Pegasys
These highlights do not include all the information needed to use PEGASYS safely and effectively. See full prescribing information for PEGASYS. PEGASYS® (peginterferon alfa-2a) injection, for subcutaneous use Initial U.S. Approval: 2002
Approved
Approval ID
de61685e-2b8c-4e22-84bb-869e13600440
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2019
Manufacturers
FDA
Genentech, Inc.
DUNS: 080129000
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
peginterferon alfa-2a
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0004-0357
Application NumberBLA103964
Product Classification
M
Marketing Category
C73585
G
Generic Name
peginterferon alfa-2a
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 8, 2019
FDA Product Classification
INGREDIENTS (7)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PEGINTERFERON ALFA-2AActive
Quantity: 180 ug in 0.5 mL
Code: Q46947FE7K
Classification: ACTIB
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
peginterferon alfa-2a
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0004-0350
Application NumberBLA103964
Product Classification
M
Marketing Category
C73585
G
Generic Name
peginterferon alfa-2a
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 8, 2019
FDA Product Classification
INGREDIENTS (7)
PEGINTERFERON ALFA-2AActive
Quantity: 180 ug in 1 mL
Code: Q46947FE7K
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
ACETIC ACIDInactive
Code: Q40Q9N063P
Classification: IACT
SODIUM ACETATEInactive
Code: 4550K0SC9B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT