FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
50090-5995
Requested package NDC
50090-5995-0
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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-599550090-5995-0IInactivated by FDA2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079141-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22
A079141-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A079141-001AB
A079141-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A079141-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…
2026-08-01 22:54:322026-06A079141-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079141-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079141-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine TartrateTOLTERODINE TARTRATEA-S Medication Solutionsfd6c8b3d-a52a-4418-aa9c-0297db6c08072026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.973f98b5-4e8a-42d9-ac69-d4333d21c3622024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141

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