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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50474-781
Application NumberBLA761151
Product Classification
M
Marketing Category
C73585
G
Generic Name
bimekizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 20, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50474-780
Application NumberBLA761151
Product Classification
M
Marketing Category
C73585
G
Generic Name
bimekizumab
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 20, 2023
FDA Product Classification
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