NDC Code(s) : 52125-515-01
Packager : REMEDYREPACK INC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SOLU-MEDROLmethylprednisolone sodium succinate INJECTION, POWDER, FOR SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52125-515
Route of Administration INTRAMUSCULAR, INTRACAVERNOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE(UNII: LEC9GKY20K)
(METHYLPREDNISOLONE - UNII:X4W7ZR7023) 		METHYLPREDNISOLONE40 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS(UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC(UNII: GR686LBA74)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:52125-515-011 in 1 VIAL Type 0: Not a Combination Product13/02/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 02/13/2013 02/13/2014

PRINCIPAL DISPLAY PANEL

DRUG: SOLU-MEDROL


GENERIC: methylprednisolone sodium succinate


DOSAGE: INJECTION, POWDER, FOR SOLUTION


ADMINSTRATION: INTRAVENOUS


NDC: 52125-515-01


STRENGTH:40 mg


QTY: 1



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