FDA.reportPublic FDA data

TOLTERODINE TARTRATE

Product NDC
0904-6593
11-digit product format
009046593
Labeler code
0904
Product ID
0904-6593_733b861b-8712-436e-a406-e14b640fd04c
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
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
TOLTERODINE TARTRATE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 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
0904-6593-04TOLTERODINE TARTRATE30 in 1 CARTONCAPSULE, EXTENDED RELEASE309
0904-6593-04TOLTERODINE TARTRATE1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6593-04EA - Each0904-659315143612-785b-4b57-b235-1636c69bff2012017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6593TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Current NDC, Legacy 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
0904-6593-040090465930430 BLISTER PACK in 1 CARTON (0904-6593-04) / 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK30 blister pack2015-08-112026-07-31NoNoCurrent