PredniSONE (Page 6 of 6)

HOW SUPPLIED

NDC:68151-0820-8 in a CUP of 1 SOLUTIONS

REFERENCES

Fekety R. Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. . Infectious Diseases
Philadelphia: WBSaunders Company 1992:1050-1.
Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids. 1989:11(6):954-63. Rev Infect Dis

Roxane Laboratories, Inc.

Columbus, Ohio 43216

10002425/06

Revised May 2015

© RLI, 2015

PREDNISONE TABLET PREDNISONE SOLUTION PREDNISONE INTENSOL SOLUTION, CONCENTRATE

Label ImageLabel Image
PREDNISONE
prednisone solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68151-0820(NDC:0054-3722)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISONE (PREDNISONE) PREDNISONE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALCOHOL
CITRIC ACID MONOHYDRATE
EDETATE DISODIUM
FRUCTOSE
HYDROCHLORIC ACID
MALTOL
PEPPERMINT OIL
POLYSORBATE 80
PROPYLENE GLYCOL
SACCHARIN SODIUM
SODIUM BENZOATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68151-0820-8 1 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088703 12/13/1986
Labeler — Carilion Materials Management (079239644)
Registrant — Carilion Materials Management (079239644)
Establishment
Name Address ID/FEI Operations
Carilion Materials Management 079239644 REPACK (68151-0820)

Revised: 05/2015 Carilion Materials Management

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