FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
UniiWDQ5P1SX7Q
Rxcui860771

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

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
43386-660-034338606600330 CAPSULE in 1 BOTTLE (43386-660-03) 30 capsule2011-01-170000-00-00NoNoCurrent
43386-660-2443386066024100 CAPSULE in 1 BOTTLE (43386-660-24) 100 capsule2011-01-170000-00-00NoNoCurrent
43386-660-2643386066026500 CAPSULE in 1 BOTTLE (43386-660-26) 500 capsule2011-01-170000-00-00NoNoCurrent