klaron

Generic: sulfacetamide sodium

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name klaron
Generic Name sulfacetamide sodium
Labeler bausch health us, llc
Dosage Form LOTION
Routes
TOPICAL
Active Ingredients

sulfacetamide sodium 100 mg/mL

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 0187-5198
Product ID 0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA019931
Listing Expiration 2026-12-31
Marketing Start 1996-12-23

Pharmacologic Class

Classes
sulfonamide antibacterial [epc] sulfonamides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01875198
Hyphenated Format 0187-5198

Supplemental Identifiers

RxCUI
1006688 1006693
UNII
4NRT660KJQ

Packaging Origin

Original Packager
true

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 klaron (source: ndc)
Generic Name sulfacetamide sodium (source: ndc)
Application Number NDA019931 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0187-5198-04 1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

sulfacetamide sodium (100 mg/mL)

Linked Drug Pages (1)

Klaron ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4dd0038b-2f5d-436c-8a6d-6db44760c37a", "openfda": {"unii": ["4NRT660KJQ"], "rxcui": ["1006688", "1006693"], "spl_set_id": ["66ab38ea-5cea-47be-97f2-486517999fb0"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0187-5198-04", "marketing_start_date": "19961223"}], "brand_name": "Klaron", "product_id": "0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a", "dosage_form": "LOTION", "pharm_class": ["Sulfonamide Antibacterial [EPC]", "Sulfonamides [CS]"], "product_ndc": "0187-5198", "generic_name": "sulfacetamide sodium", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Klaron", "active_ingredients": [{"name": "SULFACETAMIDE SODIUM", "strength": "100 mg/mL"}], "application_number": "NDA019931", "marketing_category": "NDA", "marketing_start_date": "19961223", "listing_expiration_date": "20261231"}