Trimethoprim

Product NDC
68151-2010
11-digit product format
681512010
Labeler code
68151
Product ID
68151-2010_dbf1feea-e5cd-498d-be46-f3f5c35e9ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA070049
Marketing category
ANDA
Marketing start
2010-04-04
Marketing end
0000-00-00
Substance
TRIMETHOPRIM
Active strength
100 mg/1
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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 productproduct68151-2010IInactivated by FDA2026-08-03
excluded packagepackage68151-201068151-2010-0IInactivated by FDA2026-08-03

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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68151-2010-0IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68151-2010-0IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68151-2010-0IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68151-2010-0IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68151-2010-0IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68151-2010-0IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68151-2010-0IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68151-2010-0IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68151-2010-0IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68151-2010-0IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68151-2010-0IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68151-2010-0IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68151-2010-0IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68151-2010-0IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68151-2010-0IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage68151-2010-0IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage68151-2010-0IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage68151-2010-0IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage68151-2010-0IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage68151-2010-0IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage68151-2010-0IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage68151-2010-0EExcluded after deficient or non-compliant submission was not corrected110d247fa046…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
A070049-001TRIMETHOPRIMTRIMETHOPRIM100MGTABLET / ORALAB1985-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A070049-001AB

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 UTC2026-02A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-063f01610625f2…
2019-09-15 20:21 UTC2019-09A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-063bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-063a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070049-001TRIMETHOPRIM100MGTABLET / ORALAB1985-06-06cb3db0bc1861…

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 UTC2026-02A070049-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A070049-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A070049-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A070049-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A070049-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A070049-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A070049-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A070049-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A070049-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A070049-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A070049-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A070049-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A070049-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A070049-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A070049-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A070049-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A070049-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A070049-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A070049-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A070049-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A070049-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A070049-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A070049-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A070049-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A070049-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A070049-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A070049-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A070049-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A070049-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A070049-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A070049-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A070049-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A070049-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A070049-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A070049-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A070049-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A070049-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A070049-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A070049-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A070049-001AB1cb3db0bc1861…

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
68151-2010-02020-01-31C16284748780-19d75b9d0-b75b-f424-e053-dadaa90a57ceTRIMETHOPRIM TABLETS, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-2010-0Trimethoprim1 in 1 PACKAGETABLET14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIMETHOPRIMACTIVE INGREDIENTAN164J8Y0XTRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
TRIMETHOPRIMACTIVE MOIETYAN164J8Y0XTRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-2010TRIMETHOPRIM TABLET [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20170706_e38742cd-3411-46bf-a74b-526b16c79729.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198332trimethoprim 100 MG Oral TabletPSNe38742cd-3411-46bf-a74b-526b16c797294
198332trimethoprim 100 MG Oral TabletSCDe38742cd-3411-46bf-a74b-526b16c797294
198332TMP 100 MG Oral TabletSYe38742cd-3411-46bf-a74b-526b16c797294

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-2010-0681512010001 in 1 PACKAGEHistorical