FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
71205-319
11-digit product format
712050319
Labeler code
71205
Product ID
71205-319_df5371c1-a1d3-4e6d-af7a-17cb46d7653d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077006
Marketing category
ANDA
Marketing start
2015-11-01
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
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
A077006-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23
A077006-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077006-001AB
A077006-002AB

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 22:54:322026-06A077006-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2015-02-23a50c72e98297…
2026-08-01 22:54:322026-06A077006-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2015-02-23a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077006-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077006-002AB1a50c72e98297…

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 TARTRATETeva Pharmaceuticals USA, Inc.d27e25b5-5d02-419f-b098-41fb162c58722022-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006
Tolterodine TartrateTOLTERODINE TARTRATEProficient Rx LPb77f9893-a422-423a-bb27-527377ade36d2019-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077006
application number: ANDA077006
ndc (product): 71205-319

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLTERODINE TARTRATE1 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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b77f9893-a422-423a-bb27-527377ade36dAvailable 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
71205-319-30Tolterodine Tartrate30 in 1 BOTTLETABLET, FILM COATED302
71205-319-60Tolterodine Tartrate60 in 1 BOTTLETABLET, FILM COATED602
71205-319-90Tolterodine Tartrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-319-90EA - Each71205-319096c7479-d30a-4f5e-b17e-c8b0cd460e3912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-319TOLTERODINE TARTRATE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191005_b77f9893-a422-423a-bb27-527377ade36d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855178tolterodine tartrate 1 MG Oral TabletPSNb77f9893-a422-423a-bb27-527377ade36d2
855178tolterodine tartrate 1 MG Oral TabletSCDb77f9893-a422-423a-bb27-527377ade36d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-319-307120503193030 TABLET, FILM COATED in 1 BOTTLE (71205-319-30) 2019-09-010000-00-00NoNoCurrent
71205-319-607120503196060 TABLET, FILM COATED in 1 BOTTLE (71205-319-60) 2019-09-010000-00-00NoNoCurrent
71205-319-907120503199090 TABLET, FILM COATED in 1 BOTTLE (71205-319-90) 2019-09-010000-00-00NoNoCurrent