BLEPHAMIDE
BLEPHAMIDE (sulfacetamide sodium – prednisolone acetate ophthalmic suspension, USP) 10%/0.2%
Approved
Approval ID
69465827-dd70-483e-84c7-ced49af5d189
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 15, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sulfacetamide sodium and prednisolone acetate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-0634
Application NumberNDA012813
Product Classification
M
Marketing Category
C73594
G
Generic Name
sulfacetamide sodium and prednisolone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 15, 2013
FDA Product Classification
INGREDIENTS (12)
edetate disodiumInactive
Code: 7FLD91C86K
Classification: IACT
sulfacetamide sodiumActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
prednisolone acetateActive
Quantity: 2 mg in 1 mL
Code: 8B2807733D
Classification: ACTIB
benzalkonium chlorideInactive
Code: F5UM2KM3W7
Classification: IACT
polyvinyl alcoholInactive
Code: 532B59J990
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
potassium phosphate, monobasicInactive
Code: 4J9FJ0HL51
Classification: IACT
polysorbate 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
sodium phosphate, dibasicInactive
Code: GR686LBA74
Classification: IACT
sodium thiosulfateInactive
Code: HX1032V43M
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT