BESREMi
These highlights do not include all the information needed to use BESREMi safely and effectively. See full prescribing information for BESREMi. BESREMI (ropeginterferon alfa-2b-njft) injection, for subcutaneous use Initial U.S. Approval: 2021
Approved
Approval ID
9583405d-53a0-49dc-88eb-5e6384ebabcb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2024
Manufacturers
FDA
PharmaEssentia USA
DUNS: 080514277
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ROPEGINTERFERON ALFA-2B
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code73536-500
Application NumberBLA761166
Product Classification
M
Marketing Category
C73585
G
Generic Name
ROPEGINTERFERON ALFA-2B
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJanuary 12, 2024
FDA Product Classification
INGREDIENTS (7)
BENZYL ALCOHOLInactive
Quantity: 10 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ROPEGINTERFERON ALFA-2BActive
Quantity: 500 ug in 1 mL
Code: 981TME683S
Classification: ACTIB