STEQEYMA
These highlights do not include all the information needed to use STEQEYMA safely and effectively. See full prescribing information for STEQEYMA. STEQEYMA (ustekinumab-stba) injection, for subcutaneous or intravenous use Initial U.S. Approval: 2024 STEQEYMA (ustekinumab-stba) is biosimilar to STELARA (ustekinumab)
Approved
Approval ID
66085e17-e3f2-4196-8c81-87448e804b0c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 21, 2025
Manufacturers
FDA
CELLTRION USA Inc.
DUNS: 116587378
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ustekinumab-stba
PRODUCT DETAILS
NDC Product Code72606-027
Application NumberBLA761338
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateApril 21, 2025
Generic Nameustekinumab-stba
INGREDIENTS (6)
ustekinumabActive
Quantity: 45 mg in 0.5 mL
Code: FU77B4U5Z0
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.18 mg in 0.5 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 0.46 mg in 0.5 mL
Code: X573657P6P
Classification: IACT
SucroseInactive
Quantity: 38 mg in 0.5 mL
Code: C151H8M554
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.02 mg in 0.5 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
ustekinumab-stba
PRODUCT DETAILS
NDC Product Code72606-028
Application NumberBLA761338
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateApril 21, 2025
Generic Nameustekinumab-stba
INGREDIENTS (6)
ustekinumabActive
Quantity: 90 mg in 1 mL
Code: FU77B4U5Z0
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.36 mg in 1 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 0.91 mg in 1 mL
Code: X573657P6P
Classification: IACT
SucroseInactive
Quantity: 76 mg in 1 mL
Code: C151H8M554
Classification: IACT
Polysorbate 80Inactive
Quantity: 0.04 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
ustekinumab-stba
PRODUCT DETAILS
NDC Product Code72606-029
Application NumberBLA761338
Marketing CategoryC73585
Route of AdministrationINTRAVENOUS
Effective DateApril 21, 2025
Generic Nameustekinumab-stba
INGREDIENTS (8)
ustekinumabActive
Quantity: 130 mg in 26 mL
Code: FU77B4U5Z0
Classification: ACTIB
HISTIDINEInactive
Quantity: 9.36 mg in 26 mL
Code: 4QD397987E
Classification: IACT
HISTIDINE MONOHYDROCHLORIDE MONOHYDRATEInactive
Quantity: 23.66 mg in 26 mL
Code: X573657P6P
Classification: IACT
Edetate disodiumInactive
Quantity: 0.52 mg in 26 mL
Code: 7FLD91C86K
Classification: IACT
MethionineInactive
Quantity: 10.56 mg in 26 mL
Code: AE28F7PNPL
Classification: IACT
SucroseInactive
Quantity: 1976 mg in 26 mL
Code: C151H8M554
Classification: IACT
Polysorbate 80Inactive
Quantity: 10.37 mg in 26 mL
Code: 6OZP39ZG8H
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT