHACINActive
Quantity: 40 mg in 1 1
Code: XXE1CET956
Classification: ACTIB
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
SODIUM STEARYL FUMARATEInactive
Code: 7CV7WJK4UI
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT