FDA.reportPublic FDA data

Mircera

Product NDC
59353-400
11-digit product format
593530400
Labeler code
59353
Product ID
59353-400_24eb3030-78a2-44cc-b150-c09ec0f080af
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
30 ug/.3mL
Pharmacologic classes
Erythropoiesis-stimulating Agent [EPC], Erythropoietin [CS], Increased Erythroid Cell Production [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Mircera
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA30 ug/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiLR3UXN0193
Rxcui758159, 758160, 758162, 758164, 758169, 804171, 1591961, 1591964, 1591967, 1591970, 1591973, 1591976, 1792483, 1792485, 1792488, 1792490, 1792493, 1792495

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
59353-400-09Mircera1 in 1 CARTONINJECTION, SOLUTION19
59353-400-09Mircera1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59353-400-09ML - Milliliter59353-400409233c4-a1c9-4244-9477-31b3b0828ffa12017-03-06

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
59353-400MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.]9Current NDC, Legacy NDC, 2 package rows20240615_22c56f2a-f73c-60e7-e054-00144ff88e88.zip

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
59353-400-09593530400091 SYRINGE, GLASS in 1 CARTON (59353-400-09) / 1 mL in 1 SYRINGE, GLASS2014-10-240000-00-00NoNoCurrent