Trimethobenzamide

Product NDC: 61919-884
11-digit product format: 619190884
Labeler code: 61919
Product ID: 61919-884_f216106d-2256-fc25-e053-2a95a90aeff8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimethobenzamide
Dosage form: CAPSULE
Route: ORAL
Labeler: Direct_Rx
Application: ANDA076546
Marketing category: ANDA
Marketing start: 2019-07-03
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: 2024-12-31
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-884		I	Inactivated by FDA		2026-08-03
excluded package	package	61919-884	61919-884-30	I	Inactivated by FDA		2026-08-03

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-884-30	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-884-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-884-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-884-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-884-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-884-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-884-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-884-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-884-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5cb11add-3f77-4e14-9823-b8ca5e31d965	Product name	1	20250804

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
61919-884-30	2025-01-30	C162847	48780-1	2cef2736-5a4e-d83d-e063-dadaa90ab31f	Trimethobenzamide

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
61919-884-30	Trimethobenzamide	30 in 1 BOTTLE	CAPSULE	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-884-30	EA - Each	61919-884	58053987-aaff-4492-bf7b-960c4a25e42e	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-884	TRIMETHOBENZAMIDE CAPSULE [DIRECT_RX]	2	Legacy NDC, 1 package rows	20230113_8ccb7a57-a1e4-55f7-e053-2a95a90a792b.zip

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
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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WDQ5P1SX7Q	TRIMETHOBENZAMIDE HYDROCHLORIDE	554-92-7	TRIMETHOBENZAMIDE HYDROCHLORIDE
W2X096QY97	TRIMETHOBENZAMIDE	138-56-7	Trimethobenzamide

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860771	trimethobenzamide HCl 300 MG Oral Capsule	PSN	8ccb7a57-a1e4-55f7-e053-2a95a90a792b	2
860771	trimethobenzamide hydrochloride 300 MG Oral Capsule	SCD	8ccb7a57-a1e4-55f7-e053-2a95a90a792b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61919-884-30	61919088430	30 CAPSULE in 1 BOTTLE (61919-884-30)	30 capsule	2019-07-03	0000-00-00	No	No	Current