Trimethoprim

Product NDC
63629-7731
11-digit product format
636297731
Labeler code
63629
Product ID
63629-7731_dca1ec08-6fa9-4d66-81fe-b3f7d4afb1c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091437
Marketing category
ANDA
Marketing start
2011-06-24
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
No
Listing certified through
2021-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-7731DDiscontinued by firm2026-08-03
excluded packagepackage63629-773163629-7731-1DDiscontinued by firm2026-08-03
excluded packagepackage63629-773163629-7731-2DDiscontinued by firm2026-08-03
excluded packagepackage63629-773163629-7731-3DDiscontinued by firm2026-08-03

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 · 52 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 productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7731-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7731-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-7731-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7731-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7731-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-7731-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7731-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7731-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-7731-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7731-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7731-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-7731-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7731-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7731-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-7731-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7731-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7731-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-7731-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7731-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7731-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-7731-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7731-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7731-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-7731-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7731-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7731-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-7731-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7731-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7731-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-7731-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7731-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7731-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-7731-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7731-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7731-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-7731-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7731-2IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7731-3IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage63629-7731-1IInactivated by FDA9bebd1f3094a…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
A091437-001TRIMETHOPRIMTRIMETHOPRIM100MGTABLET / ORALAB2011-06-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091437-001AB

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 UTC2026-02A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-153f01610625f2…
2019-09-15 20:21 UTC2019-09A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091437-001TRIMETHOPRIM100MGTABLET / ORALAB2011-06-15cb3db0bc1861…

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 UTC2026-02A091437-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091437-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091437-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091437-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091437-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091437-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091437-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091437-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091437-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091437-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091437-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091437-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091437-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091437-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091437-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091437-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091437-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091437-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091437-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091437-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091437-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091437-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091437-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091437-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091437-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091437-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091437-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091437-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091437-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091437-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091437-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091437-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091437-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091437-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A091437-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A091437-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A091437-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A091437-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091437-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091437-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrimethoprimTRIMETHOPRIMLupin Pharmaceuticals,Inc.249e938d-f181-47c4-a082-372d65462f332024-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091437
application number: ANDA091437
TrimethoprimTRIMETHOPRIMNovel Laboratories, Inc.b27e43b5-670b-43f6-b28b-413e54f914da2017-06-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091437
application number: ANDA091437

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7731-16362977310130 TABLET in 1 BOTTLE (63629-7731-1) 30 tablet2018-07-060000-00-00NoNoCurrent
63629-7731-26362977310210 TABLET in 1 BOTTLE (63629-7731-2) 10 tablet2018-07-060000-00-00NoNoCurrent
63629-7731-36362977310345 TABLET in 1 BOTTLE (63629-7731-3) 45 tablet2018-07-060000-00-00NoNoCurrent