XELJANZ
These highlights do not include all the information needed to use XELJANZ/XELJANZ XR/XELJANZ Oral Solution safely and effectively. See full prescribing information for XELJANZ/XELJANZ XR/XELJANZ Oral Solution. XELJANZ (tofacitinib) tablets, for oral use XELJANZ XR (tofacitinib) extended-release tablets, for oral use XELJANZ (tofacitinib) Oral Solution Initial U.S. Approval: 2012
Approved
Approval ID
68e3d6b2-7838-4d2d-a417-09d919b43e13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 4, 2023
Manufacturers
FDA
U.S. Pharmaceuticals
DUNS: 829076905
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tofacitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-502
Application NumberNDA208246
Product Classification
M
Marketing Category
C73594
G
Generic Name
tofacitinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (17)
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
TOFACITINIB CITRATEActive
Quantity: 22 mg in 1 1
Code: O1FF4DIV0D
Classification: ACTIM
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2 ALUMINUM LAKEInactive
Code: 4AQJ3LG584
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
tofacitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-012
Application NumberNDA203214
Product Classification
M
Marketing Category
C73594
G
Generic Name
tofacitinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (9)
TOFACITINIB CITRATEActive
Quantity: 5 mg in 1 1
Code: O1FF4DIV0D
Classification: ACTIM
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
tofacitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-016
Application NumberNDA203214
Product Classification
M
Marketing Category
C73594
G
Generic Name
tofacitinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (11)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TOFACITINIB CITRATEActive
Quantity: 10 mg in 1 1
Code: O1FF4DIV0D
Classification: ACTIM
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5P
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
tofacitinib
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63539-501
Application NumberNDA208246
Product Classification
M
Marketing Category
C73594
G
Generic Name
tofacitinib
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 4, 2023
FDA Product Classification
INGREDIENTS (15)
TOFACITINIB CITRATEActive
Quantity: 11 mg in 1 1
Code: O1FF4DIV0D
Classification: ACTIM
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE ACETATEInactive
Code: 3J2P07GVB6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671P
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT