FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
31722-806
11-digit product format
317220806
Labeler code
31722
Product ID
31722-806_c9a8a649-3330-59a0-e053-2995a90ad3c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA204397
Marketing category
ANDA
Marketing start
2021-08-02
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
A204397-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2021-08-02
A204397-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2021-08-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204397-001AB
A204397-002AB

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 22:54:322026-06A204397-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2021-08-02a50c72e98297…
2026-08-01 22:54:322026-06A204397-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2021-08-02a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A204397-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A204397-002AB1a50c72e98297…

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 TARTRATECamber Pharmaceuticals, Inc.f67fce7c-69d3-42ae-8c1d-2e26fd4d74152021-08-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204397
application number: ANDA204397
ndc (product): 31722-806

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
f67fce7c-69d3-42ae-8c1d-2e26fd4d7415Available 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
31722-806-01Tolterodine Tartrate10 in 1 CARTONTABLET, FILM COATED101
31722-806-02Tolterodine Tartrate10 in 1 CARTONTABLET, FILM COATED101
31722-806-05Tolterodine Tartrate500 in 1 BOTTLETABLET, FILM COATED5001
31722-806-31Tolterodine Tartrate10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-806-32Tolterodine Tartrate10 in 1 BLISTER PACKTABLET, FILM COATED101
31722-806-60Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-806-05EA - Each31722-8067896ea6c-b894-4d7f-8236-330348bcc95712022-09-12
31722-806-60EA - Each31722-806d538cc94-09bb-4691-84cc-d9be8a4bec2612022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-806TOLTERODINE TARTRATE (TOLTERODINE TARTRATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 6 package rows20210817_f67fce7c-69d3-42ae-8c1d-2e26fd4d7415.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSNf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855194tolterodine tartrate 2 MG Oral TabletPSNf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855178tolterodine tartrate 1 MG Oral TabletSCDf67fce7c-69d3-42ae-8c1d-2e26fd4d74151
855194tolterodine tartrate 2 MG Oral TabletSCDf67fce7c-69d3-42ae-8c1d-2e26fd4d74151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-806-013172208060110 BLISTER PACK in 1 CARTON (31722-806-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-31) 10 blister pack2021-08-020000-00-00NoNoCurrent
31722-806-023172208060210 BLISTER PACK in 1 CARTON (31722-806-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-32) 10 blister pack2021-08-020000-00-00NoNoCurrent
31722-806-0531722080605500 TABLET, FILM COATED in 1 BOTTLE (31722-806-05) 2021-08-020000-00-00NoNoCurrent
31722-806-313172208063110 in 1 BLISTER PACKHistorical
31722-806-323172208063210 in 1 BLISTER PACKHistorical
31722-806-603172208066060 TABLET, FILM COATED in 1 BOTTLE (31722-806-60) 2021-08-020000-00-00NoNoCurrent