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 Initial U.S. Approval: 2004
Approved
Approval ID
8e5e2b3a-467b-4312-9778-8ff2ce938838
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2018
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
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 Code60429-098
Application NumberANDA091289
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trospium Chloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2018
FDA Product Classification
INGREDIENTS (25)
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)Inactive
Code: 99Q3C7L77T
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TROSPIUM CHLORIDEActive
Quantity: 60 mg in 1 1
Code: 1E6682427E
Classification: ACTIB