Tigan

Product NDC: 0404-9964
11-digit product format: 004049964
Labeler code: 0404
Product ID: 0404-9964_8b0d1e9b-0b2a-42c4-b51e-ef42340482f5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimethobenzamide Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: Henry Schein, Inc
Application: NDA017530
Marketing category: NDA
Marketing start: 2022-01-11
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (product): 0404-9964
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

Additional Listing Data#

Finished product: Yes
Brand name base: Tigan
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1726680	Internal RxNorm lookup
1726682	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
147def93-cd3d-4e42-89ad-6a6b413bf362	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	Strength	SPL version
0404-9964-02	Tigan	2 mL in 1 VIAL, SINGLE-DOSE	INJECTION	2		7
0404-9964-02	Tigan	1 in 1 BAG	INJECTION	1		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0404-9964	TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [HENRY SCHEIN, INC]	4	Current NDC, Legacy NDC, 2 package rows	20241018_147def93-cd3d-4e42-89ad-6a6b413bf362.zip

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
1726682	Tigan 200 MG in 2 ML Injection	PSN	147def93-cd3d-4e42-89ad-6a6b413bf362	7
1726680	trimethobenzamide HCl 200 MG in 2 ML Injection	PSN	147def93-cd3d-4e42-89ad-6a6b413bf362	7
1726682	2 ML trimethobenzamide hydrochloride 100 MG/ML Injection [Tigan]	SBD	147def93-cd3d-4e42-89ad-6a6b413bf362	7
1726680	2 ML trimethobenzamide hydrochloride 100 MG/ML Injection	SCD	147def93-cd3d-4e42-89ad-6a6b413bf362	7
1726682	Tigan 200 MG per 2 ML Injection	SY	147def93-cd3d-4e42-89ad-6a6b413bf362	7
1726680	trimethobenzamide hydrochloride 200 MG per 2 ML Injection	SY	147def93-cd3d-4e42-89ad-6a6b413bf362	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0404-9964-02	00404996402	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9964-02) / 2 mL in 1 VIAL, SINGLE-DOSE	2022-01-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tigan (trimethobenzamide hydrochloride) Injectable	Henry Schein, Inc	2025-10-14	HUMAN PRESCRIPTION DRUG LABEL	7