Sulfamethoxazole and Trimethoprim

Product NDC
53808-0981
11-digit product format
538080981
Labeler code
53808
Product ID
53808-0981_e3305dd9-e369-4db8-9274-f94fca384ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
State of Florida DOH Central Pharmacy
Application
ANDA090828
Marketing category
ANDA
Marketing start
2013-01-01
Marketing end
0000-00-00
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
Pharmacologic classes
Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53808-0981IInactivated by FDA2026-08-03
excluded packagepackage53808-098153808-0981-1IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 6 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct53808-0981IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53808-098153808-0981-1IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct53808-0981IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53808-098153808-0981-1IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct53808-0981IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53808-098153808-0981-1IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22
A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIMSULFAMETHOXAZOLE; TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A090828-001AB
A090828-002AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-2274a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-2274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090828-001SULFAMETHOXAZOLE AND TRIMETHOPRIM800MG;160MGTABLET / ORALAB2010-12-22782e0a99824c…
2021-12-28 21:50 UTC2021-12A090828-002SULFAMETHOXAZOLE AND TRIMETHOPRIM400MG;80MGTABLET / ORALAB2010-12-22782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A090828-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090828-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090828-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090828-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090828-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090828-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090828-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090828-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090828-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090828-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090828-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090828-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090828-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090828-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090828-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090828-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090828-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090828-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090828-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090828-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090828-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090828-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090828-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090828-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090828-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090828-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090828-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090828-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090828-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ce811b5-329e-27f8-b5ff-66d52b435c00Product name320240108
8d30c4f0-0228-cea4-e3aa-f19064c47f27Product name320221128
6e20c430-5e8f-85da-1b03-f7dbc0c51fadProduct name320190926
c1381fd7-868a-f499-ef90-8f6d3e3ee6b3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53808-0981-12020-01-31C16284748780-19d75b9d0-7b79-f424-e053-dadaa90a57ceSulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (Double Strength) and 400 mg/80 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53808-0981-1Sulfamethoxazole and Trimethoprim30 in 1 BLISTER PACKTABLET302

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53808-0981SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]2Legacy NDC, 1 package rows20140428_3add3659-fd33-4e5d-ad9b-8486aa10220d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletPSN3add3659-fd33-4e5d-ad9b-8486aa10220d2
198335sulfamethoxazole 800 MG / trimethoprim 160 MG Oral TabletSCD3add3659-fd33-4e5d-ad9b-8486aa10220d2
198335SMX 800 MG / TMP 160 MG Oral TabletSY3add3659-fd33-4e5d-ad9b-8486aa10220d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53808-0981-15380809810130 in 1 BLISTER PACKHistorical