FDA.reportPublic FDA data

SODIUM SULFACETAMIDE, SULFUR

Product NDC
44523-604
11-digit product format
445230604
Labeler code
44523
Product ID
44523-604_47e82b11-267d-de52-e063-6294a90ac79b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfacetamide sodium, sulfur
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
BioComp Pharma, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-06-04
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 50 mg/g; mg/g
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, SULFUR
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1005856

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
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
44523-604-01SODIUM SULFACETAMIDE, SULFUR30 g in 1 BOTTLE, PLASTICSUSPENSION306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44523-604-01GM - Gram44523-6045ffc82b1-8890-4b21-9af7-3be596fb252e12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE INGREDIENT70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
SULFURACTIVE MOIETY70FD1KFU70SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
ETHYLPARABENINACTIVE INGREDIENT14255EXE39SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZSODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44523-604SODIUM SULFACETAMIDE, SULFUR (SULFACETAMIDE SODIUM, SULFUR) SUSPENSION [BIOCOMP PHARMA, INC.]5Current NDC, Legacy NDC, 1 package rows20231219_56ee0bc8-c58e-4365-86e6-cb7211fe3413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionPSN56ee0bc8-c58e-4365-86e6-cb7211fe34136
1005856sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical LotionSCD56ee0bc8-c58e-4365-86e6-cb7211fe34136
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical LotionSY56ee0bc8-c58e-4365-86e6-cb7211fe34136
1005856sulfacetamide sodium 10 % / sulfur 5 % Topical SuspensionSY56ee0bc8-c58e-4365-86e6-cb7211fe34136

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
44523-604-014452306040130 g in 1 BOTTLE, PLASTIC (44523-604-01) 30 g2011-06-040000-00-00NoNoCurrent