Probenecid

Product NDC
11819-282
11-digit product format
118190282
Labeler code
11819
Product ID
11819-282_4db8da08-120b-4098-b938-202075869844
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Probenecid
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HHS/Program Support Center/Supply Service Center
Application
ANDA084442
Marketing category
ANDA
Marketing start
1983-07-01
Marketing end
0000-00-00
Substance
PROBENECID
Active strength
500 mg/1
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct11819-282IInactivated by FDA2026-08-10
excluded packagepackage11819-28211819-282-08IInactivated by FDA2026-08-10

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 · 44 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 packagepackage11819-282-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11819-282-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11819-282-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11819-282-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11819-282-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11819-282-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11819-282-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11819-282-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11819-282-080efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11819-282-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11819-282-08367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11819-282-08557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage11819-282-088af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage11819-282-08834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage11819-282-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage11819-282-08fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage11819-282-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage11819-282-08bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage11819-282-088dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage11819-282-08e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage11819-282-089bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage11819-282-08110d247fa046…a55b01930146…

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
A084442-004PROBENECIDPROBENECID500MGTABLET / ORALABRS1983-03-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A084442-004AB

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 UTC2026-02A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A084442-004PROBENECID500MGTABLET / ORALRS1983-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A084442-004PROBENECID500MGTABLET / ORALRS1983-03-2987673890dc5c…
2021-03-12 10:30 UTC2021-03A084442-004PROBENECID500MGTABLET / ORALRS1983-03-295aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A084442-004PROBENECID500MGTABLET / ORALRS1983-03-298869cabd3fbd…
2020-11-12 02:37 UTC2020-11A084442-004PROBENECID500MGTABLET / ORALRS1983-03-29c0c555d07b60…
2019-12-14 00:12 UTC2019-12A084442-004PROBENECID500MGTABLET / ORALRS1983-03-293f01610625f2…
2019-09-15 20:21 UTC2019-09A084442-004PROBENECID500MGTABLET / ORALAB1983-03-29b00525d2431f…
2019-07-19 19:46 UTC2019-07A084442-004PROBENECID500MGTABLET / ORALAB1983-03-29ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-293f0d92c62455…
2023-05-13 08:27 UTC2023-05A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29053a50430f4f…
2023-01-26 05:58 UTC2023-01A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-293bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-293a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084442-004PROBENECID500MGTABLET / ORALABRS1983-03-29cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A084442-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A084442-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A084442-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A084442-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A084442-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A084442-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A084442-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A084442-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A084442-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A084442-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A084442-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A084442-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A084442-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A084442-004AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A084442-004AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A084442-004AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A084442-004AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A084442-004AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A084442-004AB1782e0a99824c…
2019-09-15 20:21 UTC2019-09A084442-004AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A084442-004AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A084442-004AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A084442-004AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A084442-004AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A084442-004AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A084442-004AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A084442-004AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A084442-004AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A084442-004AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A084442-004AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A084442-004AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A084442-004AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A084442-004AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A084442-004AB1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A084442-004AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e312405-bfef-73b2-fc56-fea2b3b68305Product name220250731
51989a2b-944a-b31f-835e-469c133570adProduct name220250716

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11819-282-082019-11-13C16284748780-197449f38-d193-f6ea-e053-dbdaa90aa703Probenecid Tablets USP Revised: June 2009 Rx only 190811

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11819-282-08Probenecid8 in 1 BOTTLE, PLASTICTABLET, FILM COATED81

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ProbenecidACTIVE INGREDIENTPO572Z7917PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
ProbenecidACTIVE MOIETYPO572Z7917PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11819-282PROBENECID TABLET, FILM COATED [HHS/PROGRAM SUPPORT CENTER/SUPPLY SERVICE CENTER]1Legacy NDC, 1 package rows20120302_5ca3dd4c-b8b4-4131-a066-214dabb2576f.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProbenecidPROBENECIDActavis Pharma, Inc.ae126418-5474-4fbe-b83c-bde8b2b4ae6e2024-04-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 084442
application number: ANDA084442

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198152probenecid 500 MG Oral TabletPSN5ca3dd4c-b8b4-4131-a066-214dabb2576f1
198152probenecid 500 MG Oral TabletSCD5ca3dd4c-b8b4-4131-a066-214dabb2576f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
11819-282-08118190282088 in 1 BOTTLE, PLASTICHistorical