FDA.reportPublic FDA data

Plexion

Product NDC
57883-404
11-digit product format
578830404
Labeler code
57883
Product ID
57883-404_463d23fc-cb49-0346-e063-6394a90a2df2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM, SULFUR
Dosage form
CLOTH
Route
TOPICAL
Labeler
Brava Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2005-09-01
Marketing end
2027-07-31
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
98; 48 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Plexion

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SULFACETAMIDE SODIUM98 mg/g
SULFUR48 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4NRT660KJQ, 70FD1KFU70
Rxcui1494170, 1494827

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
57883-404-01Plexion4 g in 1 PACKETCLOTH45
57883-404-10Plexion10 in 1 CARTONCLOTH105
57883-404-60Plexion60 in 1 CARTONCLOTH605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57883-404-60EA - Each57883-404190d85af-3db6-458b-95e5-0d0fde17053812014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SULFACETAMIDE SODIUMACTIVE INGREDIENT4NRT660KJQPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE INGREDIENT70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFACETAMIDEACTIVE MOIETY4965G3J0F5PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SULFURACTIVE MOIETY70FD1KFU70PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
GLYCERYL STEARATE SEINACTIVE INGREDIENTFCZ5MH785IPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999RPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
SODIUM THIOSULFATEINACTIVE INGREDIENTHX1032V43MPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57883-404PLEXION (SULFACETAMIDE SODIUM, SULFUR) CLOTH [BRAVA PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20241213_8211c8ec-b501-4ac6-8185-b4b9758cdc1a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494827Plexion 9.8 % / 4.8 % Medicated PadPSN8211c8ec-b501-4ac6-8185-b4b9758cdc1a5
1494170sulfacetamide sodium 9.8 % / sulfur 4.8 % Medicated PadPSN8211c8ec-b501-4ac6-8185-b4b9758cdc1a5
1494827sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Medicated Pad [Plexion]SBD8211c8ec-b501-4ac6-8185-b4b9758cdc1a5
1494170sulfacetamide sodium 98 MG/ML / sulfur 48 MG/ML Medicated PadSCD8211c8ec-b501-4ac6-8185-b4b9758cdc1a5
1494827Plexion (sulfacetamide sodium 9.8 % / sulfur 4.8 % ) Cleansing ClothSY8211c8ec-b501-4ac6-8185-b4b9758cdc1a5
1494170sulfacetamide sodium 9.8 % / sulfur 4.8 % Cleansing ClothSY8211c8ec-b501-4ac6-8185-b4b9758cdc1a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57883-404-01578830404014 g in 1 PACKET4 gHistorical
57883-404-105788304041010 PACKET in 1 CARTON (57883-404-10) / 4 g in 1 PACKET (57883-404-01) 10 packet2005-09-012027-07-31YesNoCurrent
57883-404-605788304046060 PACKET in 1 CARTON (57883-404-60) / 4 g in 1 PACKET (57883-404-01) 60 packet2005-09-012027-07-31NoNoCurrent