mircera

Generic: methoxy polyethylene glycol-epoetin beta

Labeler: vifor (international) inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name mircera
Generic Name methoxy polyethylene glycol-epoetin beta
Labeler vifor (international) inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

methoxy polyethylene glycol-epoetin beta 100 ug/.3mL

Manufacturer
Vifor (International) Inc.

Identifiers & Regulatory

Product NDC 59353-403
Product ID 59353-403_24eb3030-78a2-44cc-b150-c09ec0f080af
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125164
Listing Expiration 2026-12-31
Marketing Start 2014-10-24

Pharmacologic Class

Classes
erythropoiesis-stimulating agent [epc] erythropoietin [cs] increased erythroid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59353403
Hyphenated Format 59353-403

Supplemental Identifiers

RxCUI
758159 758160 758162 758164 758169 804171 1591961 1591964 1591967 1591970 1591973 1591976 1792483 1792485 1792488 1792490 1792493 1792495
UNII
LR3UXN0193

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mircera (source: ndc)
Generic Name methoxy polyethylene glycol-epoetin beta (source: ndc)
Application Number BLA125164 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 ug/.3mL
source: ndc
Packaging
  • 1 SYRINGE, GLASS in 1 CARTON (59353-403-09) / 1 mL in 1 SYRINGE, GLASS
source: ndc

Packages (1)

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

Ingredients (1)

methoxy polyethylene glycol-epoetin beta (100 ug/.3mL)

Linked Drug Pages (1)

Mircera ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "24eb3030-78a2-44cc-b150-c09ec0f080af", "openfda": {"unii": ["LR3UXN0193"], "rxcui": ["758159", "758160", "758162", "758164", "758169", "804171", "1591961", "1591964", "1591967", "1591970", "1591973", "1591976", "1792483", "1792485", "1792488", "1792490", "1792493", "1792495"], "spl_set_id": ["22c56f2a-f73c-60e7-e054-00144ff88e88"], "manufacturer_name": ["Vifor (International) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE, GLASS in 1 CARTON (59353-403-09)  / 1 mL in 1 SYRINGE, GLASS", "package_ndc": "59353-403-09", "marketing_start_date": "20141024"}], "brand_name": "Mircera", "product_id": "59353-403_24eb3030-78a2-44cc-b150-c09ec0f080af", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Erythropoiesis-stimulating Agent [EPC]", "Erythropoietin [CS]", "Increased Erythroid Cell Production [PE]"], "product_ndc": "59353-403", "generic_name": "Methoxy polyethylene glycol-epoetin beta", "labeler_name": "Vifor (International) Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mircera", "active_ingredients": [{"name": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA", "strength": "100 ug/.3mL"}], "application_number": "BLA125164", "marketing_category": "BLA", "marketing_start_date": "20141024", "listing_expiration_date": "20261231"}