FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
0093-2050
11-digit product format
000932050
Labeler code
0093
Product ID
0093-2050_95042583-c90a-40a9-98e1-bdd849df6e8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA Inc
Application
NDA021228
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-02
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
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-2050DDiscontinued by firm2026-07-31
excluded packagepackage0093-20500093-2050-05DDiscontinued by firm2026-07-31
excluded packagepackage0093-20500093-2050-56DDiscontinued by firm2026-07-31
excluded packagepackage0093-20500093-2050-98DDiscontinued 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2050-05EA - Each0093-20500ece7fcb-9ac1-4ed4-98ad-f77f067362ce12014-02-04
0093-2050-56EA - Each0093-2050cb1e0eda-db61-4d78-9d35-fbf7f3a8f79b12014-02-04
0093-2050-98EA - Each0093-2050cc01e59d-b9bd-4c3d-89cf-c67959a6d84812014-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY09b4ec42-9b47-4a6c-b219-7c5dcda35ac54