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 administration Initial U.S. Approval: December 2000
Approved
Approval ID
da9423b5-00ab-46fc-8959-3db3c0a0bc6d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 11, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
TOLTERODINE
PRODUCT DETAILS
NDC Product Code0904-6593
Application NumberANDA203016
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 13, 2019
Generic NameTOLTERODINE
INGREDIENTS (9)
TOLTERODINE TARTRATEActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TOLTERODINE
PRODUCT DETAILS
NDC Product Code0904-6592
Application NumberANDA203016
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 13, 2019
Generic NameTOLTERODINE
INGREDIENTS (9)
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT