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
bbbee85a-e5e2-24ec-e053-2995a90acfd8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2023
Manufacturers
FDA
Slate Run Pharmaceuticals, LLC
DUNS: 039452765
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-160
Application NumberANDA213858
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (15)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Tolterodine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70436-161
Application NumberANDA213858
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine Tartrate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 13, 2023
FDA Product Classification
INGREDIENTS (15)
TOLTERODINE TARTRATEActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT