TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)

Product NDC: 51662-1430
11-digit product format: 516621430
Labeler code: 51662
Product ID: 51662-1430_0ffba8c5-bf5e-a665-e063-6294a90a64f6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: HF Acquisition Co LLC, DBA HealthFirst
Application: NDA017530
Marketing category: NDA
Marketing start: 2020-01-10
Substance: TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength: 100 mg/mL
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
N017530-001	TIGAN	TRIMETHOBENZAMIDE HYDROCHLORIDE	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N017530-001	AP

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	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION	AP	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N017530-001	TIGAN	100MG/ML	INJECTABLE / INJECTION		RLD, RS, Approved before 1982	`cb3db0bc1861…`

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	N017530-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N017530-001	AP	1	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N017530-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TRIMETHOBENZAMIDE HYDROCHLORIDE	100 mg/mL

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
1726680	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
9bd0bfa0-c189-751c-e053-2a95a90a5f5a	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
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
51662-1430-1	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2	4
51662-1430-2	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2	4
51662-1430-2	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	1 in 1 POUCH	INJECTION	1	4
51662-1430-3	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	25 in 1 CASE	INJECTION	25	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51662-1430	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]	4	Current NDC, Legacy NDC, 4 package rows	20240129_9bd0bfa0-c189-751c-e053-2a95a90a5f5a.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tigan	TRIMETHOBENZAMIDE HYDROCHLORIDE	Par Health USA, LLC	7da90678-b229-4ad6-9193-2b8a3e9ba695	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017530 application number: NDA017530
Tigan	TRIMETHOBENZAMIDE HYDROCHLORIDE	Henry Schein, Inc	147def93-cd3d-4e42-89ad-6a6b413bf362	2025-10-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017530 application number: NDA017530
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)	HF Acquisition Co LLC, DBA HealthFirst	9bd0bfa0-c189-751c-e053-2a95a90a5f5a	2024-01-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 017530 application number: NDA017530 ndc (product): 51662-1430

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
1726680	trimethobenzamide HCl 200 MG in 2 ML Injection	PSN	9bd0bfa0-c189-751c-e053-2a95a90a5f5a	4
1726680	2 ML trimethobenzamide hydrochloride 100 MG/ML Injection	SCD	9bd0bfa0-c189-751c-e053-2a95a90a5f5a	4
1726680	trimethobenzamide hydrochloride 200 MG per 2 ML Injection	SY	9bd0bfa0-c189-751c-e053-2a95a90a5f5a	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51662-1430-1	51662143001	2 mL in 1 VIAL, SINGLE-DOSE (51662-1430-1)	2 ml	2020-01-10	0000-00-00	No	No	Current
51662-1430-2	51662143002	2 mL in 1 VIAL, SINGLE-DOSE	2 ml					Historical
51662-1430-3	51662143003	25 POUCH in 1 CASE (51662-1430-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1430-2) / 2 mL in 1 VIAL, SINGLE-DOSE	25 pouch	2022-12-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION 200mg/2mL (100mg/mL) 2mL VIAL	HF Acquisition Co LLC, DBA HealthFirst	2024-01-28	HUMAN PRESCRIPTION DRUG LABEL	4