Trospium Chloride
These highlights do not include all the information needed to use Trospium Chloride Extended-Release Capsules safely and effectively. See full prescribing information for Trospium Chloride Extended-Release Capsules. Trospium Chloride Extended-Release Capsules For oral use. Initial U.S. Approval: 2004
Approved
Approval ID
dfc1af0b-b0e7-43fd-8da0-65281963bc3e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 13, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-1106
Application NumberANDA201291
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trospium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 13, 2023
FDA Product Classification
INGREDIENTS (18)
TROSPIUM CHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1E6682427E
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8J
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT