Tigan

Product NDC: 52584-119
Requested package NDC: 52584-119-25
11-digit product format: 525840119
Labeler code: 52584
Product ID: 52584-119_ebeddafa-8f42-4323-8e0e-3b55a1fb7d68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trimethobenzamide Hydrochloride
Dosage form: INJECTION
Route: INTRAMUSCULAR
Labeler: General Injectables & Vaccines, Inc
Application: NDA017530
Marketing category: NDA
Marketing start: 2010-08-01
Marketing end: 2024-09-30
Substance: TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength: 100 mg/mL
Pharmacologic classes: Antiemetic [EPC], Emesis Suppression [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52584-119	52584-119-25	D	Discontinued by firm		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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
Trimethobenzamide Hydrochloride	ACTIVE INGREDIENT	WDQ5P1SX7Q	TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1
Trimethobenzamide	ACTIVE MOIETY	W2X096QY97	TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION, SOLUTION [GENERAL INJECTABLES & VACCINES, INC]	1

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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52584-119-25	52584011925	1 VIAL, SINGLE-DOSE in 1 BAG (52584-119-25) > 2 mL in 1 VIAL, SINGLE-DOSE	2010-08-01	2024-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Tigan 100 mg/mL Injection 2 mL Single Dose Vial	General Injectables & Vaccines, Inc	2022-12-27	HUMAN PRESCRIPTION DRUG LABEL	10