Trimethobenzamide Hydrochloride
Approved
Approval ID
1e2348ed-b72b-4779-9207-faa3ce303487
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 24, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5741
Application NumberANDA076570
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethobenzamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2010
FDA Product Classification
INGREDIENTS (13)
TRIMETHOBENZAMIDE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: WDQ5P1SX7Q
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT