FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
68151-3549
11-digit product format
681513549
Labeler code
68151
Product ID
68151-3549_8216b360-5b06-467e-87a2-733d16448f85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Carilion Materials Management
Application
ANDA077006
Marketing category
ANDA
Marketing start
2015-11-01
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
E
Listing certified through
2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68151-3549IInactivated by FDA2026-07-31
excluded packagepackage68151-354968151-3549-1IInactivated 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
A077006-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23
A077006-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077006-001AB
A077006-002AB

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 22:54:322026-06A077006-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23a50c72e98297…
2026-08-01 22:54:322026-06A077006-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077006-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077006-002AB1a50c72e98297…

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 TARTRATETeva Pharmaceuticals USA, Inc.d27e25b5-5d02-419f-b098-41fb162c58722022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006
Tolterodine TartrateTOLTERODINE TARTRATEProficient Rx LPb77f9893-a422-423a-bb27-527377ade36d2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006

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
68151-3549-12020-01-31C16284748780-19d75b9d0-6f70-f424-e053-dadaa90a57ceTOLTERODINE TARTRATE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68151-3549-1Tolterodine Tartrate1 in 1 BLISTER PACKTABLET, FILM COATED12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68151-3549TOLTERODINE TARTRATE TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2Legacy NDC, 1 package rows20171227_51fff553-ccae-449c-a82a-c164de819943.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855194tolterodine tartrate 2 MG Oral TabletPSN51fff553-ccae-449c-a82a-c164de8199432
855194tolterodine tartrate 2 MG Oral TabletSCD51fff553-ccae-449c-a82a-c164de8199432

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68151-3549-1681513549011 in 1 BLISTER PACKHistorical