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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42211-201
Application NumberNDA204768
Product Classification
M
Marketing Category
C73594
G
Generic Name
indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2018
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42211-202
Application NumberNDA204768
Product Classification
M
Marketing Category
C73594
G
Generic Name
indomethacin
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 20, 2018
FDA Product Classification
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