PREDNISOLONE ACETATE
PREDNISOLONE ACETATE ophthalmic suspension, USP 1% sterile
Approved
Approval ID
ab72cf3d-7660-41b1-e053-2995a90a7f44
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
prednisolone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68071-2222
Application NumberNDA017011
Product Classification
M
Marketing Category
C73605
G
Generic Name
prednisolone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 4, 2022
FDA Product Classification
INGREDIENTS (10)
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM BISULFITEInactive
Code: TZX5469Z6I
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB