FDA.reportPublic FDA data

Thermazene

Product NDC
53097-101
11-digit product format
530970101
Labeler code
53097
Product ID
53097-101_331af50e-8cf9-46f3-a8db-e76632739c92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
The Pharma Network LLC
Application
NDA018810
Marketing category
NDA
Marketing start
2013-07-01
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
53097-101-052020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-102020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-202020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-252020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-402020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-502020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1
53097-101-852020-01-31C16284748780-19d75b9d0-2caa-f424-e053-dadaa90a57ceb63d13c5-90e0-4de8-a075-795bfe8b91a1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53097-101-05Thermazene50 g in 1 JARCREAM503
53097-101-10Thermazene1000 g in 1 JARCREAM10003
53097-101-20Thermazene20 g in 1 TUBECREAM203
53097-101-25Thermazene25 g in 1 TUBECREAM253
53097-101-40Thermazene400 g in 1 JARCREAM4003
53097-101-50Thermazene50 g in 1 TUBECREAM503
53097-101-85Thermazene85 g in 1 TUBECREAM853

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53097-101-05GM - Gram53097-1011be48834-2b08-4334-92c2-85808f6a7de612013-08-02
53097-101-10GM - Gram53097-101c151f1af-d797-45b5-975d-dd7201b6035712013-08-02
53097-101-20GM - Gram53097-101b52fcb77-2237-408d-96e1-6d73eda4aee212013-08-02
53097-101-40GM - Gram53097-101be629709-9a5c-49f5-9936-f003e19c59a712013-08-02
53097-101-50GM - Gram53097-101d994a147-cc18-4230-bb1c-b0c1a721932912013-08-02
53097-101-85GM - Gram53097-101895552de-1619-47a1-b5bd-a45dda57975212013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
SULFADIAZINEACTIVE MOIETY0N7609K889THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
Isopropyl MyristateINACTIVE INGREDIENT0RE8K4LNJSTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
PetrolatumINACTIVE INGREDIENT4T6H12BN9UTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
Polyoxyl 40 StearateINACTIVE INGREDIENT13A4J4NH9ITHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
Sorbitan MonooleateINACTIVE INGREDIENT06XEA2VD56THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3
WaterINACTIVE INGREDIENT059QF0KO0RTHERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53097-101THERMAZENE (SILVER SULFADIAZINE) CREAM [THE PHARMA NETWORK LLC]3Legacy NDC, 7 package rows20150116_b63d13c5-90e0-4de8-a075-795bfe8b91a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNb63d13c5-90e0-4de8-a075-795bfe8b91a13
208187Thermazene 1 % Topical CreamPSNb63d13c5-90e0-4de8-a075-795bfe8b91a13
208187silver sulfadiazine 10 MG/ML Topical Cream [Thermazene]SBDb63d13c5-90e0-4de8-a075-795bfe8b91a13
106351silver sulfadiazine 10 MG/ML Topical CreamSCDb63d13c5-90e0-4de8-a075-795bfe8b91a13
106351silver sulfadiazine 1 % Topical CreamSYb63d13c5-90e0-4de8-a075-795bfe8b91a13
208187Thermazene 1 % Topical CreamSYb63d13c5-90e0-4de8-a075-795bfe8b91a13
208187Thermazene 10 MG/ML Topical CreamSYb63d13c5-90e0-4de8-a075-795bfe8b91a13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53097-101-055309701010550 g in 1 JAR50 gHistorical
53097-101-10530970101101000 g in 1 JAR1000 gHistorical
53097-101-205309701012020 g in 1 TUBE20 gHistorical
53097-101-255309701012525 g in 1 TUBE25 gHistorical
53097-101-4053097010140400 g in 1 JAR400 gHistorical
53097-101-505309701015050 g in 1 TUBE50 gHistorical
53097-101-855309701018585 g in 1 TUBE85 gHistorical