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

Additional Listing Data#

Finished product
Yes
Brand name base
Detrol LA

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 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
58151-103-05Detrol 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