Trimethobenzamide Hydrochloride

Product NDC
23155-180
11-digit product format
231550180
Labeler code
23155
Product ID
23155-180_0b8a6f4d-f844-41f5-9659-ec3989cfc390
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethobenzamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205950
Marketing category
ANDA
Marketing start
2023-11-21
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
A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDETRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205950-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALAB2023-11-21ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205950-001TRIMETHOBENZAMIDE HYDROCHLORIDE300MGCAPSULE / ORALABRS2023-11-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A205950-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A205950-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205950-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205950-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205950-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205950-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205950-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205950-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A205950-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A205950-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A205950-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A205950-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A205950-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A205950-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A205950-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A205950-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A205950-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A205950-001AB1ea1830bbd6c7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A205950-001AB1a50c72e98297…

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
b0aa9b7e-bbe7-482e-81d3-d9658d5ac21fAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-180-01Trimethobenzamide Hydrochloride100 in 1 BOTTLECAPSULE1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-180TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]6Current NDC, 1 package rows20231122_b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f.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 HYDROCHLORIDEChartwell RX, LLCee626da9-cffc-4bb9-a528-482687201b2a2025-12-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205950
application number: ANDA205950
Trimethobenzamide HydrochlorideTRIMETHOBENZAMIDE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.b0aa9b7e-bbe7-482e-81d3-d9658d5ac21f2023-11-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205950
application number: ANDA205950
ndc (product): 23155-180

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860771trimethobenzamide HCl 300 MG Oral CapsulePSNb0aa9b7e-bbe7-482e-81d3-d9658d5ac21f6
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCDb0aa9b7e-bbe7-482e-81d3-d9658d5ac21f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
23155-180-0123155018001100 CAPSULE in 1 BOTTLE (23155-180-01) 100 capsule2023-11-21NoNoCurrent