Trimethobenzamide
Trimethobenzamide
Approved
Approval ID
8ccb7a57-a1e4-55f7-e053-2a95a90a792b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2023
Manufacturers
FDA
Direct_Rx
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trimethobenzamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-884
Application NumberANDA076546
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethobenzamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2023
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
TRIMETHOBENZAMIDE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: WDQ5P1SX7Q
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT