NDC Code(s) : 49349-840-41
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Solu-Medrol Methylprednisolone Sodium Succinate POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49349-840(NDC:0009-0047)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE(UNII: LEC9GKY20K)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE125 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium phosphate, monobasic anhydrous(UNII: KH7I04HPUU)1.6 mg in 1 mL
sodium phosphate, dibasic(UNII: GR686LBA74)17.4 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49349-840-411 mL in 1 VIAL
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 12/19/2011

PRINCIPAL DISPLAY PANEL

DRUG: Solu-Medrol
GENERIC: Methylprednisolone Sodium Succinate
DOSAGE: POWDER, FOR SOLUTION
ADMINSTRATION: INTRAVENOUS
NDC: 49349-840-41
STRENGTH:125 mg
QTY: 1


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