FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
60687-319
11-digit product format
606870319
Labeler code
60687
Product ID
60687-319_447233c1-c996-9569-e063-6294a90a30be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA203016
Marketing category
ANDA
Marketing start
2017-08-14
Substance
TOLTERODINE TARTRATE
Active strength
2 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine Tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5T619TQR3R
Rxcui855182, 855189

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
60687-319-11Tolterodine Tartrate1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE17
60687-319-21Tolterodine Tartrate30 in 1 BOX, UNIT-DOSECAPSULE, EXTENDED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-319-11EA - Each60687-3195dd33c3b-c9f4-4266-9242-bd9da9574ff212017-09-11
60687-319-21EA - Each60687-31962f475d5-17b3-4ed5-8dcd-777293dd6c7f12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-319TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]6Current NDC, Legacy NDC, 2 package rows20241122_8cd23ff7-71ba-4391-95bd-a3a7f347713d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN8cd23ff7-71ba-4391-95bd-a3a7f347713d7
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD8cd23ff7-71ba-4391-95bd-a3a7f347713d7
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY8cd23ff7-71ba-4391-95bd-a3a7f347713d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-319-11606870319111 in 1 BLISTER PACKHistorical
60687-319-216068703192130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-319-21) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (60687-319-11) 30 blister pack2017-08-140000-00-00NoNoCurrent