SOLU-MEDROL (Page 6 of 6)

PACKAGE LABEL

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SOLU-MEDROL methylprednisolone sodium succinate injection, powder, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61699-0047(NDC:0009-0047)
Route of Administration INTRAVENOUS, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYLPREDNISOLONE SODIUM SUCCINATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE 125 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS 1.6 mg in 1 mL
SODIUM PHOSPHATE, DIBASIC 17.4 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61699-0047-2 1 VIAL in 1 BAG contains a VIAL
1 2 mL in 1 VIAL This package is contained within the BAG (61699-0047-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA011856 07/18/2014
Labeler — US MedSource, LLC (032793851)
Establishment
Name Address ID/FEI Operations
US MedSource, LLC 032793851 repack (61699-0047)

Revised: 07/2014 US MedSource, LLC

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