Trimethobenzamide Hydrochloride

Product NDC
70518-0510
11-digit product format
705180510
Labeler code
70518
Product ID
70518-0510_85926e83-f487-4783-e053-2991aa0af18e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethobenzamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA076546
Marketing category
ANDA
Marketing start
2017-05-09
Marketing end
0000-00-00
Substance
TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct70518-0510DDiscontinued by firm2026-08-03
excluded packagepackage70518-051070518-0510-0DDiscontinued 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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct70518-0510DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-051070518-0510-0DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…

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
A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076546-001AB

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 UTC2026-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20cb3db0bc1861…

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 UTC2026-02A076546-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076546-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076546-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076546-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076546-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076546-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076546-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076546-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076546-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076546-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076546-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076546-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076546-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076546-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076546-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076546-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076546-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076546-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076546-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076546-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076546-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076546-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076546-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076546-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076546-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076546-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076546-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076546-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076546-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076546-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076546-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076546-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076546-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076546-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076546-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076546-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076546-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076546-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076546-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076546-001AB1cb3db0bc1861…

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
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEBryant Ranch Prepack00ba5395-1455-4ea9-9278-e3749979526c2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076546
application number: ANDA076546
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.c18073be-d52a-4347-a8d1-6be11bcb78242024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076546
application number: ANDA076546