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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51407-739

Application NumberANDA204562

Product Classification

Marketing Category

C73584

Generic Name

Tolterodine Tartrate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

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

FDA regulatory identification and product classification information

FDA Identifiers

NDC Product Code51407-740

Application NumberANDA204562

Product Classification

Marketing Category

C73584

Generic Name

Tolterodine Tartrate

Product Specifications

Route of AdministrationORAL

Effective DateDecember 28, 2023

FDA Product Classification

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

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Tolterodine Tartrate

Products 2

Tolterodine Tartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (16)

Tolterodine Tartrate

Product Details

FDA Identifiers

Product Classification

Product Specifications

INGREDIENTS (15)

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