Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Proficient Rx LP
Proficient Rx LP
079196022
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisolone Sodium Phosphate
Product Details
NDC Product Code
63187-215Application Number
ANDA076913Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 1, 2021PrednisoloneActive
Code: IV021NXA9JClass: ACTIMQuantity: 15 mg in 5 mL
Corn SyrupInactive
Code: 9G5L16BK6NClass: IACT
DIBASIC POTASSIUM PHOSPHATEInactive
Code: CI71S98N1ZClass: IACT
MethylparabenInactive
Code: A2I8C7HI9TClass: IACT
Potassium Phosphate, MonobasicInactive
Code: 4J9FJ0HL51Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
Edetate DisodiumInactive
Code: 7FLD91C86KClass: IACT
GlycerinInactive
Code: PDC6A3C0OXClass: IACT
Hydroxyethyl Cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5Class: IACT