FDA.reportPublic FDA data

Silver Sulfadiazine

Product NDC
0440-0124
11-digit product format
004400124
Labeler code
0440
Product ID
0440-0124_83f4743b-bae1-458c-aa2d-c1e0d6c511b3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Liberty 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
E
Listing certified through
2018-12-31
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
0440-0124-052020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent
0440-0124-202020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent
0440-0124-252020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent
0440-0124-402020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent
0440-0124-502020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent
0440-0124-852020-01-31C16284748780-19d75b9d0-163f-f424-e053-dadaa90a57ceSilver Sulfadiazine 1percent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0440-0124-05Silver Sulfadiazine50 g in 1 TUBECREAM503
0440-0124-20Silver Sulfadiazine20 g in 1 TUBECREAM203
0440-0124-25Silver Sulfadiazine25 g in 1 TUBECREAM253
0440-0124-40Silver Sulfadiazine400 g in 1 JARCREAM4003
0440-0124-50Silver Sulfadiazine50 g in 1 JARCREAM503
0440-0124-85Silver Sulfadiazine85 g in 1 TUBECREAM853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0440-0124SILVER SULFADIAZINE CREAM [LIBERTY PHARMACEUTICALS, INC.]3Legacy NDC, 6 package rows20160728_6a162e09-6e46-4fc7-b3b6-19a518ac8307.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN6a162e09-6e46-4fc7-b3b6-19a518ac83073
106351silver sulfadiazine 10 MG/ML Topical CreamSCD6a162e09-6e46-4fc7-b3b6-19a518ac83073
106351silver sulfadiazine 1 % Topical CreamSY6a162e09-6e46-4fc7-b3b6-19a518ac83073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0440-0124-050044001240550 g in 1 TUBE50 gHistorical
0440-0124-200044001242020 g in 1 TUBE20 gHistorical
0440-0124-250044001242525 g in 1 TUBE25 gHistorical
0440-0124-4000440012440400 g in 1 JAR400 gHistorical
0440-0124-500044001245050 g in 1 JAR50 gHistorical
0440-0124-850044001248585 g in 1 TUBE85 gHistorical