FDA.reportPublic FDA data

TOLTERODINE TARTRATE

Product NDC
13668-189
11-digit product format
136680189
Labeler code
13668
Product ID
13668-189_de456fdd-b0a2-4b65-b926-bb9948fde276
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLTERODINE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA203016
Marketing category
ANDA
Marketing start
2015-08-11
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
2027-12-31
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
A203016-001TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11
A203016-002TOLTERODINE TARTRATETOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203016-001AB
A203016-002AB

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 22:54:322026-06A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11a50c72e98297…
2026-08-01 22:54:322026-06A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203016-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203016-002AB1a50c72e98297…

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 TARTRATETOLTERODINETorrent Pharmaceuticals Limiteddb6e0b6d-0ce5-41d7-881f-881c11f530a42026-02-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203016
application number: ANDA203016
ndc (product): 13668-189
Tolterodine TartrateTOLTERODINEAmerican Health Packaging8cd23ff7-71ba-4391-95bd-a3a7f347713d2025-11-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203016
application number: ANDA203016

Additional Listing Data#

Finished product
Yes
Brand name base
TOLTERODINE TARTRATE
Listing expiration
2027-12-31

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
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
db6e0b6d-0ce5-41d7-881f-881c11f530a4Available 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
13668-189-05TOLTERODINE TARTRATE500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
13668-189-30TOLTERODINE TARTRATE30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
13668-189-74TOLTERODINE TARTRATE100 in 1 CARTONCAPSULE, EXTENDED RELEASE10010
13668-189-90TOLTERODINE TARTRATE90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-189-05EA - Each13668-189b10b0d7a-70b5-4f09-8377-af2a893bf1e812015-09-10
13668-189-30EA - Each13668-18938fda7e9-162b-4040-a663-0d096335824c12015-09-10
13668-189-90EA - Each13668-189d99db53e-9294-4145-b2f5-3d3627e1851012015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLTERODINE TARTRATEACTIVE INGREDIENT5T619TQR3RTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
TOLTERODINEACTIVE MOIETYWHE7A56U7KTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
GELATININACTIVE INGREDIENT2G86QN327LTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
SUCROSEINACTIVE INGREDIENTC151H8M554TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1
TALCINACTIVE INGREDIENT7SEV7J4R1UTOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-189TOLTERODINE TARTRATE (TOLTERODINE) CAPSULE, EXTENDED RELEASE [TORRENT PHARMACEUTICALS LIMITED]8Current NDC, Legacy NDC, 4 package rows20250509_db6e0b6d-0ce5-41d7-881f-881c11f530a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNdb6e0b6d-0ce5-41d7-881f-881c11f530a410
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNdb6e0b6d-0ce5-41d7-881f-881c11f530a410
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDdb6e0b6d-0ce5-41d7-881f-881c11f530a410
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDdb6e0b6d-0ce5-41d7-881f-881c11f530a410
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYdb6e0b6d-0ce5-41d7-881f-881c11f530a410
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYdb6e0b6d-0ce5-41d7-881f-881c11f530a410
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSNda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCDda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSYda9423b5-00ab-46fc-8959-3db3c0a0bc6d9
855182tolterodine tartrate 2 MG 24HR Extended Release Oral CapsulePSN8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855189tolterodine tartrate 4 MG 24HR Extended Release Oral CapsulePSN8cd23ff7-71ba-4391-95bd-a3a7f347713d7
85518224 HR tolterodine tartrate 2 MG Extended Release Oral CapsuleSCD8cd23ff7-71ba-4391-95bd-a3a7f347713d7
85518924 HR tolterodine tartrate 4 MG Extended Release Oral CapsuleSCD8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855182tolterodine tartrate 2 MG 24 HR Extended Release Oral CapsuleSY8cd23ff7-71ba-4391-95bd-a3a7f347713d7
855189tolterodine tartrate 4 MG 24 HR Extended Release Oral CapsuleSY8cd23ff7-71ba-4391-95bd-a3a7f347713d7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13668-189-0513668018905500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-05) 2015-08-110000-00-00NoNoCurrent
13668-189-301366801893030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-30) 2015-08-110000-00-00NoNoCurrent
13668-189-7413668018974100 CAPSULE, EXTENDED RELEASE in 1 CARTON (13668-189-74) 2015-08-110000-00-00NoNoCurrent
13668-189-901366801899090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (13668-189-90) 2015-08-110000-00-00NoNoCurrent