FDA.reportPublic FDA data

SSD Cream

Product NDC
43598-210
11-digit product format
435980210
Labeler code
43598
Product ID
43598-210_4a712d7e-58d2-91eb-bf5f-6cdedfb33097
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Silver Sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Dr Reddys Laboratories Inc
Application
NDA018578
Marketing category
NDA
Marketing start
2011-05-04
Marketing end
2028-01-31
Substance
SILVER SULFADIAZINE
Active strength
10 g/1000g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SSD Cream

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 g/1000g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW46JY43EJR
Rxcui106351, 208185

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
43598-210-25SSD Cream25 g in 1 TUBECREAM254
43598-210-40SSD Cream400 g in 1 JARCREAM4004
43598-210-50SSD Cream50 g in 1 TUBECREAM504
43598-210-55SSD Cream50 g in 1 JARCREAM504
43598-210-85SSD Cream85 g in 1 TUBECREAM854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-210-25GM - Gram43598-2107da17afb-e530-4b31-8bdc-c7d1f8f2e89a12012-07-24
43598-210-40GM - Gram43598-210b21b5933-2a85-4160-a954-659bfec70b9212012-07-24
43598-210-50GM - Gram43598-2104cf02737-abfb-4352-ab26-e0a5d996eb4d12012-07-24
43598-210-55GM - Gram43598-210b870e324-b7e5-4230-9808-7e5b27022ffc12012-07-24
43598-210-85GM - Gram43598-2107f4d7c02-29b8-416a-ab14-89836a83a28d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Silver SulfadiazineACTIVE INGREDIENTW46JY43EJRSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
SulfadiazineACTIVE MOIETY0N7609K889SSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9USSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
POLYOXYL 40 STEARATEINACTIVE INGREDIENT13A4J4NH9ISSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56SSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
WATERINACTIVE INGREDIENT059QF0KO0RSSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]2
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
43598-210SSD CREAM (SILVER SULFADIAZINE) CREAM [DR REDDYS LABORATORIES INC]3Current NDC, Legacy NDC, 5 package rows20190426_30d6dc33-e457-466b-9159-d8e7cd791820.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
106351silver sulfADIAZINE 1 % Topical CreamPSN30d6dc33-e457-466b-9159-d8e7cd7918204
208185SSD 1 % Topical CreamPSN30d6dc33-e457-466b-9159-d8e7cd7918204
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBD30d6dc33-e457-466b-9159-d8e7cd7918204
106351silver sulfadiazine 10 MG/ML Topical CreamSCD30d6dc33-e457-466b-9159-d8e7cd7918204
106351silver sulfadiazine 1 % Topical CreamSY30d6dc33-e457-466b-9159-d8e7cd7918204
208185SSD 1 % Topical CreamSY30d6dc33-e457-466b-9159-d8e7cd7918204
208185SSD 10 MG/ML Topical CreamSY30d6dc33-e457-466b-9159-d8e7cd7918204
106351silver sulfADIAZINE 1 % Topical CreamPSNc6a40aee-ef43-e40b-e053-2995a90ae0482
106351silver sulfADIAZINE 1 % Topical CreamPSN2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
208185SSD 1 % Topical CreamPSN2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBD2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
106351silver sulfadiazine 10 MG/ML Topical CreamSCDc6a40aee-ef43-e40b-e053-2995a90ae0482
106351silver sulfadiazine 10 MG/ML Topical CreamSCD2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
106351silver sulfadiazine 1 % Topical CreamSYc6a40aee-ef43-e40b-e053-2995a90ae0482
106351silver sulfadiazine 1 % Topical CreamSY2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
208185SSD 1 % Topical CreamSY2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
