Klaron

Product NDC
0187-5198
11-digit product format
001875198
Labeler code
0187
Product ID
0187-5198_4dd0038b-2f5d-436c-8a6d-6db44760c37a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium
Dosage form
LOTION
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA019931
Marketing category
NDA
Marketing start
1996-12-23
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Klaron
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ
Rxcui1006688, 1006693

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
0304b7d2-7a07-d53b-750f-36012ae6612eProduct name120140508
64c0cc7e-6478-3ca1-8cd7-9a1251d5a3f6Product name120140508
9ae74339-0a3d-82e9-5dd1-88bd2607bd6bProduct name120140508
e44e38a9-2d9e-b0e2-cce9-490554639f3dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0187-5198-04Klaron1 in 1 CARTONLOTION17
0187-5198-04Klaron118 mL in 1 BOTTLE, PLASTICLOTION1187

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0187-5198-04ML - Milliliter0187-5198a007af07-45af-4e79-bbec-c662a93d85a012013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sulfacetamide sodiumACTIVE INGREDIENT4NRT660KJQKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
sulfacetamideACTIVE MOIETY4965G3J0F5KLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
diethanolamineINACTIVE INGREDIENTAZE05TDV2VKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV0KLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
Lauric DiethanolamideINACTIVE INGREDIENTI29I2VHG38KLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9TKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
propylene glycolINACTIVE INGREDIENT6DC9Q167V3KLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
waterINACTIVE INGREDIENT059QF0KO0RKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3
xanthan gumINACTIVE INGREDIENTTTV12P4NEEKLARON (SULFACETAMIDE SODIUM) LOTION [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0187-5198KLARON (SULFACETAMIDE SODIUM) LOTION [BAUSCH HEALTH US, LLC]7Current NDC, Legacy NDC, 2 package rows20200930_66ab38ea-5cea-47be-97f2-486517999fb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006693Klaron 10 % Topical LotionPSN66ab38ea-5cea-47be-97f2-486517999fb07
1006688sulfacetamide sodium 10 % Topical LotionPSN66ab38ea-5cea-47be-97f2-486517999fb07
1006693sulfacetamide sodium 100 MG/ML Topical Lotion [Klaron]SBD66ab38ea-5cea-47be-97f2-486517999fb07
1006688sulfacetamide sodium 100 MG/ML Topical LotionSCD66ab38ea-5cea-47be-97f2-486517999fb07
1006693Klaron (sulfacetamide sodium 10 % ) Topical LotionSY66ab38ea-5cea-47be-97f2-486517999fb07
1006693Klaron 10 % Topical LotionSY66ab38ea-5cea-47be-97f2-486517999fb07
1006693Klaron 100 MG/ML Topical LotionSY66ab38ea-5cea-47be-97f2-486517999fb07
1006688sulfacetamide sodium 10 % Topical LotionSY66ab38ea-5cea-47be-97f2-486517999fb07
1006688sulfacetamide sodium 10 % Topical SuspensionSY66ab38ea-5cea-47be-97f2-486517999fb07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0187-5198-04001875198041 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) / 118 mL in 1 BOTTLE, PLASTIC1996-12-230000-00-00NoNoCurrent