Tigan

Product NDC
21695-853
11-digit product format
216950853
Labeler code
21695
Product ID
21695-853_97191d37-7c2e-48c6-91bf-0631fd7b1dd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trimethobenzamide hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Rebel Distributors Corp
Application
NDA017530
Marketing category
NDA
Marketing start
2007-11-01
Marketing end
0000-00-00
Substance
TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength
100 mg/mL
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct21695-853IInactivated by FDA2026-08-03
excluded packagepackage21695-85321695-853-20IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

Observed captured status history: Rows come only from successfully parsed FDA auxiliary ZIP captures. They show the state present in that artifact, not a continuous regulatory timeline. Absence before, after, or between captures is not proof of status, and a known non-data HTTP 403 capture is preserved in backfill provenance but cannot produce a status row.

Historic NDC status page 1 of 1 · 44 matching rows.

Browse every current auxiliary row. · Browse the complete NDC auxiliary source catalog.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct21695-853IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-85321695-853-20IInactivated by FDAexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017530-001TIGANTRIMETHOBENZAMIDE HYDROCHLORIDE100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

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

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONAPRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N017530-001TIGAN100MG/MLINJECTABLE / INJECTIONRLD, RS, Approved before 1982cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N017530-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017530-001AP131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N017530-001AP1a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEPar Health USA, LLC7da90678-b229-4ad6-9193-2b8a3e9ba6952026-03-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530
TiganTRIMETHOBENZAMIDE HYDROCHLORIDEHenry Schein, Inc147def93-cd3d-4e42-89ad-6a6b413bf3622025-10-14Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530
TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)TIGAN(R) (TRIMETHOBENZAMIDE HYDROCHLORIDE)HF Acquisition Co LLC, DBA HealthFirst9bd0bfa0-c189-751c-e053-2a95a90a5f5a2024-01-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 017530
application number: NDA017530

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5cb11add-3f77-4e14-9823-b8ca5e31d965Product name120250804

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-853-202019-09-24C16284748780-1934fe258-4ad0-48b1-e053-8cdaa90a720aTigan® (trimethobenzamide hydrochloride)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-853-20Tigan1 in 1 CARTONINJECTION11
21695-853-20Tigan20 mL in 1 VIAL, MULTI-DOSEINJECTION201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-853-20ML - Milliliter21695-853c53ae7b7-3b76-4de6-a350-543db644e81212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
trimethobenzamide hydrochlorideACTIVE INGREDIENTWDQ5P1SX7QTIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1
trimethobenzamideACTIVE MOIETYW2X096QY97TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-853TIGAN (TRIMETHOBENZAMIDE HYDROCHLORIDE) INJECTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20110104_97191d37-7c2e-48c6-91bf-0631fd7b1dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860751Tigan 100 MG/ML Injectable SolutionPSN97191d37-7c2e-48c6-91bf-0631fd7b1dd81
860749trimethobenzamide HCl 100 MG/ML Injectable SolutionPSN97191d37-7c2e-48c6-91bf-0631fd7b1dd81
860751trimethobenzamide hydrochloride 100 MG/ML Injectable Solution [Tigan]SBD97191d37-7c2e-48c6-91bf-0631fd7b1dd81
860749trimethobenzamide hydrochloride 100 MG/ML Injectable SolutionSCD97191d37-7c2e-48c6-91bf-0631fd7b1dd81
860751Tigan 100 MG/ML Injectable SolutionSY97191d37-7c2e-48c6-91bf-0631fd7b1dd81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-853-20216950853201 in 1 CARTONHistorical