FDA.reportPublic FDA data

TOLTERODINE TARTRATE

Product NDC
10135-707
11-digit product format
101350707
Labeler code
10135
Product ID
10135-707_ecacf984-65cf-8a10-e053-2a95a90a0f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLTERODINE TARTRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210775
Marketing category
ANDA
Marketing start
2020-08-01
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10135-707IInactivated by FDA2026-07-31
excluded packagepackage10135-70710135-707-05IInactivated by FDA2026-07-31
excluded packagepackage10135-70710135-707-60IInactivated by FDA2026-07-31

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210775-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30
A210775-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30

Therapeutic equivalence codes#

Application-product, TE code table
Application-productTE code
A210775-001AB
A210775-002AB

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
10135-707-052024-01-30C16284748780-11030e365-649e-111a-e063-dadaa90a10e2Tolterodine Tartrate Tablets
10135-707-602024-01-30C16284748780-11030e365-649e-111a-e063-dadaa90a10e2Tolterodine Tartrate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-707-05TOLTERODINE TARTRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
10135-707-60TOLTERODINE TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-707TOLTERODINE TARTRATE TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20221105_25ce804d-b9cf-4ca7-9ec3-942eb79c0bd1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-707-0510135070705500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-707-05) 2020-08-010000-00-00NoNoCurrent
10135-707-601013507076060 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-707-60) 2020-08-010000-00-00NoNoCurrent