Trimethobenzamide Hydrochloride

Product NDC
43386-660
Requested package NDC
43386-660-24
11-digit product format
433860660
Labeler code
43386
Product ID
43386-660_49c03212-c2eb-49b8-bc11-bbfd75122965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethobenzamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA076546
Marketing category
ANDA
Marketing start
2011-01-17
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 42.

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
A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076546-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-208072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-204b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-2087673890dc5c…
2021-03-12 10:30 UTC2021-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-205aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-208869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203f01610625f2…
2019-09-15 20:21 UTC2019-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20b00525d2431f…
2019-07-19 19:46 UTC2019-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-206a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-201c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-209b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203f0d92c62455…
2023-05-13 08:27 UTC2023-05A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20053a50430f4f…
2023-01-26 05:58 UTC2023-01A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-203a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076546-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2003-08-20e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076546-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076546-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076546-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076546-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076546-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076546-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076546-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076546-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A076546-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A076546-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A076546-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A076546-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A076546-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A076546-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A076546-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A076546-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A076546-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A076546-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A076546-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A076546-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A076546-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A076546-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A076546-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A076546-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A076546-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A076546-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A076546-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A076546-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A076546-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A076546-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A076546-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A076546-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A076546-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A076546-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A076546-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A076546-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A076546-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A076546-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A076546-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076546-001AB1e64feba35796…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIMETHOBENZAMIDE HYDROCHLORIDE300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WDQ5P1SX7QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c18073be-d52a-4347-a8d1-6be11bcb7824Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5cb11add-3f77-4e14-9823-b8ca5e31d965Product name120250804
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43386-660-03Trimethobenzamide Hydrochloride30 in 1 BOTTLECAPSULE305
43386-660-24Trimethobenzamide Hydrochloride100 in 1 BOTTLECAPSULE1005
43386-660-26Trimethobenzamide Hydrochloride500 in 1 BOTTLECAPSULE5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43386-660-03EA - Each43386-660fcd94491-2d24-4e71-8054-eb0d63070fdf12013-11-04
43386-660-24EA - Each43386-6605291c777-d626-47c5-a28d-92430cdd939012012-07-24
43386-660-26EA - Each43386-6602c850f56-e251-45e7-bde8-870c8e24edbd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRIMETHOBENZAMIDE HYDROCHLORIDEACTIVE INGREDIENTWDQ5P1SX7QTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
TRIMETHOBENZAMIDEACTIVE MOIETYW2X096QY97TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
SHELLACINACTIVE INGREDIENT46N107B71OTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-660TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 3 package rows20240131_c18073be-d52a-4347-a8d1-6be11bcb7824.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEBryant Ranch Prepack00ba5395-1455-4ea9-9278-e3749979526c2024-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076546
application number: ANDA076546
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDELupin Pharmaceuticals,Inc.c18073be-d52a-4347-a8d1-6be11bcb78242024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076546
application number: ANDA076546
ndc (package): 43386-660-24
ndc (product): 43386-660
ndc11 (package): 43386066024

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860771trimethobenzamide HCl 300 MG Oral CapsulePSNc18073be-d52a-4347-a8d1-6be11bcb78245
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCDc18073be-d52a-4347-a8d1-6be11bcb78245
860771trimethobenzamide HCl 300 MG Oral CapsulePSN00ba5395-1455-4ea9-9278-e3749979526c4
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCD00ba5395-1455-4ea9-9278-e3749979526c4
860771trimethobenzamide HCl 300 MG Oral CapsulePSN8ccb7a57-a1e4-55f7-e053-2a95a90a792b2
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCD8ccb7a57-a1e4-55f7-e053-2a95a90a792b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43386-660-2443386066024100 CAPSULE in 1 BOTTLE (43386-660-24) 100 capsule2011-01-170000-00-00NoNoCurrent