Silver Sulfadiazine

Product NDC
49999-185
11-digit product format
499990185
Labeler code
49999
Product ID
49999-185_db7d1140-e012-4f5b-8bf4-144366965c28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application
ANDA018578
Marketing category
ANDA
Marketing start
2012-03-22
Marketing end
0000-00-00
Substance
SILVER SULFADIAZINE
Active strength
10 g/1000g
Pharmacologic classes
Sulfonamide Antibacterial [EPC],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2019-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49999-185-25Silver Sulfadiazine25 g in 1 TUBECREAM253792
49999-185-50Silver Sulfadiazine50 g in 1 JARCREAM503792

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-185-25GM - Gram49999-1852f7d17c9-282f-4779-90ea-ca64912c439912013-02-13
49999-185-50GM - Gram49999-18549777b8b-d1ac-4385-bd6c-cc3c75deb54c12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
SILVER SULFADIAZINEACTIVE MOIETYW46JY43EJRSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56SILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792
WATERINACTIVE INGREDIENT059QF0KO0RSILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49999-185SILVER SULFADIAZINE CREAM [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3792Legacy NDC, 2 package rows20120502_f81457dc-2671-458f-8ed5-b45528e6aa17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSNf81457dc-2671-458f-8ed5-b45528e6aa173792
106351silver sulfadiazine 10 MG/ML Topical CreamSCDf81457dc-2671-458f-8ed5-b45528e6aa173792
106351silver sulfadiazine 1 % Topical CreamSYf81457dc-2671-458f-8ed5-b45528e6aa173792

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
49999-185-254999901852525 g in 1 TUBE25 gHistorical
49999-185-504999901855050 g in 1 JAR50 gHistorical