FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
0093-2056
11-digit product format
000932056
Labeler code
0093
Product ID
0093-2056_5c48e761-a899-432a-a4d6-40b900d9eb48
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA Inc
Application
NDA020771
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-05-11
Marketing end
0000-00-00
Substance
TOLTERODINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Muscarinic Antagonist [EPC],Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0093-2056DDiscontinued by firm2026-07-31
excluded packagepackage0093-20560093-2056-05DDiscontinued by firm2026-07-31
excluded packagepackage0093-20560093-2056-06DDiscontinued 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
N020771-001DETROLTOLTERODINE TARTRATE1MGTABLET / ORALABRLD1998-03-25
N020771-002DETROLTOLTERODINE TARTRATE2MGTABLET / ORALABRLD, RS1998-03-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020771-001AB
N020771-002AB

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 22:54:322026-06N020771-001DETROL1MGTABLET / ORALABRLD1998-03-25a50c72e98297…
2026-08-01 22:54:322026-06N020771-002DETROL2MGTABLET / ORALABRLD, RS1998-03-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N020771-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N020771-002AB1a50c72e98297…

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 TARTRATEMylan Pharmaceuticals Inc.9e432622-2e6f-4cf8-892f-510288dd50f22024-09-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771
DetrolTOLTERODINE TARTRATEViatris Specialty LLC41eb00d2-64e3-4ec9-8732-4bfc81b041802023-02-15Warnings, Adverse reactionsExact identifier
application applno (NDA): 020771
application number: NDA020771

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-2056-05EA - Each0093-2056e940de23-d646-43bb-b27c-8dc35d0baca112012-07-24
0093-2056-06EA - Each0093-2056cc740acb-1c2b-4e95-96f8-14adfbb19a0812012-07-24
0093-2056-42EA - Each0093-2056bcbd09b5-9204-4113-818f-5a7df97e18e912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
SODIUM STARCH GLYCOLATE TYPE B POTATOINACTIVE INGREDIENT27NA468985TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC]8