NDC 59353-403

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 ID: 59353-403_32f37164-5704-4968-ade2-677c49c31ede
• NDC: 59353-403
• Product Type: Human Prescription Drug
• Proprietary Name: Mircera
• Generic Name: Methoxy Polyethylene Glycol-epoetin Beta
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2014-10-24
• Marketing Category: BLA / BLA
• Application Number: BLA125164
• Labeler Name: Vifor (International) Inc.
• Substance Name: METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
• Active Ingredient Strength: 100 ug/.3mL
• Pharm Classes: Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 59353-403-09

1 SYRINGE, GLASS in 1 CARTON (59353-403-09) > 1 mL in 1 SYRINGE, GLASS

• Marketing Start Date: 2014-10-24
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59353-403-09 [59353040309]

Mircera INJECTION, SOLUTION

• Marketing Category: BLA
• Application Number: BLA125164
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-10-24

Drug Details

Active Ingredients

Ingredient	Strength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA	100 ug/.3mL

OpenFDA Data

• SPL SET ID: 22c56f2a-f73c-60e7-e054-00144ff88e88
• Manufacturer:
  • Vifor (International) Inc.
• UNII:
  • LR3UXN0193
• 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"

NDC	Brand Name	Generic Name
0004-0401	Mircera	Methoxy polyethylene glycol-epoetin beta
0004-0402	Mircera	Methoxy polyethylene glycol-epoetin beta
0004-0403	Mircera	Methoxy polyethylene glycol-epoetin beta
0004-0404	Mircera	Methoxy polyethylene glycol-epoetin beta
0004-0406	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-400	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-401	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-402	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-403	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-404	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-405	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-406	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-407	Mircera	Methoxy polyethylene glycol-epoetin beta
59353-408	Mircera	Methoxy polyethylene glycol-epoetin beta