FDA.reportPublic FDA data

Avar-e

Product NDC
0178-0470
11-digit product format
001780470
Labeler code
0178
Product ID
0178-0470_47e76b9f-6b33-84fb-e063-6294a90a2913
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; 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-e
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
Rxcui1005834, 1005835

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
0178-0470-02Avar-e1 in 1 CARTONCREAM19
0178-0470-02Avar-e57 g in 1 BOTTLE, PLASTICCREAM579
0178-0470-45Avar-e45 g in 1 TUBECREAM459
0178-0470-45Avar-e1 in 1 CARTONCREAM19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0470-02GM - Gram0178-0470da291fea-58c0-47f0-96b7-6a2710146b0312013-02-13
0178-0470-45GM - Gram0178-04702635dc5d-020e-4d4e-9215-fd1958fdb51512013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0470AVAR-E (SULFACETAMIDE SODIUM, SULFUR) CREAM [MISSION PHARMACAL COMPANY]8Current NDC, Legacy NDC, 4 package rows20230927_ca31ab21-8db5-4a65-ab81-b141d350a1ce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005835Avar 10 % / 5 % Topical CreamPSNca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamPSNca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005835sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical Cream [Avar]SBDca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005834sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Topical CreamSCDca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005835Avar (sulfacetamide sodium 10 % / sulfur 5 % ) Topical CreamSYca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005835Avar-e (10 % / 5 % ) Topical CreamSYca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005835Avar-e Green (10 % / 5 % ) Topical CreamSYca31ab21-8db5-4a65-ab81-b141d350a1ce9
1005834sulfacetamide sodium 10 % / sulfur 5 % Topical CreamSYca31ab21-8db5-4a65-ab81-b141d350a1ce9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0178-0470-02001780470021 BOTTLE, PLASTIC in 1 CARTON (0178-0470-02) / 57 g in 1 BOTTLE, PLASTIC2011-09-150000-00-00NoNoCurrent
0178-0470-450017804704545 g in 1 TUBE45 gHistorical