FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
59762-0800
Requested package NDC
59762-0800-6
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

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 packagepackage59762-080059762-0800-6DDiscontinued 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
N020771-001DETROLTOLTERODINE TARTRATE1MGTABLET / ORALABRLD1998-03-25
N020771-002DETROLTOLTERODINE TARTRATE2MGTABLET / ORALABRLD, RS1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020771-001AB
N020771-002AB

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 22:54:322026-06N020771-001DETROL1MGTABLET / ORALABRLD1998-03-25a50c72e98297…
2026-08-01 22:54:322026-06N020771-002DETROL2MGTABLET / ORALABRLD, RS1998-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020771-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020771-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEMylan Pharmaceuticals Inc.9e432622-2e6f-4cf8-892f-510288dd50f22024-09-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771
ndc (package): 59762-0800-6
ndc (product): 59762-0800
ndc11 (package): 59762080006
DetrolTOLTERODINE TARTRATEViatris Specialty LLC41eb00d2-64e3-4ec9-8732-4bfc81b041802023-02-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771

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
59762-0800-659762080006500 TABLET, FILM COATED in 1 BOTTLE (59762-0800-6) 2014-01-212026-07-31NoNoCurrent