FDA.reportPublic FDA data

Tolterodine tartrate

Product NDC
33342-098
11-digit product format
333420098
Labeler code
33342
Product ID
33342-098_fa641ff6-005b-47c5-bade-8709129d7ac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA203409
Marketing category
ANDA
Marketing start
2020-10-08
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
2026-12-31
Current FDA listing
Yes

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
ndc (product): 33342-098

Additional Listing Data#

Finished product
Yes
Brand name base
Tolterodine tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5T619TQR3RInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855178Internal RxNorm lookup
855194Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3f2291c3-7e3c-41be-afa6-ef73ce896e30Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-098-09Tolterodine tartrate60 in 1 BOTTLETABLET, FILM COATED604
33342-098-12Tolterodine tartrate10 in 1 CARTONTABLET, FILM COATED104
33342-098-12Tolterodine tartrate10 in 1 BLISTER PACKTABLET, FILM COATED104
33342-098-15Tolterodine tartrate500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-098-09EA - Each33342-098c2993d5c-3c4f-40b1-a821-1901b2e591cb12016-07-19
33342-098-15EA - Each33342-0987893e27a-8240-4161-966b-cefcb815bb9812016-07-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-098TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]4Current NDC, Legacy NDC, 4 package rows20221126_3f2291c3-7e3c-41be-afa6-ef73ce896e30.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSN3f2291c3-7e3c-41be-afa6-ef73ce896e304
855194tolterodine tartrate 2 MG Oral TabletPSN3f2291c3-7e3c-41be-afa6-ef73ce896e304
855178tolterodine tartrate 1 MG Oral TabletSCD3f2291c3-7e3c-41be-afa6-ef73ce896e304
855194tolterodine tartrate 2 MG Oral TabletSCD3f2291c3-7e3c-41be-afa6-ef73ce896e304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-098-093334200980960 TABLET, FILM COATED in 1 BOTTLE (33342-098-09) 2020-10-080000-00-00NoNoCurrent
33342-098-123334200981210 BLISTER PACK in 1 CARTON (33342-098-12) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2020-10-080000-00-00NoNoCurrent
33342-098-1533342009815500 TABLET, FILM COATED in 1 BOTTLE (33342-098-15) 2020-10-080000-00-00NoNoCurrent