FDA.reportPublic FDA data

TOLTERODINE TARTRATE

Product NDC
0904-6592
Requested package NDC
0904-6592-04
11-digit product format
009046592
Labeler code
0904
Product ID
0904-6592_51952461-8eb1-453b-b923-4fcaf6b78b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLTERODINE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203016
Marketing category
ANDA
Marketing start
2015-08-11
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage0904-65920904-6592-04DDiscontinued 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
A203016-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11
A203016-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203016-001AB
A203016-002AB

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 22:54:322026-06A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203016-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203016-002AB1a50c72e98297…

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 TARTRATETOLTERODINETorrent Pharmaceuticals Limiteddb6e0b6d-0ce5-41d7-881f-881c11f530a42026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203016
application number: ANDA203016
Tolterodine TartrateTOLTERODINEAmerican Health Packaging8cd23ff7-71ba-4391-95bd-a3a7f347713d2025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203016
application number: ANDA203016

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
0904-6592-04TOLTERODINE TARTRATE1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE19
0904-6592-04TOLTERODINE TARTRATE30 in 1 CARTONCAPSULE, EXTENDED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6592-04EA - Each0904-659298186b68-020e-445a-9016-20dedbab486b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6592TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Legacy NDC, 2 package rows20250515_da9423b5-00ab-46fc-8959-3db3c0a0bc6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6592-040090465920430 BLISTER PACK in 1 CARTON (0904-6592-04) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2015-08-110000-00-00NoNoCurrent