Methylprednisolone Sodium Succinate
methylPREDNISolone Sodium Succinate for Injection, USP (Rx only)
Approved
Approval ID
23b17612-b122-4c89-80a7-5f3ca57fad7f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 27, 2021
Manufacturers
FDA
GeneYork Pharmaceuticals Group LLC
DUNS: 080558990
Products 5
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 Code71329-301
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2021
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71329-302
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 125 mg in 2 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 1.84 mg in 2 mL
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 17.4 mg in 2 mL
Code: 22ADO53M6F
Classification: IACT
Methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71329-303
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 69.6 mg in 8 mL
Code: 22ADO53M6F
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 7.36 mg in 8 mL
Code: 593YOG76RN
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 500 mg in 8 mL
Code: LEC9GKY20K
Classification: ACTIM
Methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71329-305
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 2 g in 30.6 mL
Code: LEC9GKY20K
Classification: ACTIM
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 29.44 mg in 30.6 mL
Code: 593YOG76RN
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Quantity: 278 mg in 30.6 mL
Code: 22ADO53M6F
Classification: IACT
Methylprednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71329-304
Application NumberANDA212396
Product Classification
M
Marketing Category
C73584
G
Generic Name
Methylprednisolone
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateApril 27, 2021
FDA Product Classification
INGREDIENTS (3)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive
Quantity: 14.72 mg 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