NDC Code(s) : 68791-100-04
Packager : Royal Pharmaceuticals

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

pediapredPREDNISOLONE SODIUM PHOSPHATE SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68791-100
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE SODIUM PHOSPHATE(UNII: IV021NXA9J)
(PREDNISOLONE - UNII:9PHQ9Y1OLM) 		PREDNISOLONE5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM(UNII: 7FLD91C86K)
METHYLPARABEN(UNII: A2I8C7HI9T)
WATER(UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE(UNII: 70WT22SF4B)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE(UNII: 593YOG76RN)
SORBITOL(UNII: 506T60A25R)
Product Characteristics
Color YELLOW (colorless to light straw-colored) Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68791-100-04120 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075183 03/26/2003

PRINCIPAL DISPLAY PANEL

NDC 68791-100-04

Pediapred®

(prednisolone sodium
phosphate)
ORAL SOLUTION
5 mg*/5 mL

*Each 5 mL (teaspoonful) contains: Prednisolone Sodium
Phosphate 6.7 mg equivalent to 5 mg prednisolone.

NONALCOHOLIC, DYE FREE, SUGAR FREE

Rx only

120 mL

Rx Only

ROYAL
PHARMACEUTICALS

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label