Tolterodine Tartrate
These highlights do not include all the information needed to use TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for TOLTERODINE TARTRATE EXTENDED-RELEASE CAPSULES. TOLTERODINE TARTRATE extended-release capsules, for oral administrationInitial U.S. Approval: December 2000
Approved
Approval ID
fd6c8b3d-a52a-4418-aa9c-0297db6c0807
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 5, 2023
Manufacturers
FDA
A-S Medication Solutions
DUNS: 830016429
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolterodine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50090-3475
Application NumberANDA079141
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 20, 2023
FDA Product Classification
INGREDIENTS (13)
TOLTERODINE TARTRATEActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ETHYLCELLULOSE (7 MPA.S)Inactive
Code: H3UP11403C
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYDROXYPROPYL CELLULOSE (110000 WAMW)Inactive
Code: 5Y0974F5PW
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT