Application 076546

Type: ANDA
Sponsor: LUPIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	CAPSULE;ORAL	300MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2003-08-20

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076546-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	2003-08-20	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076546-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076546-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076546-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076546-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076546-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076546-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076546-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076546-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076546-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076546-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076546-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076546-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076546-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076546-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076546-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076546-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076546-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076546-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076546-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076546-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076546-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076546-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076546-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076546-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076546-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076546-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076546-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076546-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076546-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076546-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076546-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076546-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076546-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076546-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076546-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076546-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076546-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076546-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076546-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076546-001	AB	1	`cb3db0bc1861…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Bryant Ranch Prepack	00ba5395-1455-4ea9-9278-e3749979526c	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076546 application number: ANDA076546 ndc (product): 71335-0800
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Lupin Pharmaceuticals,Inc.	c18073be-d52a-4347-a8d1-6be11bcb7824	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076546 application number: ANDA076546 ndc (product): 43386-660

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43386-660	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Lupin Pharmaceuticals,Inc.	ANDA	Current
43386-660	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Lupin Pharmaceuticals,Inc.	ANDA	Current
50090-2122	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	A-S Medication Solutions	ANDA	Current
61919-884	Trimethobenzamide	Trimethobenzamide	Direct_Rx	ANDA	Current
61919-884	Trimethobenzamide	Trimethobenzamide	Direct_Rx	ANDA	Current
70518-0510	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
70518-0510	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	REMEDYREPACK INC.	ANDA	Current
71335-0800	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-0800	Trimethobenzamide Hydrochloride	Trimethobenzamide Hydrochloride	Bryant Ranch Prepack	ANDA	Current