Silver Sulfadiazine

Product NDC
63629-8768
11-digit product format
636298768
Labeler code
63629
Product ID
63629-8768_e5731b14-359d-4f54-8882-6242d42b7f78
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
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
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
63629-8768-1Silver Sulfadiazine20 g in 1 TUBECREAM20103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8768-1GM - Gram63629-876821ad8212-ac01-43ff-a3b0-0379ad703a8112021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8768SILVER SULFADIAZINE CREAM [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20241024_d02fe8b9-2a20-40e7-8674-19768ff4d42d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNd02fe8b9-2a20-40e7-8674-19768ff4d42d103
106351silver sulfadiazine 10 MG/ML Topical CreamSCDd02fe8b9-2a20-40e7-8674-19768ff4d42d103
106351silver sulfadiazine 1 % Topical CreamSYd02fe8b9-2a20-40e7-8674-19768ff4d42d103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8768-16362987680120 g in 1 TUBE (63629-8768-1) 20 g1985-12-230000-00-00NoNoCurrent