NDC 0187-5198

Klaron

Sulfacetamide Sodium

Klaron is a Topical Lotion in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Americas, Inc.. The primary component is Sulfacetamide Sodium.

Product ID0187-5198_099bf71c-85b6-4745-8e2e-9a5eea28d913
NDC0187-5198
Product TypeHuman Prescription Drug
Proprietary NameKlaron
Generic NameSulfacetamide Sodium
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date1996-12-23
Marketing CategoryNDA / NDA
Application NumberNDA019931
Labeler NameBausch Health Americas, Inc.
Substance NameSULFACETAMIDE SODIUM
Active Ingredient Strength100 mg/mL
Pharm ClassesSulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0187-5198-04

1 BOTTLE, PLASTIC in 1 CARTON (0187-5198-04) > 118 mL in 1 BOTTLE, PLASTIC
Marketing Start Date1996-12-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5198-04 [00187519804]

Klaron LOTION
Marketing CategoryNDA
Application NumberNDA019931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1996-12-23

Drug Details

Active Ingredients

IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

OpenFDA Data

SPL SET ID:66ab38ea-5cea-47be-97f2-486517999fb0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1006693
  • 1006688

    • Pharmacological Class

    • Sulfonamide Antibacterial [EPC]
    • Sulfonamides [CS]

    NDC Crossover Matching brand name "Klaron" or generic name "Sulfacetamide Sodium"

    NDCBrand NameGeneric Name
    0187-5198Klaronsulfacetamide sodium
    11980-011BLEPH-10sulfacetamide sodium
    0178-0499OVACESULFACETAMIDE SODIUM
    0178-0620OvaceSULFACETAMIDE SODIUM
    0178-0485OVACE PlusSULFACETAMIDE SODIUM
    0178-0490OVACE PlusSULFACETAMIDE SODIUM
    0178-0495OvacePlusSULFACETAMIDE SODIUM
    44118-712PLEXION NSSULFACETAMIDE SODIUM
    44523-542Sodium Sulfacetamide, SulfurSULFACETAMIDE SODIUM
    0168-0382Sulfacetamide SodiumSulfacetamide Sodium
    0574-4190Sulfacetamide SodiumSulfacetamide Sodium
    17478-221Sulfacetamide SodiumSulfacetamide Sodium
    17478-242Sulfacetamide SodiumSulfacetamide Sodium
    21695-525Sulfacetamide SodiumSulfacetamide Sodium
    24208-670Sulfacetamide Sodiumsulfacetamide sodium
    44523-568SULFACETAMIDE SODIUMSULFACETAMIDE SODIUM
    45802-896Sulfacetamide SodiumSulfacetamide Sodium
    49999-144Sulfacetamide Sodiumsulfacetamide sodium
    50090-0246Sulfacetamide Sodiumsulfacetamide sodium
    51672-1346Sulfacetamide SodiumSulfacetamide Sodium
    52187-553SULFACETAMIDE SODIUMSULFACETAMIDE SODIUM

    Trademark Results [Klaron]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    KLARON
    KLARON
    75214909 2202011 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    1996-12-18
    KLARON
    KLARON
    72137051 0735930 Live/Registered
    Dermik Pharmacal Co., Inc.
    1962-02-01
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