SILVADENE

Product NDC
76413-124
11-digit product format
764130124
Labeler code
76413
Product ID
76413-124_ca111e2f-b81d-4518-9178-8d01ec50ac19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
silver sulfadiazine
Dosage form
CREAM
Route
TOPICAL
Labeler
Central Texas Community Health Centers
Application
NDA017381
Marketing category
NDA
Marketing start
1973-11-26
Marketing end
0000-00-00
Substance
SILVER SULFADIAZINE
Active strength
10 mg/g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct76413-124IInactivated by FDA2026-08-11
excluded packagepackage76413-12476413-124-20IInactivated by FDA2026-08-11

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 · 42 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage76413-124-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage76413-124-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage76413-124-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage76413-124-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage76413-124-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage76413-124-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage76413-124-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage76413-124-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage76413-124-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage76413-124-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage76413-124-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage76413-124-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage76413-124-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage76413-124-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage76413-124-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage76413-124-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage76413-124-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage76413-124-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage76413-124-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage76413-124-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage76413-124-209bebd1f3094a…5416666fcb17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017381-001SILVADENESILVER SULFADIAZINE1%CREAM / TOPICALABRLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N017381-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017381-001SILVADENE1%CREAM / TOPICALABRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017381-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017381-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N017381-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017381-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017381-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017381-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017381-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017381-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017381-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017381-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017381-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017381-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017381-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017381-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017381-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017381-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017381-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017381-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017381-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017381-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017381-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N017381-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017381-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017381-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017381-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N017381-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N017381-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017381-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017381-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017381-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017381-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017381-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017381-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017381-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N017381-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N017381-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017381-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017381-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017381-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017381-001AB1cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76413-124-202020-01-31C16284748780-19d75b9d0-80e9-f424-e053-dadaa90a57ceSILVADENE ® CREAM 1% (silver sulfadiazine)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76413-124-20SILVADENE1 in 1 CARTONCREAM11
76413-124-20SILVADENE20 g in 1 TUBECREAM201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-124SILVADENE (SILVER SULFADIAZINE) CREAM [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]1Legacy NDC, 2 package rows20160126_9b6715e6-4117-4a22-b219-ce0ba5bb2fa7.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SILVADENESILVER SULFADIAZINEPfizer Laboratories Div Pfizer Incc437213a-1cd4-445e-a39f-bbcacb9f746f2026-01-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381
SILVER SULFADIAZINESILVER SULFADIAZINEMylan Pharmaceuticals Inc.7a6a9590-9983-46ff-ae5c-fe95f4e16cb82025-12-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381
SILVADENESILVER SULFADIAZINEA-S Medication Solutions54b77a36-205b-4044-9ecb-c5130f0934b52023-12-09Warnings, Adverse reactionsExact identifier
application applno (NDA): 017381
application number: NDA017381

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionStatus
76413-124-20764130124201 in 1 CARTONHistorical