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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49999-185DDiscontinued by firm2026-08-11
excluded packagepackage49999-18549999-185-25DDiscontinued by firm2026-08-11
excluded packagepackage49999-18549999-185-50DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 20 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49999-185-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49999-185-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49999-185-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49999-185-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49999-185-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49999-185-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49999-185-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49999-185-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49999-185-250efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49999-185-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49999-185-25ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49999-185-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49999-185-25367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49999-185-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49999-185-25557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49999-185-50557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog.

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