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 USP, for oral useInitial U.S. Approval: 2004
Approved
Approval ID
11367381-62c6-4a8c-84c7-031dd75372e2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 23, 2017
Manufacturers
FDA
BIOMES PHARMACEUTICALS LLC
DUNS: 078644310
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 Code69150-258
Application NumberANDA091575
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trospium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 25, 2017
FDA Product Classification
INGREDIENTS (17)
TROSPIUM CHLORIDEActive
Quantity: 20 mg in 1 1
Code: 1E6682427E
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
CROSCARMELLOSEInactive
Code: 029TFK992N
Classification: IACT