FDA.reportPublic FDA data

Mircera

Product NDC
59353-405
11-digit product format
593530405
Labeler code
59353
Product ID
59353-405_0a85c353-f0fe-4bdb-843e-47264785e209
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methoxy polyethylene glycol-epoetin beta
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Vifor (International) Inc.
Application
BLA125164
Marketing category
BLA
Marketing start
2014-10-24
Substance
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Active strength
200 ug/.3mL
Pharmacologic classes
Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Mircera
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA200 ug/.3mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
LR3UXN0193Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
758159Internal RxNorm lookup
758160Internal RxNorm lookup
758162Internal RxNorm lookup
758164Internal RxNorm lookup
758169Internal RxNorm lookup
804171Internal RxNorm lookup
1591961Internal RxNorm lookup
1591964Internal RxNorm lookup
1591967Internal RxNorm lookup
1591970Internal RxNorm lookup
1591973Internal RxNorm lookup
1591976Internal RxNorm lookup
1792483Internal RxNorm lookup
1792485Internal RxNorm lookup
1792488Internal RxNorm lookup
1792490Internal RxNorm lookup
1792493Internal RxNorm lookup
1792495Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
22c56f2a-f73c-60e7-e054-00144ff88e88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
0370c658-10ce-4fd7-ba45-6b15c201e539Product name120160622
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59353-405-09Mircera1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION19
59353-405-09Mircera1 in 1 CARTONINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59353-405-09ML - Milliliter59353-405800bc814-86b2-4e48-aeef-ebcaf2fe308b12016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETAACTIVE INGREDIENTLR3UXN0193MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETAACTIVE MOIETYLR3UXN0193MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AMIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
METHIONINEINACTIVE INGREDIENTAE28F7PNPLMIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWMIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1
SODIUM SULFATE ANHYDROUSINACTIVE INGREDIENT36KCS0R750MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59353-405MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]9Current NDC, Legacy NDC, 2 package rows20240615_22c56f2a-f73c-60e7-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MirceraMETHOXY POLYETHYLENE GLYCOL-EPOETIN BETAVifor (International) Inc.22c56f2a-f73c-60e7-e054-00144ff88e882026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA125164
ndc (product): 59353-405

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125164Mirceramethoxy polyethylene glycol-epoetin beta351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
758159methoxy polyethylene glycol-epoetin beta 100 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792488methoxy polyethylene glycol-epoetin beta 120 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
758160methoxy polyethylene glycol-epoetin beta 150 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
758162methoxy polyethylene glycol-epoetin beta 200 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
758164methoxy polyethylene glycol-epoetin beta 250 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792483methoxy polyethylene glycol-epoetin beta 30 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792493methoxy polyethylene glycol-epoetin beta 360 MCG in 0.6 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
758169methoxy polyethylene glycol-epoetin beta 50 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
804171methoxy polyethylene glycol-epoetin beta 75 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591967MIRCERA 100 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792490MIRCERA 120 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591970MIRCERA 150 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591973MIRCERA 200 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591976MIRCERA 250 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792485MIRCERA 30 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1792495MIRCERA 360 MCG in 0.6 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591961MIRCERA 50 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
1591964MIRCERA 75 MCG in 0.3 ML Prefilled SyringePSN22c56f2a-f73c-60e7-e054-00144ff88e889
17924850.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919610.3 ML methoxy polyethylene glycol-epoetin beta 0.167 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919640.3 ML methoxy polyethylene glycol-epoetin beta 0.25 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919670.3 ML methoxy polyethylene glycol-epoetin beta 0.333 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
17924900.3 ML methoxy polyethylene glycol-epoetin beta 0.4 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919700.3 ML methoxy polyethylene glycol-epoetin beta 0.5 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919730.3 ML methoxy polyethylene glycol-epoetin beta 0.667 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
15919760.3 ML methoxy polyethylene glycol-epoetin beta 0.833 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
17924950.6 ML methoxy polyethylene glycol-epoetin beta 0.6 MG/ML Prefilled Syringe [Mircera]SBD22c56f2a-f73c-60e7-e054-00144ff88e889
17924830.3 ML methoxy polyethylene glycol-epoetin beta 0.1 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
7581690.3 ML methoxy polyethylene glycol-epoetin beta 0.167 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
8041710.3 ML methoxy polyethylene glycol-epoetin beta 0.25 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
7581590.3 ML methoxy polyethylene glycol-epoetin beta 0.333 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
17924880.3 ML methoxy polyethylene glycol-epoetin beta 0.4 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
7581600.3 ML methoxy polyethylene glycol-epoetin beta 0.5 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
7581620.3 ML methoxy polyethylene glycol-epoetin beta 0.667 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
7581640.3 ML methoxy polyethylene glycol-epoetin beta 0.833 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
17924930.6 ML methoxy polyethylene glycol-epoetin beta 0.6 MG/ML Prefilled SyringeSCD22c56f2a-f73c-60e7-e054-00144ff88e889
1792483methoxy polyethylene glycol-epoetin beta 0.03 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758169methoxy polyethylene glycol-epoetin beta 0.05 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
804171methoxy polyethylene glycol-epoetin beta 0.075 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758159methoxy polyethylene glycol-epoetin beta 0.1 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792488methoxy polyethylene glycol-epoetin beta 0.12 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758160methoxy polyethylene glycol-epoetin beta 0.15 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758162methoxy polyethylene glycol-epoetin beta 0.2 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758164methoxy polyethylene glycol-epoetin beta 0.25 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792493methoxy polyethylene glycol-epoetin beta 0.36 MG per 0.6 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758159methoxy polyethylene glycol-epoetin beta 100 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792488methoxy polyethylene glycol-epoetin beta 120 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758160methoxy polyethylene glycol-epoetin beta 150 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758162methoxy polyethylene glycol-epoetin beta 200 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758164methoxy polyethylene glycol-epoetin beta 250 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792483methoxy polyethylene glycol-epoetin beta 30 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792493methoxy polyethylene glycol-epoetin beta 360 MCG per 0.6 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
758169methoxy polyethylene glycol-epoetin beta 50 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
804171methoxy polyethylene glycol-epoetin beta 75 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792485Mircera 0.03 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591961Mircera 0.05 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591964Mircera 0.075 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591967Mircera 0.1 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792490Mircera 0.12 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591970Mircera 0.15 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591973Mircera 0.2 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591976Mircera 0.25 MG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792495Mircera 0.36 MG per 0.6 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591967Mircera 100 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792490Mircera 120 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591970Mircera 150 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591973Mircera 200 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591976Mircera 250 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792485Mircera 30 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1792495Mircera 360 MCG per 0.6 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591961Mircera 50 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889
1591964Mircera 75 MCG per 0.3 ML Prefilled SyringeSY22c56f2a-f73c-60e7-e054-00144ff88e889

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59353-405-09593530405091 SYRINGE, GLASS in 1 CARTON (59353-405-09) / 1 mL in 1 SYRINGE, GLASS2014-10-240000-00-00NoNoCurrent