Prednisolone Sodium Phosphate

Product NDC
68788-4046
11-digit product format
687884046
Labeler code
68788
Product ID
68788-4046_7262fc84-3db2-4475-8ae4-6bec4477cb81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Prednisolone Sodium Phosphate
Dosage form
SOLUTION
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203559
Marketing category
ANDA
Marketing start
2025-10-28
Substance
PREDNISOLONE SODIUM PHOSPHATE
Active strength
15 mg/5mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
IV021NXA9JPREDNISOLONE SODIUM PHOSPHATE125-02-0PREDNISOLONE SODIUM PHOSPHATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4046-268788404602237 mL in 1 BOTTLE, PLASTIC (68788-4046-2) 237 ml2025-10-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Prednisolone Sodium Phosphate Oral SolutionPreferred Pharmaceuticals Inc.2025-10-28HUMAN PRESCRIPTION DRUG LABEL1