Prednisolone
PREDNISOLONE ORAL SOLUTION USP, 15 mg per 5 mL6118Rx only
Approved
Approval ID
2f55df4d-df5a-47c5-a924-4ca4955ff627
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 23, 2014
Manufacturers
FDA
Aidarex Pharmaceuticals LLC
DUNS: 801503249
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code33261-475
Application NumberANDA089081
Product Classification
M
Marketing Category
C73584
G
Generic Name
Prednisolone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 23, 2014
FDA Product Classification
INGREDIENTS (11)
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PREDNISOLONEActive
Quantity: 15 mg in 5 mL
Code: 9PHQ9Y1OLM
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT