Prednisolone Sodium Phosphate
(15 mg Prednisolone Base per 5 mL)
Approved
Approval ID
4c507319-8add-4952-8bea-ff77ab17088f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 27, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
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 Code50090-1582
Application NumberANDA076913
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone Sodium Phosphate
Product Specifications
Route of AdministrationORAL
Effective DateJune 14, 2023
FDA Product Classification
INGREDIENTS (10)
PREDNISOLONE SODIUM PHOSPHATEActive
Quantity: 15 mg in 5 mL
Code: IV021NXA9J
Classification: ACTIM
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
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
DIBASIC POTASSIUM PHOSPHATEInactive
Code: CI71S98N1Z
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT