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 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
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
2026-02-19 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
2026-02-19 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…

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 · 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

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

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