FDA.reportPublic FDA data

Detrol LA

Product NDC
69189-5190
11-digit product format
691895190
Labeler code
69189
Product ID
69189-5190_7a741f41-ad7c-425b-b0a7-af78e490b4d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Avera McKennan Hospital
Application
NDA021228
Marketing category
NDA
Marketing start
2016-03-16
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
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69189-5190IInactivated by FDA2026-07-31
excluded packagepackage69189-519069189-5190-1IInactivated by FDA2026-07-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69189-5190-12020-01-31C16284748780-19d75b9d0-56a4-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use Detrol ® LA safely and effectively. See full prescribing information for Detrol LA. Detrol ® LA (tolterodine tartrate extended release capsules) For oral administration Initial U.S. Approval: December 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69189-5190-1Detrol LA1 in 1 DOSE PACKCAPSULE, EXTENDED RELEASE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69189-5190DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [AVERA MCKENNAN HOSPITAL]1Legacy NDC, 1 package rows20170411_88df13b1-090d-4894-a60a-878b370409c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855184Detrol LA 2 MG 24HR Extended Release Oral CapsulePSN88df13b1-090d-4894-a60a-878b370409c01
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN88df13b1-090d-4894-a60a-878b370409c01
85518424 HR tolterodine tartrate 2 MG Extended Release Oral Capsule [Detrol]SBD88df13b1-090d-4894-a60a-878b370409c01
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD88df13b1-090d-4894-a60a-878b370409c01
85518424 HR Detrol 2 MG Extended Release Oral CapsuleSY88df13b1-090d-4894-a60a-878b370409c01
855184Detrol LA 2 MG 24 HR Extended Release Oral CapsuleSY88df13b1-090d-4894-a60a-878b370409c01
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY88df13b1-090d-4894-a60a-878b370409c01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
69189-5190-1691895190011 in 1 DOSE PACKHistorical