NDC 0085-1323

PEGINTRON

Peginterferon Alfa-2b

PEGINTRON is a Subcutaneous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Peginterferon Alfa-2b.

Product ID0085-1323_519a40d2-566f-4d64-8ffb-35813db6c6ae
NDC0085-1323
Product TypeHuman Prescription Drug
Proprietary NamePEGINTRON
Generic NamePeginterferon Alfa-2b
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2001-01-19
Marketing CategoryBLA / BLA
Application NumberBLA103949
Labeler NameMerck Sharp & Dohme Corp.
Substance NamePEGINTERFERON ALFA-2B
Active Ingredient Strength50 ug/.5mL
Pharm ClassesInterferon-alpha [CS],Interferon alpha [EPC],Interferon-alpha [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0085-1323-01

1 CARTRIDGE in 1 CARTON (0085-1323-01) > .5 mL in 1 CARTRIDGE
Marketing Start Date2001-01-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-1323-01 [00085132301]

PEGINTRON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-01-19

NDC 0085-1323-02 [00085132302]

PEGINTRON INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA103949
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2001-01-19

Drug Details

Active Ingredients

IngredientStrength
PEGINTERFERON ALFA-2B50 ug/.5mL

OpenFDA Data

SPL SET ID:b70816bb-913a-467f-acb8-67ef62cf8dac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 731348
  • 790247
  • 760029
  • 760039
  • 731345
  • 805010
  • 805009
  • 805008
  • 731333
  • 731334
  • 790245
  • 284194
  • 284195
  • 284192
  • 284193
  • 805007

    • Pharmacological Class

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

    NDC Crossover Matching brand name "PEGINTRON" or generic name "Peginterferon Alfa-2b"

    NDCBrand NameGeneric Name
    0085-1297PEGINTRONPeginterferon alfa-2b
    0085-1316PEGINTRONPeginterferon alfa-2b
    0085-1323PEGINTRONPeginterferon alfa-2b
    0085-1370PEGINTRONPeginterferon alfa-2b
    0085-4353PEGINTRONpeginterferon alfa-2b
    0085-4354PEGINTRONpeginterferon alfa-2b
    0085-4355PEGINTRONpeginterferon alfa-2b
    0085-4356PEGINTRONpeginterferon alfa-2b
    0085-4347SYLATRONpeginterferon alfa-2b
    0085-4348SYLATRONpeginterferon alfa-2b
    0085-4349SYLATRONpeginterferon alfa-2b

    Trademark Results [PEGINTRON]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    PEGINTRON
    PEGINTRON
    85221895 not registered Dead/Abandoned
    Schering Corporation
    2011-01-20
    PEGINTRON
    PEGINTRON
    78774813 3455413 Dead/Cancelled
    MERCK SHARP & DOHME CORP.
    2005-12-16
    PEGINTRON
    PEGINTRON
    77188056 not registered Dead/Abandoned
    SCHERING CORPORATION
    2007-05-23
    PEGINTRON
    PEGINTRON
    77183242 3676994 Live/Registered
    MERCK SHARP & DOHME CORP.
    2007-05-17
    PEGINTRON
    PEGINTRON
    76520577 3418791 Live/Registered
    MERCK SHARP & DOHME CORP.
    2003-05-27
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