Products3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Orapred ODT
Product Details
Orapred ODT
Product Details
Orapred ODT
Product Details
Drug Labeling Information
Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
30 mg Carton
Rx only
NDC 59212-702-12
Contents: 2 cards containing 6 tablets
Grape Flavor
Orapred ODT®
(prednisolone sodium phosphate orally disintegrating tablets)
Equivalent to prednisolone 30mg
DESCRIPTION SECTION
11 DESCRIPTION
Orapred ODT (prednisolone sodium phosphate disintegrating tablets) is a sodium salt of the phosphoester of the glucocorticoid prednisolone. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.
Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane.
The chemical name of prednisolone sodium phosphate is pregna-1, 4-diene-3,
20-dione, 11, 17-dihydroxy-21-(phosphonooxy)-, disodium salt, (11ß)-.
The empirical formula is C21H27Na2O8P; the molecular weight is 484.39. Its
chemical structure is:
Each orally disintegrating tablet also contains the following inactive ingredients: citric acid, colloidal silicon dioxide, crospovidone, grape flavor, hypromellose, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, sodium bicarbonate, sucralose, and sucrose.