208185SSD 10 MG/ML Topical CreamSY2a3f8ce0-6e6d-43c9-9564-a5ec2626b7972
106351silver sulfADIAZINE 1 % Topical CreamPSN37670ded-5d4a-4e98-e063-6394a90a15711
106351silver sulfADIAZINE 1 % Topical CreamPSNbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfADIAZINE 1 % Topical CreamPSNbee162c3-2627-4f28-9715-11a351d497eb1
106351silver sulfADIAZINE 1 % Topical CreamPSN24b01ac4-3ed5-db3d-e063-6394a90a06291
106351silver sulfADIAZINE 1 % Topical CreamPSN1cfe8e5a-8951-acea-e063-6394a90a18111
106351silver sulfADIAZINE 1 % Topical CreamPSNe5d40c82-99a7-a0a4-e053-2995a90a76081
208185SSD 1 % Topical CreamPSN37670ded-5d4a-4e98-e063-6394a90a15711
208185SSD 1 % Topical CreamPSNbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 1 % Topical CreamPSNe5d40c82-99a7-a0a4-e053-2995a90a76081
208185SSD 1 % Topical CreamPSN1cfe8e5a-8951-acea-e063-6394a90a18111
208185SSD 1 % Topical CreamPSN24b01ac4-3ed5-db3d-e063-6394a90a06291
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBD37670ded-5d4a-4e98-e063-6394a90a15711
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBD24b01ac4-3ed5-db3d-e063-6394a90a06291
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBD1cfe8e5a-8951-acea-e063-6394a90a18111
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBDe5d40c82-99a7-a0a4-e053-2995a90a76081
208185silver sulfadiazine 10 MG/ML Topical Cream [SSD]SBDbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfadiazine 10 MG/ML Topical CreamSCD24b01ac4-3ed5-db3d-e063-6394a90a06291
106351silver sulfadiazine 10 MG/ML Topical CreamSCD37670ded-5d4a-4e98-e063-6394a90a15711
106351silver sulfadiazine 10 MG/ML Topical CreamSCD1cfe8e5a-8951-acea-e063-6394a90a18111
106351silver sulfadiazine 10 MG/ML Topical CreamSCDe5d40c82-99a7-a0a4-e053-2995a90a76081
106351silver sulfadiazine 10 MG/ML Topical CreamSCDbee162c3-2627-4f28-9715-11a351d497eb1
106351silver sulfadiazine 10 MG/ML Topical CreamSCDbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfadiazine 1 % Topical CreamSYe5d40c82-99a7-a0a4-e053-2995a90a76081
106351silver sulfadiazine 1 % Topical CreamSY37670ded-5d4a-4e98-e063-6394a90a15711
106351silver sulfadiazine 1 % Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31
106351silver sulfadiazine 1 % Topical CreamSYbee162c3-2627-4f28-9715-11a351d497eb1
106351silver sulfadiazine 1 % Topical CreamSY24b01ac4-3ed5-db3d-e063-6394a90a06291
106351silver sulfadiazine 1 % Topical CreamSY1cfe8e5a-8951-acea-e063-6394a90a18111
208185SSD 1 % Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 1 % Topical CreamSY37670ded-5d4a-4e98-e063-6394a90a15711
208185SSD 1 % Topical CreamSY24b01ac4-3ed5-db3d-e063-6394a90a06291
208185SSD 1 % Topical CreamSYe5d40c82-99a7-a0a4-e053-2995a90a76081
208185SSD 1 % Topical CreamSY1cfe8e5a-8951-acea-e063-6394a90a18111
208185SSD 10 MG/ML Topical CreamSYbf1367b4-3075-4373-8998-d9006f680df31
208185SSD 10 MG/ML Topical CreamSY37670ded-5d4a-4e98-e063-6394a90a15711
208185SSD 10 MG/ML Topical CreamSY24b01ac4-3ed5-db3d-e063-6394a90a06291
208185SSD 10 MG/ML Topical CreamSY1cfe8e5a-8951-acea-e063-6394a90a18111
208185SSD 10 MG/ML Topical CreamSYe5d40c82-99a7-a0a4-e053-2995a90a76081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-210-254359802102525 g in 1 TUBE (43598-210-25) 25 g2011-05-042027-09-30NoNoCurrent
43598-210-4043598021040400 g in 1 JAR (43598-210-40) 400 g2011-05-042028-01-31NoNoCurrent
43598-210-504359802105050 g in 1 TUBE (43598-210-50) 50 g2011-05-042027-12-31NoNoCurrent
43598-210-554359802105550 g in 1 JAR (43598-210-55) 50 g2011-05-042027-11-30NoNoCurrent
43598-210-854359802108585 g in 1 TUBE (43598-210-85) 85 g2011-05-042027-12-31NoNoCurrent