FDA.reportPublic FDA data

Detrol LA

Product NDC
58151-103
11-digit product format
581510103
Labeler code
58151
Product ID
58151-103_0ca22b08-46d1-4b6f-b9e7-d6a5dd534a1c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA021228
Marketing category
NDA
Marketing start
2024-01-10
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct58151-103DDiscontinued by firm2026-07-31
excluded packagepackage58151-10358151-103-05DDiscontinued by firm2026-07-31
excluded packagepackage58151-10358151-103-77DDiscontinued by firm2026-07-31
excluded packagepackage58151-10358151-103-93DDiscontinued 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
58151-103-05Detrol LA500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
58151-103-77Detrol LA90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905
58151-103-93Detrol LA30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-103-77EA - Each58151-1031e4a52b2-4d7d-4ac0-8f19-001b37b2d1e812024-02-14
58151-103-93EA - Each58151-103f1422b33-0f9f-435d-ada5-2cef24d2387412024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-103DETROL LA (TOLTERODINE TARTRATE) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]3Current NDC, 3 package rows20250202_d7274947-4f88-47ee-a39f-bd5ac46fcf8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855184Detrol LA 2 MG 24HR Extended Release Oral CapsulePSNd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855191Detrol LA 4 MG 24HR Extended Release Oral CapsulePSNd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85518424 HR tolterodine tartrate 2 MG Extended Release Oral Capsule [Detrol]SBDd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85519124 HR tolterodine tartrate 4 MG Extended Release Oral Capsule [Detrol]SBDd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85518424 HR Detrol 2 MG Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
85519124 HR Detrol LA 4 MG Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855184Detrol LA 2 MG 24 HR Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855191Detrol LA 4 MG 24 HR Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYd7274947-4f88-47ee-a39f-bd5ac46fcf8d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58151-103-0558151010305500 in 1 BOTTLEHistorical
58151-103-775815101037790 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-77) 2024-01-102026-07-31NoNoHistorical
58151-103-935815101039330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-103-93) 2024-01-102026-07-31NoNoHistorical