Prednisolone Sodium Phosphate (Page 5 of 5)

Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL)

Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution (20 mg Prednisolone per 5 mL) contains 26.9 mg Prednisolone sodium phosphate (20 mg Prednisolone base) in a pale to light yellow, grape flavored solution.

NDC 42799-813-01 8 fl oz (237 mL) bottle

Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP.

Store refrigerated at 2°-8°C (36°-46°F)

Keep tightly closed and out of the reach of children.

Manufactured for:
Edenbridge Pharmaceuticals, LLC
Parsippany, NJ 07054
877-381-3336

Rev.12/16

PRINCIPAL DISPLAY PANEL — 10 mg / 5 mL Bottle Label

NDC 42799-812-01

PrednisoLONE
Sodium Phosphate
Oral Solution

Equivalent to prednisolone

10 mg / 5 mL

Store at 20° — 25°C (68° — 77°F).
[See USP Controlled Room Temperature]

ALCOHOL FREE / DYE FREE

8 fl oz (237 mL)
Rx Only

Edenbridge Pharmaceuticals

10
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg / 5 mL Bottle Label

NDC 42799-813-01

PrednisoLONE
Sodium Phosphate
Oral Solution

Equivalent to prednisolone

20 mg / 5 mL

Store refrigerated, 2° — 8°C (36° — 46°F).

ALCOHOL FREE / DYE FREE

8 fl oz (237 mL)
Rx Only

Edenbridge Pharmaceuticals

20
(click image for full-size original)
PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-812
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE 10 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
corn syrup
EDETATE DISODIUM
GLYCERIN
METHYLPARABEN
POTASSIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
WATER
SACCHARIN SODIUM
Product Characteristics
Color YELLOW (pale to light yellow) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-812-01 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203559 11/11/2011
PREDNISOLONE SODIUM PHOSPHATE
prednisolone sodium phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42799-813
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREDNISOLONE SODIUM PHOSPHATE (PREDNISOLONE) PREDNISOLONE 20 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
corn syrup
EDETATE DISODIUM
GLYCERIN
METHYLPARABEN
POTASSIUM PHOSPHATE, DIBASIC
POTASSIUM PHOSPHATE, MONOBASIC
WATER
SACCHARIN SODIUM
Product Characteristics
Color YELLOW (pale to light yellow) Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42799-813-01 237 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203559 11/11/2011
Labeler — Edenbridge Pharmaceuticals LLC. (948715060)

Revised: 02/2022 Edenbridge Pharmaceuticals LLC.

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