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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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6593
Application NumberANDA203016
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOLTERODINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2019
FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0904-6592
Application NumberANDA203016
Product Classification
M
Marketing Category
C73584
G
Generic Name
TOLTERODINE
Product Specifications
Route of AdministrationORAL
Effective DateNovember 13, 2019
FDA Product Classification

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

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