Methylprednisolone sodium succinate
Approved
Approval ID
738753c7-507d-4881-5194-02dd7597768b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 11, 2022
Manufacturers
FDA
Dr. Reddy's Laboratories Inc
DUNS: 802315887
Products 4
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 Code43598-127
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone sodium succinate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (4)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 40 mg in 1 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.84 mg in 1 mL
Code: 593YOG76RN
Classification: IACT
LACTOSE MONOHYDRATEInactive
Quantity: 25 mg in 1 mL
Code: EWQ57Q8I5X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 17.46 mg in 1 mL
Code: 22ADO53M6F
Classification: IACT
Methylprednisolone sodium succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-129
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone sodium succinate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (3)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 125 mg in 2 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 17.4 mg in 2 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.84 mg in 2 mL
Code: 593YOG76RN
Classification: IACT
Methylprednisolone sodium succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-130
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone sodium succinate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (3)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 14.72 mL in 16 mL
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 139.2 mg in 16 mL
Code: 22ADO53M6F
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 1 g in 16 mL
Code: LEC9GKY20K
Classification: ACTIM
Methylprednisolone sodium succinate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43598-128
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone sodium succinate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 11, 2022
FDA Product Classification
INGREDIENTS (3)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 500 mg in 8 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 7.36 mg in 8 mL
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 69.6 mg in 8 mL
Code: 22ADO53M6F
Classification: IACT