FDA.reportPublic FDA data

Sulfacetamide Sodium and Sulfur

Product NDC
42582-600
11-digit product format
425820600
Labeler code
42582
Product ID
42582-600_ebe04d90-86e0-4d29-b66e-056771602a40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SULFACETAMIDE SODIUM and SULFUR
Dosage form
CREAM
Route
TOPICAL
Labeler
Bi-Coastal Pharma International LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
SULFACETAMIDE SODIUM; SULFUR
Active strength
100 mg/g; mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42582-600-202024-01-30C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur
42582-600-232024-01-30C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur
42582-600-202020-03-03C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur
42582-600-232020-03-03C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur
42582-600-202020-01-31C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur
42582-600-232020-01-31C16284748780-19d75b9cf-fc1d-f424-e053-dadaa90a57ceSulfacetamide Sodium and Sulfur

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-600-20Sulfacetamide Sodium and Sulfur340 g in 1 BOTTLECREAM3403
42582-600-20Sulfacetamide Sodium and Sulfur1 in 1 CARTONCREAM13
42582-600-23Sulfacetamide Sodium and Sulfur170 g in 1 TUBECREAM1703
42582-600-23Sulfacetamide Sodium and Sulfur1 in 1 CARTONCREAM13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-600-20GM - Gram42582-600356d64bb-ea19-4fe0-8fa6-a54cbbe9c4d812016-02-04
42582-600-23GM - Gram42582-60057cf4314-fa94-43cb-923b-2f8de3dc344d12016-02-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-600SULFACETAMIDE SODIUM AND SULFUR CREAM [BI-COASTAL PHARMA INTERNATIONAL LLC]3Legacy NDC, 4 package rows20220118_6bea7c93-a01b-4a67-a8a1-7779c656d945.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapPSN6bea7c93-a01b-4a67-a8a1-7779c656d9453
999613sulfacetamide sodium 100 MG/ML / sulfur 50 MG/ML Medicated Liquid SoapSCD6bea7c93-a01b-4a67-a8a1-7779c656d9453
999613sulfacetamide sodium 10 % / sulfur 5 % Medicated Liquid SoapSY6bea7c93-a01b-4a67-a8a1-7779c656d9453
999613sulfacetamide sodium 10 % / sulfur 5 % Topical CleanserSY6bea7c93-a01b-4a67-a8a1-7779c656d9453

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-600-20425820600201 BOTTLE in 1 CARTON (42582-600-20) > 340 g in 1 BOTTLE1 bottle2011-01-010000-00-00NoNoCurrent
42582-600-23425820600231 TUBE in 1 CARTON (42582-600-23) > 170 g in 1 TUBE1 tube2011-01-010000-00-00NoNoCurrent