Trimethobenzamide Hydrochloride
These highlights do not include all the information needed to use TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for TRIMETHOBENZAMIDE HYDROCHLORIDE CAPSULES.TRIMETHOBENZAMIDE HYDROCHLORIDE capsules, for oral useInitial U.S. Approval: 1974
Approved
Approval ID
588e2253-cef6-4a97-b5a0-01eb11ab44d6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2017
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trimethobenzamide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53489-376
Application NumberANDA076570
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethobenzamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 17, 2017
FDA Product Classification
INGREDIENTS (15)
Trimethobenzamide HydrochlorideActive
Quantity: 300 mg in 1 1
Code: WDQ5P1SX7Q
Classification: ACTIB
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ferric oxide redInactive
Code: 1K09F3G675
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Aluminum oxideInactive
Code: LMI26O6933
Classification: IACT
D&C yellow no. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C blue no. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C blue no. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
Sodium Starch Glycolate Type A PotatoInactive
Code: 5856J3G2A2
Classification: IACT