FDA.reportPublic FDA data

Tolterodine Tartrate

Product NDC
0093-7164
11-digit product format
000937164
Labeler code
0093
Product ID
0093-7164_acae7de6-a2b9-4475-8b25-620c0fa55235
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tolterodine Tartrate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA079141
Marketing category
ANDA
Marketing start
2017-03-20
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
unfinished productproduct0093-7164UNFINISHEDActive or certified unfinished drug listing2026-07-31
unfinished packagepackage0093-71640093-7164-99UNFINISHEDActive or certified unfinished drug listing2026-07-31

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
A079141-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22
A079141-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A079141-001AB
A079141-002AB

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 22:54:322026-06A079141-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…
2026-08-01 22:54:322026-06A079141-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2016-11-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A079141-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A079141-002AB1a50c72e98297…

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 TARTRATEA-S Medication Solutionsfd6c8b3d-a52a-4418-aa9c-0297db6c08072026-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141
Tolterodine TartrateTOLTERODINE TARTRATETeva Pharmaceuticals USA, Inc.973f98b5-4e8a-42d9-ac69-d4333d21c3622024-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079141
application number: ANDA079141
ndc (product): 0093-7164

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
973f98b5-4e8a-42d9-ac69-d4333d21c362Available 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
0093-7164-05Tolterodine Tartrate500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50017
0093-7164-56Tolterodine Tartrate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3017
0093-7164-98Tolterodine Tartrate90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-7164-05EA - Each0093-7164d0ff75a8-1975-4978-a98d-7902ced80cd812017-04-05
0093-7164-56EA - Each0093-7164176e1de5-5e4a-457d-a337-e9743ae02b5612017-04-05
0093-7164-98EA - Each0093-7164e52ae548-f8bd-4a4f-b4e7-fbab42b9193212017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7164TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA, INC.]16Current NDC, Legacy NDC, 3 package rows20250104_973f98b5-4e8a-42d9-ac69-d4333d21c362.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN973f98b5-4e8a-42d9-ac69-d4333d21c36217
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN973f98b5-4e8a-42d9-ac69-d4333d21c36217
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD973f98b5-4e8a-42d9-ac69-d4333d21c36217
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD973f98b5-4e8a-42d9-ac69-d4333d21c36217
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY973f98b5-4e8a-42d9-ac69-d4333d21c36217
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY973f98b5-4e8a-42d9-ac69-d4333d21c36217
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNfd6c8b3d-a52a-4418-aa9c-0297db6c080715
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDfd6c8b3d-a52a-4418-aa9c-0297db6c080715
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYfd6c8b3d-a52a-4418-aa9c-0297db6c080715

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7164-0500093716405500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7164-05) 2017-03-200000-00-00NoNoCurrent
0093-7164-560009371645630 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7164-56) 2017-03-200000-00-00NoNoCurrent
0093-7164-980009371649890 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0093-7164-98) 2017-03-200000-00-00NoNoCurrent
0093-7164-990009371649916129 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0093-7164-99)20-OCT-20Current