FDA.reportPublic FDA data

Tolterodine tartrate

Product NDC
70518-2794
11-digit product format
705182794
Labeler code
70518
Product ID
70518-2794_d7103198-f80e-3714-e053-2a95a90a0af2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203409
Marketing category
ANDA
Marketing start
2020-06-23
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-2794DDiscontinued by firm2026-07-31
excluded packagepackage70518-279470518-2794-0DDiscontinued by firm2026-07-31

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
A203409-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2015-08-31
A203409-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2015-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203409-001AB
A203409-002AB

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 22:54:322026-06A203409-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2015-08-31a50c72e98297…
2026-08-01 22:54:322026-06A203409-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2015-08-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203409-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203409-002AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tolterodine tartrateTOLTERODINE TARTRATEMacleods Pharmaceuticals Limited3f2291c3-7e3c-41be-afa6-ef73ce896e302022-11-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203409
application number: ANDA203409

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2794-02022-02-02C16284748780-1d6a99b39-dff1-a426-e053-dadaa90af4c2Tolterodine Tartrate Tablets
70518-2794-02022-01-28C16284748780-1d6a99b39-dff1-a426-e053-dadaa90af4c2Tolterodine Tartrate Tablets

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2794-07051827940028 TABLET, FILM COATED in 1 BLISTER PACK (70518-2794-0) 2020-06-230000-00-00NoNoCurrent