Methylprednisolone Sodium Succinate
Methylprednisolone Sodium Succinate for Injection, USP Rx only
Approved
Approval ID
e86fbda8-00e4-4d54-841a-59dea6c15e70
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 25, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 827748190
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1000
Application NumberANDA207549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (5)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 40 mg in 1 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
Methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70121-1001
Application NumberANDA207549
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateDecember 25, 2023
FDA Product Classification
INGREDIENTS (4)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 125 mg in 2 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT