TOLTERODINE TARTRATE

Product NDC
0904-6592
11-digit product format
009046592
Labeler code
0904
Product ID
0904-6592_51952461-8eb1-453b-b923-4fcaf6b78b83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLTERODINE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA203016
Marketing category
ANDA
Marketing start
2015-08-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

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
0904-6592-04TOLTERODINE TARTRATE1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE19
0904-6592-04TOLTERODINE TARTRATE30 in 1 CARTONCAPSULE, EXTENDED RELEASE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6592-04EA - Each0904-659298186b68-020e-445a-9016-20dedbab486b12017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6592TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Legacy NDC, 2 package rows20250515_da9423b5-00ab-46fc-8959-3db3c0a0bc6d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6592-040090465920430 BLISTER PACK in 1 CARTON (0904-6592-04) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2015-08-110000-00-00NoNoCurrent