Home NDC 43386-660 Trimethobenzamide Hydrochloride
Product NDC 43386-660
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A076546-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076546-001 TRIMETHOBENZAMIDE HYDROCHLORIDE 300MG CAPSULE / ORAL AB 2003-08-20 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Trimethobenzamide Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIMETHOBENZAMIDE HYDROCHLORIDE 300 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WDQ5P1SX7Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 860771 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43386-660-03 Trimethobenzamide Hydrochloride 30 in 1 BOTTLE CAPSULE 30 5 43386-660-24 Trimethobenzamide Hydrochloride 100 in 1 BOTTLE CAPSULE 100 5 43386-660-26 Trimethobenzamide Hydrochloride 500 in 1 BOTTLE CAPSULE 500 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRIMETHOBENZAMIDE HYDROCHLORIDE ACTIVE INGREDIENT WDQ5P1SX7Q TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 TRIMETHOBENZAMIDE ACTIVE MOIETY W2X096QY97 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 D&C RED NO. 28 INACTIVE INGREDIENT 767IP0Y5NH TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 ETHYLENE GLYCOL MONOETHYL ETHER INACTIVE INGREDIENT IDK7C2HS09 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 GELATIN INACTIVE INGREDIENT 2G86QN327L TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 LECITHIN, SOYBEAN INACTIVE INGREDIENT 1DI56QDM62 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 SHELLAC INACTIVE INGREDIENT 46N107B71O TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2 WATER INACTIVE INGREDIENT 059QF0KO0R TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [GAVIS PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-660 TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [LUPIN PHARMACEUTICALS,INC.] 5 Current NDC, Legacy NDC, 3 package rows 20240131_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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 43386-660-03 43386066003 30 CAPSULE in 1 BOTTLE (43386-660-03) 30 capsule 2011-01-17 0000-00-00 No No Current 43386-660-24 43386066024 100 CAPSULE in 1 BOTTLE (43386-660-24) 100 capsule 2011-01-17 0000-00-00 No No Current 43386-660-26 43386066026 500 CAPSULE in 1 BOTTLE (43386-660-26) 500 capsule 2011-01-17 0000-00-00 No No Current