FDA.reportPublic FDA data

AVAR

Product NDC
0178-0480
11-digit product format
001780480
Labeler code
0178
Product ID
0178-0480_47e77005-1215-779a-e063-6394a90a5b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
EMULSION
Route
TOPICAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-09-15
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
AVAR
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
Rxcui999613, 1005767

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
0178-0480-08AVAR227 g in 1 BOTTLE, PLASTICEMULSION2277

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0480-08GM - Gram0178-04805496e2b6-b1b0-4924-a39b-13c4e0a22ac212013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
SULFURACTIVE INGREDIENT70FD1KFU70AVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
SULFACETAMIDEACTIVE MOIETY4965G3J0F5AVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
SULFURACTIVE MOIETY70FD1KFU70AVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
ACACIAINACTIVE INGREDIENT5C5403N26OAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
HECTORITEINACTIVE INGREDIENT08X4KI73EZAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3AVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2
WATERINACTIVE INGREDIENT059QF0KO0RAVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0480AVAR (SULFACETAMIDE SODIUM, SULFUR) EMULSION [MISSION PHARMACAL COMPANY]6Current NDC, Legacy NDC, 1 package rows20230831_88e4070f-0538-463d-b9a7-98a4e8979cd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005767AVAR CLEANSER 10 % / 5 % Medicated Liquid SoapPSN88e4070f-0538-463d-b9a7-98a4e8979cd17
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN88e4070f-0538-463d-b9a7-98a4e8979cd17
1005767sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid Soap [Avar]SBD88e4070f-0538-463d-b9a7-98a4e8979cd17
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD88e4070f-0538-463d-b9a7-98a4e8979cd17
1005767Avar (10 % / 5 % ) Medicated Liquid SoapSY88e4070f-0538-463d-b9a7-98a4e8979cd17
1005767Avar (sulfacetamide sodium 10 % / sulfur 5 % ) Medicated Liquid SoapSY88e4070f-0538-463d-b9a7-98a4e8979cd17
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY88e4070f-0538-463d-b9a7-98a4e8979cd17
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY88e4070f-0538-463d-b9a7-98a4e8979cd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0480-0800178048008227 g in 1 BOTTLE, PLASTIC (0178-0480-08) 227 g2011-09-150000-00-00NoNoCurrent