Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Prednisolone
Product Details
NDC Product Code
54868-4748Application Number
ANDA040423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 5, 2010ALCOHOLInactive
Code: 3K9958V90MClass: IACT
PrednisoloneActive
Code: 9PHQ9Y1OLMClass: ACTIBQuantity: 5 mg in 5 mL
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCYRRHIZIN, AMMONIATEDInactive
Code: 3VRD35U26CClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
Prednisolone
Product Details
NDC Product Code
54868-4749Application Number
ANDA040323Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 5, 2010PrednisoloneActive
Code: 9PHQ9Y1OLMClass: ACTIBQuantity: 15 mg in 5 mL
BENZOIC ACIDInactive
Code: 8SKN0B0MIMClass: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QPClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
GLYCYRRHIZIN, AMMONIATEDInactive
Code: 3VRD35U26CClass: IACT
ETHYL MALTOLInactive
Code: L6Q8K29L05Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
D&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
D&C BLUE NO. 1Inactive
Code: H3R47K3TBDClass: IACT