Silver Sulfadiazine

Product NDC
80425-0221
11-digit product format
804250221
Labeler code
80425
Product ID
80425-0221_2a9b1617-60ce-f8ce-e063-6294a90ab02c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
NDA018810
Marketing category
NDA
Marketing start
2023-01-12
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
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 mg/g

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
80425-0221-1Silver Sulfadiazine50 g in 1 TUBECREAM503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0221-1GM - Gram80425-0221831fc269-75e7-4c90-bfe2-1445074e785712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0221SILVER SULFADIAZINE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 1 package rows20250102_f1a0f489-0d9e-66c4-e053-2a95a90a063d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNf1a0f489-0d9e-66c4-e053-2a95a90a063d3
106351silver sulfadiazine 10 MG/ML Topical CreamSCDf1a0f489-0d9e-66c4-e053-2a95a90a063d3
106351silver sulfadiazine 1 % Topical CreamSYf1a0f489-0d9e-66c4-e053-2a95a90a063d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0221-18042502210150 g in 1 TUBE (80425-0221-1) 50 g2023-01-12NoNoHistorical