PREDNISOLONE ACETATE

Manufacturing Establishments (1)

Labeler

NuCare Pharmaceuticals,Inc.

DUNS Number

010632300

NDC Product Code

68071-2222

Application Number

NDA017011

Marketing Category

NDA authorized generic (C73605)

Route of Administration

OPHTHALMIC

Effective Date

February 4, 2022

Ingredients

EDETATE DISODIUMInactive

Code: 7FLD91C86KClass: IACT

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

BORIC ACIDInactive

Code: R57ZHV85D4Class: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

SODIUM BISULFITEInactive

Code: TZX5469Z6IClass: IACT

SODIUM CHLORIDEInactive

Code: 451W47IQ8XClass: IACT

SODIUM CITRATEInactive

Code: 1Q73Q2JULRClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

Code: 8B2807733DClass: ACTIBQuantity: 10 mg in 1 mL