SOLU-MEDROL
SOLU-MEDROL (methylprednisolone sodium succinate for injection, USP)
Approved
Approval ID
4cc6480c-df7d-0a78-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 9, 2017
Manufacturers
FDA
Sina Health Inc
DUNS: 047161553
Products 1
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 Code70385-2016
Application NumberNDA011856
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone sodium succinate
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 9, 2017
FDA Product Classification
INGREDIENTS (3)
SODIUM PHOSPHATE, DIBASICInactive
Quantity: 17.4 mg in 1 mL
Code: GR686LBA74
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSInactive
Quantity: 1.6 mg in 1 mL
Code: KH7I04HPUU
Classification: IACT
METHYLPREDNISOLONE SODIUM SUCCINATEActive
Quantity: 125 mg in 1 mL
Code: LEC9GKY20K
Classification: ACTIM