Tolterodine Tartrate
Tolterodine tartrate extended-release capsules. 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
05b92da2-923b-3c04-e063-6394a90a69a1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2023
Manufacturers
FDA
Golden State Medical Supply, Inc.
DUNS: 603184490
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tolterodine Tartrate
PRODUCT DETAILS
NDC Product Code51407-739
Application NumberANDA204562
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameTolterodine Tartrate
INGREDIENTS (16)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
Tolterodine Tartrate
PRODUCT DETAILS
NDC Product Code51407-740
Application NumberANDA204562
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 28, 2023
Generic NameTolterodine Tartrate
INGREDIENTS (15)
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ETHYLCELLULOSE (10 MPA.S)Inactive
Code: 3DYK7UYZ62
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIBUTYL SEBACATEInactive
Code: 4W5IH7FLNY
Classification: IACT
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)Inactive
Code: 87Y6436BKR
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB