FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
59762-0800
11-digit product format
597620800
Labeler code
59762
Product ID
59762-0800_fdede630-529a-48fe-b796-59c3504c8d32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020771
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-21
Marketing end
2026-07-31
Substance
TOLTERODINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine Tartrate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855178, 855194

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-0800-2Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED6012
59762-0800-6Tolterodine Tartrate500 in 1 BOTTLETABLET, FILM COATED50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0800-2EA - Each59762-0800065565e9-6ed0-41cf-b902-8ab03fa6d50612014-02-04
59762-0800-6EA - Each59762-08005e5c556b-e179-451f-b122-af24272f8cc412014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0800TOLTERODINE TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 2 package rows20250504_9e432622-2e6f-4cf8-892f-510288dd50f2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSN9e432622-2e6f-4cf8-892f-510288dd50f212
855194tolterodine tartrate 2 MG Oral TabletPSN9e432622-2e6f-4cf8-892f-510288dd50f212
855178tolterodine tartrate 1 MG Oral TabletSCD9e432622-2e6f-4cf8-892f-510288dd50f212
855194tolterodine tartrate 2 MG Oral TabletSCD9e432622-2e6f-4cf8-892f-510288dd50f212

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0800-25976208000260 TABLET, FILM COATED in 1 BOTTLE (59762-0800-2) 2014-01-212026-06-30NoNoCurrent
59762-0800-659762080006500 TABLET, FILM COATED in 1 BOTTLE (59762-0800-6) 2014-01-212026-07-31NoNoCurrent