FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
68151-4247
11-digit product format
681514247
Labeler code
68151
Product ID
68151-4247_0130f584-6aea-468e-ac9e-5b64f6ddc195
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Carilion Materials Management
Application
NDA021228
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-01-02
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
E
Listing certified through
2018-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68151-4247-12020-01-31C16284748780-19d75b9d0-6efb-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use tolterodine tartrate extended-release capsules safely and effectively. See full prescribing information for tolterodine tartrate extended-release capsules. Tolterodine tartrate extended-release capsules For oral administration Initial U.S. Approval: December 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-4247-1Tolterodine Tartrate1 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-4247TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [CARILION MATERIALS MANAGEMENT]4Legacy NDC, 1 package rows20171227_09b4ec42-9b47-4a6c-b219-7c5dcda35ac5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY09b4ec42-9b47-4a6c-b219-7c5dcda35ac54
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY09b4ec42-9b47-4a6c-b219-7c5dcda35ac54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-4247-1681514247011 in 1 BLISTER PACKHistorical