NDC 0004-0357

Pegasys

Peginterferon Alfa-2a

Pegasys is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Genentech, Inc.. The primary component is Peginterferon Alfa-2a.

Product ID0004-0357_1c0c1a2c-a7a6-4fde-b801-8e4fda99cfe1
NDC0004-0357
Product TypeHuman Prescription Drug
Proprietary NamePegasys
Generic NamePeginterferon Alfa-2a
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2011-03-29
Marketing CategoryBLA / BLA
Application NumberBLA103964
Labeler NameGenentech, Inc.
Substance NamePEGINTERFERON ALFA-2A
Active Ingredient Strength180 ug/.5mL
Pharm ClassesInterferon alpha [EPC],Interferon-alpha [CS]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 0004-0357-30

1 PACKET in 1 BOX (0004-0357-30) > 4 SYRINGE, GLASS in 1 PACKET > .5 mL in 1 SYRINGE, GLASS
Marketing Start Date2011-03-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0357-99 [00004035799]

Pegasys INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103964
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-29
Marketing End Date2014-09-19

NDC 0004-0357-30 [00004035730]

Pegasys INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA103964
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-03-29

Drug Details

Active Ingredients

IngredientStrength
PEGINTERFERON ALFA-2A180 ug/.5mL

OpenFDA Data

SPL SET ID:de61685e-2b8c-4e22-84bb-869e13600440
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1650940
  • 1650922
  • 351270
  • 352297
  • 1650896
  • 1650894
  • 731326
  • 731328

    • Pharmacological Class

    • Interferon alpha [EPC]
    • Interferon-alpha [CS]

    NDC Crossover Matching brand name "Pegasys" or generic name "Peginterferon Alfa-2a"

    NDCBrand NameGeneric Name
    0004-0350Pegasyspeginterferon alfa-2a
    0004-0357Pegasyspeginterferon alfa-2a
    0004-0365Pegasyspeginterferon alfa-2a
    82154-0449Pegasyspeginterferon alfa-2a
    82154-0451Pegasyspeginterferon alfa-2a

    Trademark Results [Pegasys]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEGASYS
    PEGASYS
    79314220 not registered Live/Pending
    pharma& Schweiz GmbH
    2021-06-02
    PEGASYS
    PEGASYS
    78670857 not registered Dead/Abandoned
    Royal Health Care, LLC
    2005-07-14
    PEGASYS
    PEGASYS
    78175947 2919803 Live/Registered
    Westinghouse Electric Company LLC
    2002-10-18
    PEGASYS
    PEGASYS
    78098505 not registered Dead/Abandoned
    Wysco Products
    2001-12-14
    PEGASYS
    PEGASYS
    77609732 3826867 Live/Registered
    MineWare Pty Ltd
    2008-11-07
    PEGASYS
    PEGASYS
    76106762 2923573 Dead/Cancelled
    Applied Materials, Inc.
    2000-08-08
    PEGASYS
    PEGASYS
    75915681 not registered Dead/Abandoned
    SMITH & WESSON CORP.
    2000-02-10
    PEGASYS
    PEGASYS
    75398703 2355796 Live/Registered
    HOFFMANN-LA ROCHE INC.
    1997-12-02
    PEGASYS
    PEGASYS
    75258497 2139028 Live/Registered
    PEOPLES GAS LIGHT AND COKE COMPANY, THE
    1997-03-17
    PEGASYS
    PEGASYS
    74664513 not registered Dead/Abandoned
    Peoples Gas Light and Coke Company, The
    1995-04-21
    PEGASYS
    PEGASYS
    74525801 2269272 Dead/Cancelled
    Power Measurement Ltd.
    1994-05-17
    PEGASYS
    PEGASYS
    74332802 1790211 Dead/Cancelled
    Engineering Software Research & Development, Inc.
    1992-11-19
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.