Silver Sulfadiazine

Product NDC
45865-642
11-digit product format
458650642
Labeler code
45865
Product ID
45865-642_7205c0e2-d7be-3451-e053-2a95a90a69b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Medsource Pharmaceuticals
Application
NDA018810
Marketing category
NDA
Marketing start
1985-12-23
Marketing end
0000-00-00
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
45865-642-012025-01-30C16284748780-12cef2736-b50c-d83d-e063-dadaa90ab31f7205c0e2-d7bd-3451-e053-2a95a90a69b0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-642-01Silver Sulfadiazine25 g in 1 TUBECREAM251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-642SILVER SULFADIAZINE CREAM [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20180728_7205c0e2-d7bd-3451-e053-2a95a90a69b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN7205c0e2-d7bd-3451-e053-2a95a90a69b01
106351silver sulfadiazine 10 MG/ML Topical CreamSCD7205c0e2-d7bd-3451-e053-2a95a90a69b01
106351silver sulfadiazine 1 % Topical CreamSY7205c0e2-d7bd-3451-e053-2a95a90a69b01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-642-014586506420125 g in 1 TUBE (45865-642-01) 25 g2018-01-010000-00-00NoNoCurrent