Silver Sulfadiazine

Product NDC
87063-078
11-digit product format
870630078
Labeler code
87063
Product ID
87063-078_4908298d-e389-9450-e063-6394a90a5e75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Asclemed USA, Inc.
Application
NDA018810
Marketing category
NDA
Marketing start
1985-12-23
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Silver Sulfadiazine
Listing expiration
2027-12-31

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
87063-078-05Silver Sulfadiazine50 g in 1 TUBECREAM501
87063-078-10Silver Sulfadiazine1000 g in 1 JARCREAM10001
87063-078-20Silver Sulfadiazine20 g in 1 TUBECREAM201
87063-078-25Silver Sulfadiazine25 g in 1 TUBECREAM251
87063-078-40Silver Sulfadiazine400 g in 1 JARCREAM4001
87063-078-50Silver Sulfadiazine50 g in 1 JARCREAM501
87063-078-85Silver Sulfadiazine85 g in 1 TUBECREAM851

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN4d9aa72e-b8dc-4ea3-be44-80f03ba819821
106351silver sulfadiazine 10 MG/ML Topical CreamSCD4d9aa72e-b8dc-4ea3-be44-80f03ba819821
106351silver sulfadiazine 1 % Topical CreamSY4d9aa72e-b8dc-4ea3-be44-80f03ba819821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87063-078-058706300780550 g in 1 TUBE (87063-078-05) 50 g2026-01-23NoNoHistorical
87063-078-10870630078101000 g in 1 JAR (87063-078-10) 1000 g2026-01-23NoNoHistorical
87063-078-208706300782020 g in 1 TUBE (87063-078-20) 20 g2026-01-23NoNoHistorical
87063-078-258706300782525 g in 1 TUBE (87063-078-25) 25 g2026-01-23NoNoHistorical
87063-078-4087063007840400 g in 1 JAR (87063-078-40) 400 g2026-01-23NoNoHistorical
87063-078-508706300785050 g in 1 JAR (87063-078-50) 50 g2026-01-23NoNoHistorical
87063-078-858706300788585 g in 1 TUBE (87063-078-85) 85 g2026-01-23NoNoHistorical