Silver Sulfadiazine

Product NDC
53002-9090
11-digit product format
530029090
Labeler code
53002
Product ID
53002-9090_ee8028bf-fc86-42b2-b8ab-0290c14fe6c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA018810
Marketing category
NDA
Marketing start
1985-12-23
Marketing end
0000-00-00
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
52d15095-bb55-0cfb-f7b0-5be5a913b7dbProduct name120140508
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-9090-12025-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-22025-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-32025-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-12023-06-07C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-22023-06-07C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-32023-06-07C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-12023-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-22023-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-32023-01-30C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-12020-12-17C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-22020-12-17C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-32020-12-17C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-12020-01-31C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-22020-01-31C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685
53002-9090-32020-01-31C16284748780-19d75b9cf-ebee-f424-e053-dadaa90a57cec148ead0-aee5-4d47-a9ba-5b549016a685

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-9090-1Silver Sulfadiazine25 g in 1 TUBECREAM255
53002-9090-2Silver Sulfadiazine50 g in 1 TUBECREAM505
53002-9090-3Silver Sulfadiazine85 g in 1 TUBECREAM855

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-9090SILVER SULFADIAZINE CREAM [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 3 package rows20230609_c148ead0-aee5-4d47-a9ba-5b549016a685.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNc148ead0-aee5-4d47-a9ba-5b549016a6855
106351silver sulfadiazine 10 MG/ML Topical CreamSCDc148ead0-aee5-4d47-a9ba-5b549016a6855
106351silver sulfadiazine 1 % Topical CreamSYc148ead0-aee5-4d47-a9ba-5b549016a6855

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-9090-15300290900125 g in 1 TUBE (53002-9090-1) 25 g2017-10-010000-00-00NoNoCurrent
53002-9090-25300290900250 g in 1 TUBE (53002-9090-2) 50 g2017-10-010000-00-00NoNoCurrent
53002-9090-35300290900385 g in 1 TUBE (53002-9090-3) 85 g2017-10-010000-00-00NoNoCurrent