BLEPHAMIDE
BLEPHAMIDE (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%
Approved
Approval ID
24636134-1ca9-4a91-acdf-207b8797570f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 4, 2012
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 Code54868-1157
Application NumberANDA087748
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulfacetamide sodium and prednisolone acetate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 4, 2012
FDA Product Classification
INGREDIENTS (6)
sulfacetamide sodiumActive
Quantity: 100 mg in 1 g
Code: 4NRT660KJQ
Classification: ACTIB
prednisolone acetateActive
Quantity: 2 mg in 1 g
Code: 8B2807733D
Classification: ACTIB
phenylmercuric acetateInactive
Code: OSX88361UX
Classification: IACT
petrolatumInactive
Code: 4T6H12BN9U
Classification: IACT
mineral oilInactive
Code: T5L8T28FGP
Classification: IACT
lanolin alcoholsInactive
Code: 884C3FA9HE
Classification: IACT