Bimzelx
These highlights do not include all the information needed to use BIMZELX safely and effectively. See full prescribing information for BIMZELX. BIMZELX® (bimekizumab-bkzx) injection, for subcutaneous use Initial U.S. Approval: 2023
Approved
Approval ID
26b88358-871f-4c80-9d80-b2fb16477f81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2023
Manufacturers
FDA
UCB, Inc.
DUNS: 028526403
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
bimekizumab
PRODUCT DETAILS
NDC Product Code50474-781
Application NumberBLA761151
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 20, 2023
Generic Namebimekizumab
INGREDIENTS (6)
bimekizumabActive
Quantity: 160 mg in 1 mL
Code: 09495UIM6V
Classification: ACTIB
acetic acidInactive
Quantity: 1.23 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
glycineInactive
Quantity: 16.5 mg in 1 mL
Code: TE7660XO1C
Classification: IACT
polysorbate 80Inactive
Quantity: 0.4 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2.83 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
bimekizumab
PRODUCT DETAILS
NDC Product Code50474-780
Application NumberBLA761151
Marketing CategoryC73585
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 20, 2023
Generic Namebimekizumab
INGREDIENTS (6)
polysorbate 80Inactive
Quantity: 0.4 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
bimekizumabActive
Quantity: 160 mg in 1 mL
Code: 09495UIM6V
Classification: ACTIB
acetic acidInactive
Quantity: 1.23 mg in 1 mL
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Quantity: 2.83 mg in 1 mL
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
glycineInactive
Quantity: 16.5 mg in 1 mL
Code: TE7660XO1C
Classification: IACT