FDA.reportPublic FDA data

Tolterodine Tartrate Extended Release

Product NDC
59762-0048
11-digit product format
597620048
Labeler code
59762
Product ID
59762-0048_41ea8bd1-9374-41a1-8a14-f77ec72f0273
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021228
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-12-30
Marketing end
2026-07-31
Substance
TOLTERODINE TARTRATE
Active strength
4 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 Extended Release

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855182, 855189

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
59762-0048-1Tolterodine Tartrate Extended Release30 in 1 BOTTLECAPSULE, EXTENDED RELEASE309
59762-0048-2Tolterodine Tartrate Extended Release90 in 1 BOTTLECAPSULE, EXTENDED RELEASE909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0048-1EA - Each59762-00485bea4a41-87af-4136-88f0-3f26ac98a80312016-02-04
59762-0048-2EA - Each59762-00486b67334f-ebe8-43b1-9962-86adcc086ba012016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPTOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1
SUCROSEINACTIVE INGREDIENTC151H8M554TOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [GREENSTONE LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0048TOLTERODINE TARTRATE EXTENDED RELEASE (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20250504_0565f75a-3f4f-436e-930e-c31c6fa2b1e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN0565f75a-3f4f-436e-930e-c31c6fa2b1e79
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN0565f75a-3f4f-436e-930e-c31c6fa2b1e79
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD0565f75a-3f4f-436e-930e-c31c6fa2b1e79
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD0565f75a-3f4f-436e-930e-c31c6fa2b1e79
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY0565f75a-3f4f-436e-930e-c31c6fa2b1e79
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY0565f75a-3f4f-436e-930e-c31c6fa2b1e79

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0048-15976200480130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-1) 2014-12-302026-05-31NoNoCurrent
59762-0048-25976200480290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-2) 2014-12-302026-07-31NoNoCurrent
59762-0048-359762004803500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59762-0048-3) 2014-12-300000-00-00NoNoCurrent