Trimethobenzamide Hydrochloride
Trimethobenzamide Hydrochloride Capsules, USP 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 capsule, for oral use Initial U.S. Approval: 1974
Approved
Approval ID
ee626da9-cffc-4bb9-a528-482687201b2a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 27, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-773
Application NumberANDA205950
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethobenzamide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateNovember 27, 2023
FDA Product Classification
INGREDIENTS (16)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
DEHYDRATED ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TRIMETHOBENZAMIDE HYDROCHLORIDEActive
Quantity: 300 mg in 1 1
Code: WDQ5P1SX7Q
Classification: ACTIB
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT