FDA.reportPublic FDA data

Tolterodine Tartrate Extended Release

Product NDC
59762-0048
Requested package NDC
59762-0048-1
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59762-004859762-0048-1DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021228-001DETROL LATOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22
N021228-002DETROL LATOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N021228-001AB
N021228-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021228-001DETROL LA2MGCAPSULE, EXTENDED RELEASE / ORALABRLD2000-12-22a50c72e98297…
2026-08-01 22:54:322026-06N021228-002DETROL LA4MGCAPSULE, EXTENDED RELEASE / ORALABRLD, RS2000-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N021228-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N021228-002AB1a50c72e98297…

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