Sulfacetamide Sodium
Sulfacetamide SodiumOphthalmic Solution USP, 10%
Approved
Approval ID
f43da9e1-1ed7-48e6-b6f4-4794ba0644a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-525
Application NumberANDA089560
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulfacetamide Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 7, 2005
FDA Product Classification
INGREDIENTS (6)
sulfacetamide sodiumActive
Quantity: 100 mg in 1 mL
Code: 4NRT660KJQ
Classification: ACTIB
sodium thiosulfateInactive
Quantity: 3.1 mg in 1 mL
Code: HX1032V43M
Classification: IACT
propylparabenInactive
Quantity: 0.1 mg in 1 mL
Code: Z8IX2SC1OH
Classification: IACT
methylparabenInactive
Quantity: 0.5 mg in 1 mL
Code: A2I8C7HI9T
Classification: IACT
METHYLCELLULOSE (100 CPS)Inactive
Quantity: 5 mg in 1 mL
Code: 4GFU244C4J
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Quantity: 0.93 mg in 1 mL
Code: 3980JIH2SW
Classification: IACT