FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
31722-608
11-digit product format
317220608
Labeler code
31722
Product ID
31722-608_e16012ae-5972-470b-8a22-b0626a029e95
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA206419
Marketing category
ANDA
Marketing start
2017-06-02
Substance
TOLTERODINE TARTRATE
Active strength
4 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
A206419-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2017-12-12
A206419-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2017-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206419-001AB
A206419-002AB

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 22:54:322026-06A206419-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2017-12-12a50c72e98297…
2026-08-01 22:54:322026-06A206419-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2017-12-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A206419-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A206419-002AB1a50c72e98297…

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.e16012ae-5972-470b-8a22-b0626a029e952017-06-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206419
application number: ANDA206419
ndc (product): 31722-608

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE4 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
855182Internal RxNorm lookup
855189Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e16012ae-5972-470b-8a22-b0626a029e95Available 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
31722-608-05Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5001
31722-608-30Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
31722-608-90Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-608-30EA - Each31722-60831445654-a7c8-409c-a567-7de7391a14da12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-608TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC.]1Current NDC, Legacy NDC, 3 package rows20171218_e16012ae-5972-470b-8a22-b0626a029e95.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNe16012ae-5972-470b-8a22-b0626a029e951
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNe16012ae-5972-470b-8a22-b0626a029e951
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDe16012ae-5972-470b-8a22-b0626a029e951
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDe16012ae-5972-470b-8a22-b0626a029e951
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYe16012ae-5972-470b-8a22-b0626a029e951
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYe16012ae-5972-470b-8a22-b0626a029e951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
31722-608-0531722060805500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-05) 2017-06-020000-00-00NoNoCurrent
31722-608-303172206083030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-30) 2017-06-020000-00-00NoNoCurrent
31722-608-903172206089090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-608-90) 2017-06-020000-00-00NoNoCurrent