Silver Sulfadiazine

Product NDC
76420-208
11-digit product format
764200208
Labeler code
76420
Product ID
76420-208_d9c1d5d3-ee58-76e3-e053-2995a90ae559
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
NDA018578
Marketing category
NDA
Marketing start
2011-05-04
Substance
SILVER SULFADIAZINE
Active strength
10 g/1000g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Silver Sulfadiazine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 g/1000g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW46JY43EJR
Rxcui106351

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-208-25Silver Sulfadiazine25 g in 1 TUBECREAM251
76420-208-50Silver Sulfadiazine50 g in 1 TUBECREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-208SILVER SULFADIAZINE CREAM [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 2 package rows20220309_bee162c3-2627-4f28-9715-11a351d497eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNbee162c3-2627-4f28-9715-11a351d497eb1
106351silver sulfadiazine 10 MG/ML Topical CreamSCDbee162c3-2627-4f28-9715-11a351d497eb1
106351silver sulfadiazine 1 % Topical CreamSYbee162c3-2627-4f28-9715-11a351d497eb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-208-257642002082525 g in 1 TUBE (76420-208-25) 25 g2022-03-090000-00-00NoNoCurrent
76420-208-507642002085050 g in 1 TUBE (76420-208-50) 50 g2022-03-090000-00-00NoNoCurrent