sulfacetamide sodium

Generic: sulfacetamide sodium

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name sulfacetamide sodium
Generic Name sulfacetamide sodium
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

sulfacetamide sodium 100 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-076
Product ID 76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA089560
Listing Expiration 2026-12-31
Marketing Start 2003-03-25

Pharmacologic Class

Classes
sulfonamide antibacterial [epc] sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420076
Hyphenated Format 76420-076

Supplemental Identifiers

RxCUI
1006120
UNII
4NRT660KJQ

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name sulfacetamide sodium (source: ndc)
Generic Name sulfacetamide sodium (source: ndc)
Application Number ANDA089560 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 15 mL in 1 BOTTLE, PLASTIC (76420-076-15)
source: ndc

Packages (1)

76420-076-15 15 mL in 1 BOTTLE, PLASTIC (76420-076-15)

Ingredients (1)

sulfacetamide sodium (100 mg/mL)

Linked Drug Pages (1)

Sulfacetamide Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd", "openfda": {"unii": ["4NRT660KJQ"], "rxcui": ["1006120"], "spl_set_id": ["c4c29e13-8303-4a9a-bb47-d7413eaf2f26"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 mL in 1 BOTTLE, PLASTIC (76420-076-15)", "package_ndc": "76420-076-15", "marketing_start_date": "20200116"}], "brand_name": "Sulfacetamide Sodium", "product_id": "76420-076_ead2d6e4-62f6-3b3c-e053-2a95a90a4ccd", "dosage_form": "SOLUTION", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "76420-076", "generic_name": "Sulfacetamide Sodium", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sulfacetamide Sodium", "active_ingredients": [{"name": "SULFACETAMIDE SODIUM", "strength": "100 mg/mL"}], "application_number": "ANDA089560", "marketing_category": "ANDA", "marketing_start_date": "20030325", "listing_expiration_date": "20261231"}