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 42.

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11caaa826d4ba7…
2026-08-18 06:07:402026-07A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11d06236e962d9…
2024-10-29 15:01 UTC2024-10A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-118072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-114b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203016-001TOLTERODINE TARTRATE2MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203016-002TOLTERODINE TARTRATE4MGCAPSULE, EXTENDED RELEASE / ORALAB2015-08-11bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203016-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203016-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203016-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203016-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203016-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203016-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203016-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203016-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203016-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203016-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203016-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203016-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203016-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203016-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203016-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203016-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203016-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203016-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203016-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203016-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203016-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203016-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203016-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203016-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203016-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203016-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203016-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203016-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203016-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203016-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203016-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203016-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203016-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203016-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203016-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203016-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203016-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203016-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203016-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203016-002AB1bb7c543d1eb4…

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#

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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

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