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 use Initial U.S. Approval: December 2000
Approved
Approval ID
fcaca033-cd08-4b8c-9bad-7b6751faf2c9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 24, 2021
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-192
Application NumberANDA213397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (11)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 4 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
Tolterodine tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code27241-191
Application NumberANDA213397
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tolterodine tartrate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 24, 2021
FDA Product Classification
INGREDIENTS (12)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
TOLTERODINE TARTRATEActive
Quantity: 2 mg in 1 1
Code: 5T619TQR3R
Classification: ACTIB
ETHYLCELLULOSE, UNSPECIFIEDInactive
Code: 7Z8S9VYZ4B
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
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
OLEIC ACIDInactive
Code: 2UMI9U37CP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT