TROSPIUM CHLORIDE
TROSPIUM CHLORIDE EXTENDED-RELEASE CAPSULES 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
ed27c30d-c83a-45af-9c47-807da858d696
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 8, 2020
Manufacturers
FDA
Bluepoint Laboratories
DUNS: 985523874
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
NDC Product Code68001-427
Application NumberANDA213185
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 8, 2020
Generic NameTROSPIUM CHLORIDE
INGREDIENTS (21)
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TROSPIUM CHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1E6682427E
Classification: ACTIB
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT