NDC 0004-0403

Mircera

Methoxy Polyethylene Glycol-epoetin Beta

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

Product ID0004-0403_2f92af4c-a3cd-46f7-a171-2a90170955b4
NDC0004-0403
Product TypeHuman Prescription Drug
Proprietary NameMircera
Generic NameMethoxy Polyethylene Glycol-epoetin Beta
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-10-24
Marketing End Date2019-07-31
Marketing CategoryBLA / BLA
Application NumberBLA125164
Labeler NameGenentech, Inc.
Substance NameMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Active Ingredient Strength100 ug/.3mL
Pharm ClassesErythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC Exclude FlagN

Packaging

NDC 0004-0403-09

1 SYRINGE, GLASS in 1 CARTON (0004-0403-09) > 1 mL in 1 SYRINGE, GLASS
Marketing Start Date2014-10-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0004-0403-09 [00004040309]

Mircera INJECTION, SOLUTION
Marketing CategoryBLA
Application NumberBLA125164
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-24
Marketing End Date2019-07-31

Drug Details

Active Ingredients

IngredientStrength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA100 ug/.3mL

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

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