EPKINLY
These highlights do not include all the information needed to use EPKINLY safely and effectively. See full prescribing information for EPKINLY. EPKINLY™ (epcoritamab-bysp) injection, for subcutaneous use Initial U.S. Approval: 2023
Approved
Approval ID
d7836711-b677-412d-bf2d-0f7c8444103a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2023
Manufacturers
FDA
Genmab US, Inc.
DUNS: 014190016
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
epcoritamab-bysp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82705-010
Application NumberBLA761324
Product Classification
M
Marketing Category
C73585
G
Generic Name
epcoritamab-bysp
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (5)
epcoritamabActive
Quantity: 48 mg in 0.8 mL
Code: D6OMY2L0WA
Classification: ACTIB
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
epcoritamab-bysp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82705-002
Application NumberBLA761324
Product Classification
M
Marketing Category
C73585
G
Generic Name
epcoritamab-bysp
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 16, 2023
FDA Product Classification
INGREDIENTS (5)
epcoritamabActive
Quantity: 4 mg in 0.8 mL
Code: D6OMY2L0WA
Classification: ACTIB
acetic acidInactive
Code: Q40Q9N063P
Classification: IACT
sodium acetateInactive
Code: 4550K0SC9B
Classification: IACT
SorbitolInactive
Code: 506T60A25R
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT