Prednisolone Sodium Phosphate
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)
Approved
Approval ID
14b7f41b-4df1-42cb-bd1b-c74b28de2670
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2021
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisolone Sodium Phosphate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-215
Application NumberANDA076913
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2021
FDA Product Classification
INGREDIENTS (10)
Prednisolone Sodium PhosphateActive
Quantity: 15 mg in 5 mL
Code: IV021NXA9J
Classification: ACTIM
Corn SyrupInactive
Code: 9G5L16BK6N
Classification: IACT
DIBASIC POTASSIUM PHOSPHATEInactive
Code: CI71S98N1Z
Classification: IACT
MethylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
Potassium Phosphate, MonobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
Edetate DisodiumInactive
Code: 7FLD91C86K
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Hydroxyethyl Cellulose (140 MPA.S at 5%)Inactive
Code: 8136Y38GY5
Classification: IACT