PREDNISOLONE ACETATE
PREDNISOLONE ACETATE
Approved
Approval ID
96232353-7a98-374d-e053-2a95a90a0569
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2019
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
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 Code72189-055
Application NumberNDA017469
Product Classification
M
Marketing Category
C73594
G
Generic Name
PREDNISOLONE ACETATE
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 30, 2019
FDA Product Classification
INGREDIENTS (10)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
PREDNISOLONE ACETATEActive
Quantity: 10 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT