FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
50090-5995
11-digit product format
500905995
Labeler code
50090
Product ID
50090-5995_71f32299-c1c7-41b2-ab34-b82948bb79a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA079141
Marketing category
ANDA
Marketing start
2017-03-20
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5995-02024-01-30C16284748780-11030e365-48b8-111a-e063-dadaa90a10e2These 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
50090-5995-0Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5995-0EA - Each50090-599582b7d1fe-1801-411a-9ce3-f1b76214ee3212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5995TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20220616_cff7e184-8f72-4cec-a453-6c9fc0f01382.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNcff7e184-8f72-4cec-a453-6c9fc0f013821
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDcff7e184-8f72-4cec-a453-6c9fc0f013821
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYcff7e184-8f72-4cec-a453-6c9fc0f013821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5995-05009059950090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5995-0) 2022-06-100000-00-00NoNoCurrent