FDA.reportPublic FDA data

Silver Sulfadiazine

Product NDC
61919-237
11-digit product format
619190237
Labeler code
61919
Product ID
61919-237_4d3a460b-1b9a-2906-e063-6294a90a3669
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
DIRECT RX
Application
NDA018578
Marketing category
NDA
Marketing start
2014-01-01
Marketing end
2027-09-30
Substance
SILVER SULFADIAZINE
Active strength
10 g/1000g
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Silver Sulfadiazine

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 g/1000g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW46JY43EJR
Rxcui106351

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
61919-237-252025-01-30C16284748780-12cef2736-b3aa-d83d-e063-dadaa90ab31fSilver Sulfadiazine

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-237-25Silver Sulfadiazine25 g in 1 TUBECREAM255

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-237-25GM - Gram61919-237741ced7f-9ecb-4f71-adf2-a50fcf2fff0612024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Silver SulfadiazineACTIVE INGREDIENTW46JY43EJRSILVER SULFADIAZINE CREAM [DIRECT RX]1
SILVER CATIONACTIVE MOIETY57N7B0K90ASILVER SULFADIAZINE CREAM [DIRECT RX]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSILVER SULFADIAZINE CREAM [DIRECT RX]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSILVER SULFADIAZINE CREAM [DIRECT RX]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSILVER SULFADIAZINE CREAM [DIRECT RX]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USILVER SULFADIAZINE CREAM [DIRECT RX]1
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISILVER SULFADIAZINE CREAM [DIRECT RX]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SILVER SULFADIAZINE CREAM [DIRECT RX]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56SILVER SULFADIAZINE CREAM [DIRECT RX]1
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSILVER SULFADIAZINE CREAM [DIRECT RX]1
WATERINACTIVE INGREDIENT059QF0KO0RSILVER SULFADIAZINE CREAM [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-237SILVER SULFADIAZINE CREAM [DIRECT RX]4Current NDC, Legacy NDC, 1 package rows20230112_7ef0cf79-e960-44a6-acac-797913b71c97.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106351silver sulfADIAZINE 1 % Topical CreamPSN7ef0cf79-e960-44a6-acac-797913b71c975
106351silver sulfadiazine 10 MG/ML Topical CreamSCD7ef0cf79-e960-44a6-acac-797913b71c975
106351silver sulfadiazine 1 % Topical CreamSY7ef0cf79-e960-44a6-acac-797913b71c975

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-237-256191902372525 g in 1 TUBE (61919-237-25) 25 g2015-01-012027-09-30NoNoCurrent