Trimethobenzamide Hydrochloride

Product NDC
53489-376
11-digit product format
534890376
Labeler code
53489
Product ID
53489-376_90cbbf48-e36f-46f5-8b58-c61b16b0aa86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trimethobenzamide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA076570
Marketing category
ANDA
Marketing start
2003-08-28
Marketing end
0000-00-00
Substance
TRIMETHOBENZAMIDE HYDROCHLORIDE
Active strength
300 mg/1
Pharmacologic classes
Antiemetic [EPC],Emesis Suppression [PE]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-376-01EA - Each53489-376f9cf26a7-4143-4ff0-8e25-22e837a012fd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Trimethobenzamide HydrochlorideACTIVE INGREDIENTWDQ5P1SX7QTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TRIMETHOBENZAMIDE HYDROCHLORIDEACTIVE INGREDIENTWDQ5P1SX7QTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TRIMETHOBENZAMIDEACTIVE MOIETYW2X096QY97TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
TrimethobenzamideACTIVE MOIETYW2X096QY97TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
D&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C Red No. 40INACTIVE INGREDIENTWZB9127XOATRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
gelatinINACTIVE INGREDIENT2G86QN327LTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
GELATININACTIVE INGREDIENT2G86QN327LTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
ShellacINACTIVE INGREDIENT46N107B71OTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
sodium starch glycolate type A potatoINACTIVE INGREDIENT5856J3G2A2TRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTRIMETHOBENZAMIDE HYDROCHLORIDE (TRIMETHOBENZAMIDE) CAPSULE [REBEL DISTRIBUTORS CORP.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
860771trimethobenzamide HCl 300 MG Oral CapsulePSN43a47783-c605-49eb-a4fa-8524e75e69de1
860771trimethobenzamide hydrochloride 300 MG Oral CapsuleSCD43a47783-c605-49eb-a4fa-8524e75e69de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-376-0153489037601100 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-01) 100 capsule2003-08-280000-00-00NoNoCurrent
53489-376-0353489037603250 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-03) 250 capsule2003-08-280000-00-00NoNoCurrent
53489-376-0553489037605500 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-05) 500 capsule2003-08-280000-00-00NoNoCurrent
53489-376-065348903760660 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-06) 60 capsule2003-08-280000-00-00NoNoCurrent
53489-376-075348903760730 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-07) 30 capsule2003-08-280000-00-00NoNoCurrent
53489-376-10534890376101000 CAPSULE in 1 BOTTLE, PLASTIC (53489-376-10) 1000 capsule2003-08-280000-00-00NoNoCurrent