Methylprednisolone Sodium Succinate
methylPREDNISolone Sodium Succinate for Injection, USP After mixing as directed, contains Benzyl Alcohol.
Approved
Approval ID
c5d22210-73c6-4697-a267-75e243508642
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 2, 2023
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-255
Application NumberANDA040583
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 17, 2020
FDA Product Classification
INGREDIENTS (6)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 17.46 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Quantity: 1.6 mg in 1 mL
Code: KH7I04HPUU
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 25 mg in 1 mL
Code: EWQ57Q8I5X
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 40 mg in 1 mL
Code: LEC9GKY20K
Classification: ACTIM
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-258
Application NumberANDA040583
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 17, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Quantity: 1.6 mg in 2 mL
Code: KH7I04HPUU
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 17.4 mg in 2 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 125 mg in 2 mL
Code: LEC9GKY20K
Classification: ACTIM
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63323-265
Application NumberANDA040612
Product Classification
M
Marketing Category
C73584
G
Generic Name
METHYLPREDNISOLONE SODIUM SUCCINATE
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMarch 17, 2020
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Quantity: 12.8 mg in 16 mL
Code: KH7I04HPUU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 139.2 mg in 16 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 1 g in 16 mL
Code: LEC9GKY20K
Classification: ACTIM