Depo-Medrol
DEPO-MEDROL methylprednisolone acetate injectable suspension, USP
Approved
Approval ID
c5ca262e-5558-4065-8ef5-e2e76f3635e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 1, 2012
Manufacturers
FDA
Dispensing Solutions, Inc.
DUNS: 066070785
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
methylprednisolone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55045-3243
Application NumberNDA011757
Product Classification
M
Marketing Category
C73594
G
Generic Name
methylprednisolone acetate
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRASYNOVIAL, INTRALESIONAL, SOFT TISSUE
Effective DateFebruary 1, 2012
FDA Product Classification
INGREDIENTS (9)
methylprednisolone acetateActive
Quantity: 80 mg in 1 mL
Code: 43502P7F0P
Classification: ACTIB
benzyl alcoholInactive
Quantity: 8.88 mg in 1 mL
Code: LKG8494WBH
Classification: IACT
sodium phosphate, dibasicInactive
Quantity: 1.37 mg in 1 mL
Code: GR686LBA74
Classification: IACT
sodium chlorideInactive
Code: 451W47IQ8X
Classification: IACT
sodium phosphate, monobasicInactive
Quantity: 6.59 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
polyethylene glycol 3350Inactive
Quantity: 28.2 mg in 1 mL
Code: G2M7P15E5P
Classification: IACT
polysorbate 80Inactive
Quantity: 1.88 mg in 1 mL
Code: 6OZP39ZG8H
Classification: IACT