FDA.reportPublic FDA data

SILVADENE

Product NDC
61570-131
11-digit product format
615700131
Labeler code
61570
Product ID
61570-131_2d9a5dc8-0dfd-42b8-a641-b4b82a113fab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
silver sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA017381
Marketing category
NDA
Marketing start
1973-11-26
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
Pharmacologic classes
Sulfonamide Antibacterial [EPC], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SILVADENE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILVER SULFADIAZINE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW46JY43EJR
Rxcui106351, 208186

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
61570-131-20SILVADENE20 g in 1 TUBECREAM2019
61570-131-20SILVADENE1 in 1 CARTONCREAM119
61570-131-25SILVADENE25 g in 1 TUBECREAM2519
61570-131-25SILVADENE1 in 1 CARTONCREAM119
61570-131-40SILVADENE400 g in 1 JARCREAM40019
61570-131-50SILVADENE50 g in 1 JARCREAM5019
61570-131-55SILVADENE50 g in 1 TUBECREAM5019
61570-131-55SILVADENE1 in 1 CARTONCREAM119
61570-131-85SILVADENE85 g in 1 TUBECREAM8519
61570-131-85SILVADENE1 in 1 CARTONCREAM119
61570-131-98SILVADENE1000 g in 1 JARCREAM100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61570-131-20GM - Gram61570-131576c1b70-a780-45cd-a7ef-0840e969f9b112012-07-24
61570-131-25GM - Gram61570-131b8b498b2-3a5b-4b40-a462-f1e324c618b912015-06-09
61570-131-40GM - Gram61570-131fd1ebb66-40d9-4c78-b50b-5e3ca7eb5bbc12012-07-24
61570-131-50GM - Gram61570-131c8c5af05-c4c6-452e-bd7c-d58876746ca012012-07-24
61570-131-55GM - Gram61570-131b0eff2f2-0a48-4c26-a939-903c46efa89912015-06-09
61570-131-85GM - Gram61570-131d62270e4-6159-4aaf-807a-ade34036b0da12012-07-24
61570-131-98GM - Gram61570-1310bc2a501-ea49-4b58-8a45-3d093c8c89c712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILVER SULFADIAZINEACTIVE INGREDIENTW46JY43EJRSILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]9
SULFADIAZINEACTIVE MOIETY0N7609K889SILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61570-131SILVADENE (SILVER SULFADIAZINE) CREAM [PFIZER LABORATORIES DIV PFIZER INC]17Current NDC, Legacy NDC, 11 package rows20210717_c437213a-1cd4-445e-a39f-bbcacb9f746f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
208186Silvadene 1 % Topical CreamPSNc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfADIAZINE 1 % Topical CreamPSNc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBDc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfadiazine 10 MG/ML Topical CreamSCDc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 1 % Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 10 MG/ML Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
106351silver sulfadiazine 1 % Topical CreamSYc437213a-1cd4-445e-a39f-bbcacb9f746f19
208186Silvadene 1 % Topical CreamPSN54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfADIAZINE 1 % Topical CreamPSN54b77a36-205b-4044-9ecb-c5130f0934b518
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBD54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfadiazine 10 MG/ML Topical CreamSCD54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 1 % Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 10 MG/ML Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
106351silver sulfadiazine 1 % Topical CreamSY54b77a36-205b-4044-9ecb-c5130f0934b518
208186Silvadene 1 % Topical CreamPSN9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfADIAZINE 1 % Topical CreamPSN9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186silver sulfadiazine 10 MG/ML Topical Cream [Silvadene]SBD9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfadiazine 10 MG/ML Topical CreamSCD9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186Silvadene 1 % Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
208186Silvadene 10 MG/ML Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71
106351silver sulfadiazine 1 % Topical CreamSY9b6715e6-4117-4a22-b219-ce0ba5bb2fa71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61570-131-20615700131201 TUBE in 1 CARTON (61570-131-20) / 20 g in 1 TUBE1 tube1973-11-260000-00-00NoNoCurrent
61570-131-25615700131251 TUBE in 1 CARTON (61570-131-25) / 25 g in 1 TUBE1 tube2015-05-260000-00-00NoNoCurrent
61570-131-4061570013140400 g in 1 JAR (61570-131-40) 400 g1973-11-260000-00-00NoNoCurrent
61570-131-506157001315050 g in 1 JAR (61570-131-50) 50 g1973-11-260000-00-00NoNoCurrent
61570-131-55615700131551 TUBE in 1 CARTON (61570-131-55) / 50 g in 1 TUBE1 tube2015-05-260000-00-00NoNoCurrent
61570-131-85615700131851 TUBE in 1 CARTON (61570-131-85) / 85 g in 1 TUBE1 tube1973-11-260000-00-00NoNoCurrent
61570-131-98615700131981000 g in 1 JAR (61570-131-98) 1000 g1973-11-260000-00-00NoNoCurrent