Silver Sulfadiazine

Product NDC
68387-450
11-digit product format
683870450
Labeler code
68387
Product ID
68387-450_36c67b60-9529-4f19-a4b8-b68788f836c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Keltman Pharmaceuticals Inc.
Application
ANDA018578
Marketing category
ANDA
Marketing start
2007-03-10
Marketing end
0000-00-00
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68387-450-012019-10-29C16284748780-1960f7f55-cfaa-8e05-e053-dbdaa90a074asilver sulfadiazine 1% cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68387-450-01Silver Sulfadiazine50 g in 1 JARCREAM502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68387-450-01GM - Gram68387-4505541c74f-07ab-447c-82c9-ecb7794564ee12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68387-450SILVER SULFADIAZINE CREAM [KELTMAN PHARMACEUTICALS INC.]2Legacy NDC, 1 package rows20101013_27c5999a-0bbe-4d20-9a9e-3546c8189ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN27c5999a-0bbe-4d20-9a9e-3546c8189ae32
106351silver sulfadiazine 10 MG/ML Topical CreamSCD27c5999a-0bbe-4d20-9a9e-3546c8189ae32
106351silver sulfadiazine 1 % Topical CreamSY27c5999a-0bbe-4d20-9a9e-3546c8189ae32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68387-450-016838704500150 g in 1 JAR50 gHistorical