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
4574f905-a8c5-4732-b934-d1c7f9e708c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 22, 2021
Manufacturers
FDA
Padagis US LLC
DUNS: 967694121
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 Code0574-0118
Application NumberANDA201291
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 22, 2021
Generic NameTrospium Chloride
INGREDIENTS (18)
Trospium ChlorideActive
Quantity: 60 mg in 1 1
Code: 1E6682427E
Classification: ACTIB
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
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
FD&C yellow no. 6Inactive
Code: H77VEI93A8
Classification: IACT
shellacInactive
Code: 46N107B71O
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
potassium hydroxideInactive
Code: WZH3C48M4T
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
ferrosoferric oxideInactive
Code: XM0M87F357
Classification: IACT
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT