Mircera
These highlights do not include all the information needed to use MIRCERA safely and effectively. See full prescribing information for MIRCERA. MIRCERA (methoxy polyethylene glycol-epoetin beta) injection, for intravenous or subcutaneous useInitial U.S. Approval: 2007
Approved
Approval ID
22c56f2a-f73c-60e7-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 12, 2023
Manufacturers
FDA
Vifor (International) Inc.
DUNS: 482603065
Products 9
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-401
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 50 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-400
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 30 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-407
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 120 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-402
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 75 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-404
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 150 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-406
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 250 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-408
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 360 ug in 0.6 mL
Code: LR3UXN0193
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-403
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 100 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
Methoxy polyethylene glycol-epoetin beta
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59353-405
Application NumberBLA125164
Product Classification
M
Marketing Category
C73585
G
Generic Name
Methoxy polyethylene glycol-epoetin beta
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateOctober 12, 2023
FDA Product Classification
INGREDIENTS (6)
Methoxy polyethylene glycol-epoetin betaActive
Quantity: 200 ug in 0.3 mL
Code: LR3UXN0193
Classification: ACTIB
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT
sodium sulfate anhydrousInactive
Code: 36KCS0R750
Classification: IACT
mannitolInactive
Code: 3OWL53L36A
Classification: IACT
methionineInactive
Code: AE28F7PNPL
Classification: IACT
poloxamer 188Inactive
Code: LQA7B6G8JG
Classification: IACT