FDA.reportPublic FDA data

NDC 80425-0221-01 - Silver Sulfadiazine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0221
Requested NDC
80425-0221-01
Package NDCs from labels
80425-0221-1, 80425-0221-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Silver Sulfadiazine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0221-1Silver Sulfadiazine50 g in 1 TUBECREAM503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0221SILVER SULFADIAZINE CREAM [ADVANCED RX PHARMACY OF TENNESSEE, LLC]3Current NDC, 1 package rows20250102_f1a0f489-0d9e-66c4-e053-2a95a90a063d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0221-1GM - Gram80425-0221831fc269-75e7-4c90-bfe2-1445074e785712023-06-06

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 20 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SSD CreamSILVER SULFADIAZINEPreferred Pharmaceuticals Inc.cb7d2adf-d69d-4686-b9cf-c83d73acc4412026-08-31Warnings, Adverse reactionsExact identifier
unii: W46JY43EJR
Silver sulfadiazineSILVER SULFADIAZINEAscend Laboratories, LLCb4d6694f-2b0a-4d64-9e05-2fef6d8e60d92026-07-13Warnings, Adverse reactionsExact identifier
application number: NDA018810
ndc (product): 67877-124
rxcui: 106351
spl id: 696a2756-1fed-4550-8245-70a045866293
spl set id: b4d6694f-2b0a-4d64-9e05-2fef6d8e60d9
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINESt. Mary's Medical Park Pharmacy24b01ac4-3ed5-db3d-e063-6394a90a06292026-06-10Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINENuCare Pharmaceuticals,Inc.c6a40aee-ef43-e40b-e053-2995a90ae0482026-05-12Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEDIRECT RX7ef0cf79-e960-44a6-acac-797913b71c972026-03-17Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Thermazene Silver SulfadiazineSILVER SULFADIAZINEPreferred Pharmaceuticals, Inc.42c3ece4-0df0-4ed8-ac0f-a65fad19eed72026-02-16Warnings, Adverse reactionsExact identifier
application number: NDA018810
unii: W46JY43EJR
SILVADENESILVER SULFADIAZINEPfizer Laboratories Div Pfizer Incc437213a-1cd4-445e-a39f-bbcacb9f746f2026-01-26Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.4d9aa72e-b8dc-4ea3-be44-80f03ba819822026-01-23Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
SILVER SULFADIAZINESILVER SULFADIAZINEMylan Pharmaceuticals Inc.7a6a9590-9983-46ff-ae5c-fe95f4e16cb82025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions72ca5cb5-14d2-45e4-8b53-ed5809b0aeca2025-12-05Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions067895f9-a797-4cbd-a3d2-d611d512fe5b2025-06-17Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINENuCare Pharmaceuticals, Inc.37670ded-5d4a-4e98-e063-6394a90a15712025-06-12Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAdvanced Rx Pharmacy of Tennessee, LLCf1a0f489-0d9e-66c4-e053-2a95a90a063d2024-12-31Warnings, Adverse reactionsExact identifier
application number: NDA018810
ndc (package): 80425-0221-1
ndc (product): 80425-0221
ndc11 (package): 80425022101
rxcui: 106351
spl id: 2a9b1617-60ce-f8ce-e063-6294a90ab02c
spl set id: f1a0f489-0d9e-66c4-e053-2a95a90a063d
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutionsa4051ae4-f1ef-4082-920f-97d176b4cef22024-11-11Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
SSDSILVER SULFADIAZINEA-S Medication Solutionsbf1367b4-3075-4373-8998-d9006f680df32024-11-08Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEProficient Rx LP532d776e-54b3-4d4f-bb7a-94927bfba4d22024-03-01Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEA-S Medication Solutions475953ba-b555-474c-9bcd-8cd314cc0d1f2024-01-31Warnings, Adverse reactionsExact identifier
application number: NDA018810
rxcui: 106351
unii: W46JY43EJR
SILVADENESILVER SULFADIAZINEA-S Medication Solutions54b77a36-205b-4044-9ecb-c5130f0934b52023-12-09Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
Silver SulfadiazineSILVER SULFADIAZINEAsclemed USA, Inc.bee162c3-2627-4f28-9715-11a351d497eb2022-03-08Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR
SSD CreamSILVER SULFADIAZINEDr Reddys Laboratories Inc30d6dc33-e457-466b-9159-d8e7cd7918202019-04-24Warnings, Adverse reactionsExact identifier
rxcui: 106351
unii: W46JY43EJR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.