Trimethobenzamide Hydrochloride

Product NDC: 62135-773
11-digit product format: 621350773
Labeler code: 62135
Product ID: 62135-773_45ae3fa0-7a27-4f11-e063-6294a90a0f67
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimethobenzamide Hydrochloride
Dosage form: CAPSULE
Route: ORAL
Labeler: Chartwell RX, LLC
Application: ANDA205950
Marketing category: ANDA
Marketing start: 2023-11-21
Substance: TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength: 300 mg/1
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205950-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB		2023-11-21	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205950-001	TRIMETHOBENZAMIDE HYDROCHLORIDE	300MG	CAPSULE / ORAL	AB	RS	2023-11-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205950-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205950-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205950-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205950-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205950-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205950-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205950-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205950-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205950-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205950-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205950-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205950-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205950-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205950-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205950-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205950-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205950-001	AB	1	`ea1830bbd6c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205950-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trimethobenzamide Hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMETHOBENZAMIDE HYDROCHLORIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WDQ5P1SX7Q	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
860771	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
ee626da9-cffc-4bb9-a528-482687201b2a	Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
62135-773-30	Trimethobenzamide Hydrochloride	30 in 1 PACKAGE	CAPSULE	30		2
62135-773-90	Trimethobenzamide Hydrochloride	90 in 1 PACKAGE	CAPSULE	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
62135-773-30	EA - Each	62135-773	66c3835e-8ce5-4786-8fb4-0bb2f3819283	1	2023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
62135-773	TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [CHARTWELL RX, LLC]	1	Current NDC, 2 package rows	20231128_ee626da9-cffc-4bb9-a528-482687201b2a.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	Chartwell RX, LLC	ee626da9-cffc-4bb9-a528-482687201b2a	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205950 application number: ANDA205950 ndc (product): 62135-773
Trimethobenzamide Hydrochloride	TRIMETHOBENZAMIDE HYDROCHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f	2023-11-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205950 application number: ANDA205950

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WDQ5P1SX7Q	TRIMETHOBENZAMIDE HYDROCHLORIDE	554-92-7	TRIMETHOBENZAMIDE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
860771	trimethobenzamide HCl 300 MG Oral Capsule	PSN	ee626da9-cffc-4bb9-a528-482687201b2a	2
860771	trimethobenzamide hydrochloride 300 MG Oral Capsule	SCD	ee626da9-cffc-4bb9-a528-482687201b2a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
62135-773-30	62135077330	30 CAPSULE in 1 PACKAGE (62135-773-30)	30 capsule	2023-11-21	No	No	Current
62135-773-90	62135077390	90 CAPSULE in 1 PACKAGE (62135-773-90)	90 capsule	2023-11-21	No	No	Current