Trospium Chloride
These highlights do not include all the information needed to use TROSPIUM CHLORIDE TABLETS safely and effectively. See full prescribing information for TROSPIUM CHLORIDE TABLETS. TROSPIUM CHLORIDE tablets, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
a4108873-d2d2-4667-b049-02b89b8f2494
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 22, 2020
Manufacturers
FDA
Exelan Pharmaceuticals Inc.
DUNS: 967795266
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trospium Chloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76282-336
Application NumberANDA091688
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trospium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2018
FDA Product Classification
INGREDIENTS (14)
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TROSPIUM CHLORIDEActive
Quantity: 20 mg in 1 1
Code: 1E6682427E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
XYLITOLInactive
Code: VCQ006KQ1E
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT