Sulfacetamide Sodium
SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION USP, 10%
Approved
Approval ID
5530fb5f-728b-4a10-a345-01cd749a2684
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2021
Manufacturers
FDA
Sandoz Inc.
DUNS: 005387188
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulfacetamide Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61314-701
Application NumberANDA089560
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfacetamide Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 5, 2011
FDA Product Classification
INGREDIENTS (6)
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
SULFACETAMIDE SODIUMActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
METHYLCELLULOSE (4000 MPA.S)Inactive
Code: MRJ667KA5E
Classification: IACT
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMInactive
Code: 3980JIH2SW
Classification: IACT