FDA.reportPublic FDA data

Detrol LA

Product NDC
58151-104
11-digit product format
581510104
Labeler code
58151
Product ID
58151-104_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
2024-03-20
Marketing end
2026-07-31
Substance
TOLTERODINE TARTRATE
Active strength
4 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Detrol LA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855182, 855184, 855189, 855191

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
58151-104-05Detrol LA500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5005
58151-104-77Detrol LA90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905
58151-104-93Detrol LA30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-104-77EA - Each58151-104ad7d1c5f-926e-4b47-ac47-2e28a723d4aa12024-04-05
58151-104-93EA - Each58151-104c376f409-a79e-4e4b-a276-1b2d0e206c4012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-104DETROL 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
58151-104-0558151010405500 in 1 BOTTLEHistorical
58151-104-775815101047790 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-77) 2024-03-202026-07-31NoNoHistorical
58151-104-935815101049330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-104-93) 2024-03-202026-07-31NoNoHistorical