SODIUM SULFACETAMIDE

Product NDC
44523-613
Requested package NDC
44523-613-06
11-digit product format
445230613
Labeler code
44523
Product ID
44523-613_4839e157-d35d-c2f2-e063-6394a90ae389
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM SULFACETAMIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-07
Substance
SULFACETAMIDE SODIUM
Active strength
100 mg/mL
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SODIUM SULFACETAMIDE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4NRT660KJQInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1006107Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
efde52a6-216d-4ccc-8574-5e3e41ec7e06Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
44523-613-06SODIUM SULFACETAMIDE177 mL in 1 BOTTLE, PLASTICLIQUID1776

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-613-06ML - Milliliter44523-613e9fa23bd-d634-4ea8-9fca-00af98c4ee3712013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
PEG-150 PENTAERYTHRITYL TETRASTEARATEINACTIVE INGREDIENT8L4OOQ76AMSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
PEG-3 DISTEAROYLAMIDOETHYLMONIUM METHOSULFATEINACTIVE INGREDIENT395MHJ5PURSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
PEG-60 ALMOND GLYCERIDESINACTIVE INGREDIENT4Y0E651N0FSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0SODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE (SODIUM SULFACETAMIDE) LIQUID [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-613SODIUM SULFACETAMIDE LIQUID [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20230817_efde52a6-216d-4ccc-8574-5e3e41ec7e06.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SODIUM SULFACETAMIDESODIUM SULFACETAMIDEBioComp Pharma, Inc.efde52a6-216d-4ccc-8574-5e3e41ec7e062026-01-12Warnings, Adverse reactionsExact identifier
ndc (package): 44523-613-06
ndc (product): 44523-613
ndc11 (package): 44523061306

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006107sulfacetamide sodium 10 % Medicated Liquid SoapPSNefde52a6-216d-4ccc-8574-5e3e41ec7e066
1006107sulfacetamide sodium 100 MG/ML Medicated Liquid SoapSCDefde52a6-216d-4ccc-8574-5e3e41ec7e066
1006107sulfacetamide sodium 10 % Medicated Liquid SoapSYefde52a6-216d-4ccc-8574-5e3e41ec7e066

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-613-0644523061306177 mL in 1 BOTTLE, PLASTIC (44523-613-06) 177 ml2011-09-070000-00-00NoNoCurrent