Detrol

Product NDC
58151-099
11-digit product format
581510099
Labeler code
58151
Product ID
58151-099_f27726af-7a9b-45f4-96e0-1e90a5fdcc18
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
tolterodine tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020771
Marketing category
NDA
Marketing start
2024-08-01
Marketing end
2027-01-31
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855178, 855180, 855194, 855195

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
58151-099-91Detrol60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-099-91EA - Each58151-09997cdcc82-6383-4f6a-a405-7218dc2138b112024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-099DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC]5Current NDC, 1 package rows20250201_41eb00d2-64e3-4ec9-8732-4bfc81b04180.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855180Detrol 1 MG Oral TabletPSN41eb00d2-64e3-4ec9-8732-4bfc81b041805
855195Detrol 2 MG Oral TabletPSN41eb00d2-64e3-4ec9-8732-4bfc81b041805
855178tolterodine tartrate 1 MG Oral TabletPSN41eb00d2-64e3-4ec9-8732-4bfc81b041805
855194tolterodine tartrate 2 MG Oral TabletPSN41eb00d2-64e3-4ec9-8732-4bfc81b041805
855180tolterodine tartrate 1 MG Oral Tablet [Detrol]SBD41eb00d2-64e3-4ec9-8732-4bfc81b041805
855195tolterodine tartrate 2 MG Oral Tablet [Detrol]SBD41eb00d2-64e3-4ec9-8732-4bfc81b041805
855178tolterodine tartrate 1 MG Oral TabletSCD41eb00d2-64e3-4ec9-8732-4bfc81b041805
855194tolterodine tartrate 2 MG Oral TabletSCD41eb00d2-64e3-4ec9-8732-4bfc81b041805
855180Detrol 1 MG Oral TabletSY41eb00d2-64e3-4ec9-8732-4bfc81b041805
855195Detrol 2 MG Oral TabletSY41eb00d2-64e3-4ec9-8732-4bfc81b041805

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
58151-099-915815100999160 TABLET, FILM COATED in 1 BOTTLE (58151-099-91) 2024-08-012027-01-31NoNoHistorical