NDC 59353-406

Mircera

Methoxy Polyethylene Glycol-epoetin Beta

Mircera is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Vifor (international) Inc.. The primary component is Methoxy Polyethylene Glycol-epoetin Beta.

Product ID59353-406_32f37164-5704-4968-ade2-677c49c31ede
NDC59353-406
Product TypeHuman Prescription Drug
Proprietary NameMircera
Generic NameMethoxy Polyethylene Glycol-epoetin Beta
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-10-24
Marketing CategoryBLA / BLA
Application NumberBLA125164
Labeler NameVifor (International) Inc.
Substance NameMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Active Ingredient Strength250 ug/.3mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59353-406-09

1 SYRINGE, GLASS in 1 CARTON (59353-406-09) > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2014-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59353-406-09 [59353040609]

Mircera INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125164
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-10-24

Drug Details

Active Ingredients

IngredientStrength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA250 ug/.3mL

OpenFDA Data

SPL SET ID:22c56f2a-f73c-60e7-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 758164
  • 1591970
  • 1792490
  • 1591961
  • 1792485
  • 1792483
  • 1591973
  • 758160
  • 1792495
  • 758162
  • 1591964
  • 758159
  • 1591967
  • 758169
  • 1792493
  • 1792488
  • 1591976
  • 804171
  • Pharmacological Class

    • Erythropoiesis-stimulating Agent [EPC]
    • Erythropoietin [CS]
    • Increased Erythroid Cell Production [PE]

    NDC Crossover Matching brand name "Mircera" or generic name "Methoxy Polyethylene Glycol-epoetin Beta"

    NDCBrand NameGeneric Name
    0004-0401MirceraMethoxy polyethylene glycol-epoetin beta
    0004-0402MirceraMethoxy polyethylene glycol-epoetin beta
    0004-0403MirceraMethoxy polyethylene glycol-epoetin beta
    0004-0404MirceraMethoxy polyethylene glycol-epoetin beta
    0004-0406MirceraMethoxy polyethylene glycol-epoetin beta
    59353-400MirceraMethoxy polyethylene glycol-epoetin beta
    59353-401MirceraMethoxy polyethylene glycol-epoetin beta
    59353-402MirceraMethoxy polyethylene glycol-epoetin beta
    59353-403MirceraMethoxy polyethylene glycol-epoetin beta
    59353-404MirceraMethoxy polyethylene glycol-epoetin beta
    59353-405MirceraMethoxy polyethylene glycol-epoetin beta
    59353-406MirceraMethoxy polyethylene glycol-epoetin beta
    59353-407MirceraMethoxy polyethylene glycol-epoetin beta
    59353-408MirceraMethoxy polyethylene glycol-epoetin beta

    Trademark Results [Mircera]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MIRCERA
    MIRCERA
    88820445 not registered Live/Pending
    Genentech, Inc.
    2020-03-04
    MIRCERA
    MIRCERA
    87146117 not registered Live/Pending
    HOFFMANN-LA ROCHE INC.
    2016-08-22
    MIRCERA
    MIRCERA
    85888871 not registered Dead/Abandoned
    HOFFMANN-LA ROCHE INC.
    2013-03-28
    MIRCERA
    MIRCERA
    78304603 3237894 Dead/Cancelled
    Hoffmann-La Roche Inc.
    2003-09-24

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.