Prednisolone Sodium Phosphate
PREDNISOLONE SODIUM PHOSPHATE ORAL SOLUTION (15 mg Prednisolone Base per 5 mL)
Approved
Approval ID
06caccd6-07df-4ca5-a5ca-3564bde3192a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2019
Manufacturers
FDA
Unit Dose Services
DUNS: 831995316
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 Code50436-0759
Application NumberANDA076913
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 28, 2018
FDA Product Classification
INGREDIENTS (10)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
DIBASIC POTASSIUM PHOSPHATEInactive
Code: CI71S98N1Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 15 mg in 5 mL
Code: IV021NXA9J
Classification: ACTIM