Prednisolone
Approved
Approval ID
b4f7f1e5-c73d-44ed-8c3e-b1771da678d3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 5, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 2
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 Code54868-4748
Application NumberANDA040423
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisolone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2010
FDA Product Classification
INGREDIENTS (10)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PREDNISOLONEActive
Quantity: 5 mg in 5 mL
Code: 9PHQ9Y1OLM
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCYRRHIZIN, AMMONIATEDInactive
Code: 3VRD35U26C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
prednisolone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4749
Application NumberANDA040323
Product Classification
M
Marketing Category
C73584
G
Generic Name
prednisolone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 5, 2010
FDA Product Classification
INGREDIENTS (14)
PREDNISOLONEActive
Quantity: 15 mg in 5 mL
Code: 9PHQ9Y1OLM
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
GLYCYRRHIZIN, AMMONIATEDInactive
Code: 3VRD35U26C
Classification: IACT
ETHYL MALTOLInactive
Code: L6Q8K29L05
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
D&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
D&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT