Penpulimab
These highlights do not include all the information needed to use PENPULIMAB-KCQX safely and effectively. See full prescribing information for PENPULIMAB-KCQX. PENPULIMAB-KCQX injection, for intravenous use Initial U.S. Approval: 2025
Approved
Approval ID
830004e8-31af-4cc6-ab16-e870cab1c5ca
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 24, 2025
Manufacturers
FDA
Akeso Biopharma, Co., Ltd
DUNS: 544314741
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Penpulimab
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code83654-105
Application NumberBLA761258
Product Classification
M
Marketing Category
C73585
G
Generic Name
Penpulimab
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateApril 24, 2025
FDA Product Classification
INGREDIENTS (5)
ACETIC ACIDInactive
Quantity: 0.9 mg in 10 mL
Code: Q40Q9N063P
Classification: IACT
SORBITOLInactive
Quantity: 450 mg in 10 mL
Code: 506T60A25R
Classification: IACT
SODIUM ACETATEInactive
Quantity: 25.2 mg in 10 mL
Code: 4550K0SC9B
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 2 mg in 10 mL
Code: 6OZP39ZG8H
Classification: IACT
PENPULIMABActive
Quantity: 100 mg in 10 mL
Code: IBS1BZ4E4I
Classification: ACTIM