FDA.reportPublic FDA data

Avar-e LS

Product NDC
0178-0465
11-digit product format
001780465
Labeler code
0178
Product ID
0178-0465_3c33097e-a31e-6fd6-e063-6294a90a841b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100; 20 mg/g; mg/g
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
Avar-e LS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM100 mg/g
SULFUR20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1000731, 1000736

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
0178-0465-02Avar-e LS1 in 1 CARTONCREAM19
0178-0465-02Avar-e LS57 g in 1 BOTTLE, PLASTICCREAM579
0178-0465-04Avar-e LS4 g in 1 TUBECREAM49
0178-0465-04Avar-e LS10 in 1 CARTONCREAM109
0178-0465-05Avar-e LS10 in 1 CARTONCREAM109
0178-0465-05Avar-e LS5 g in 1 PACKETCREAM59
0178-0465-45Avar-e LS45 g in 1 TUBECREAM459
0178-0465-45Avar-e LS1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0465-02GM - Gram0178-046585f07c66-730a-4379-96ee-161b0d23fb8212013-02-13
0178-0465-45GM - Gram0178-0465bdd98707-7899-4cd5-9759-9dbec009639412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
SULFURACTIVE INGREDIENT70FD1KFU70AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
SULFACETAMIDEACTIVE MOIETY4965G3J0F5AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
SULFURACTIVE MOIETY70FD1KFU70AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
ACACIAINACTIVE INGREDIENT5C5403N26OAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
ISOSTEARYL PALMITATEINACTIVE INGREDIENT9EHU0R7ER1AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
SODIUM LACTATEINACTIVE INGREDIENTTU7HW0W0QTAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
WATERINACTIVE INGREDIENT059QF0KO0RAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZAVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0465AVAR-E LS (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]8Current NDC, Legacy NDC, 8 package rows20230926_a92edd1d-a7ad-407c-a22c-592ab68f0a74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000736Avar LS (sulfacetamide sodium 10 % / sulfur 2 % ) Topical CreamPSNa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000731sulfacetamide sodium 10 % / sulfur 2 % Topical CreamPSNa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000736sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Topical Cream [Avar]SBDa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000731sulfacetamide sodium 100 MG/ML / sulfur 20 MG/ML Topical CreamSCDa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000736Avar LS (10 % / 2 % ) Topical CreamSYa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000736Avar LS (sulfacetamide sodium 10 % / sulfur 2 % ) Topical CreamSYa92edd1d-a7ad-407c-a22c-592ab68f0a749
1000731sulfacetamide sodium 10 % / sulfur 2 % Topical CreamSYa92edd1d-a7ad-407c-a22c-592ab68f0a749

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0465-020017804650257 g in 1 BOTTLE, PLASTIC (0178-0465-02) 57 g2011-09-150000-00-00NoNoCurrent
0178-0465-040017804650410 TUBE in 1 CARTON (0178-0465-04) / 4 g in 1 TUBE10 tube2011-09-150000-00-00YesNoCurrent
0178-0465-050017804650510 in 1 CARTONHistorical
0178-0465-450017804654545 g in 1 TUBE45 gHistorical