TOLTERODINE TARTRATE

Product NDC
10135-706
11-digit product format
101350706
Labeler code
10135
Product ID
10135-706_ecacf984-65cf-8a10-e053-2a95a90a0f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TOLTERODINE TARTRATE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA210775
Marketing category
ANDA
Marketing start
2020-08-01
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10135-706IInactivated by FDA2026-08-17
excluded packagepackage10135-70610135-706-05IInactivated by FDA2026-08-17
excluded packagepackage10135-70610135-706-60IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 45 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10135-706-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10135-706-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-706-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10135-706-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10135-706-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10135-706-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10135-706-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10135-706-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10135-706-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10135-706-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10135-706-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10135-706-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10135-706-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10135-706-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10135-706-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10135-706-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10135-706-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10135-706-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10135-706-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10135-706-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10135-706-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10135-706-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10135-706-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10135-706-05557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10135-706-608af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10135-706-058af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10135-706-60834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10135-706-05834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10135-706-601332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10135-706-051332a3947898…d4bfe170f9cd…

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
A210775-001TOLTERODINE TARTRATETOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30
A210775-002TOLTERODINE TARTRATETOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A210775-001AB
A210775-002AB

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 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30caaa826d4ba7…
2026-08-18 06:07:402026-07A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210775-001TOLTERODINE TARTRATE1MGTABLET / ORALAB2019-12-30782e0a99824c…
2021-12-28 21:50 UTC2021-12A210775-002TOLTERODINE TARTRATE2MGTABLET / ORALAB2019-12-30782e0a99824c…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A210775-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A210775-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A210775-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A210775-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210775-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A210775-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A210775-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A210775-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210775-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A210775-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210775-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A210775-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210775-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A210775-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210775-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A210775-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210775-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A210775-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210775-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A210775-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A210775-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A210775-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210775-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A210775-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210775-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A210775-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210775-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A210775-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A210775-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A210775-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210775-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A210775-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A210775-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A210775-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A210775-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A210775-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A210775-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A210775-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A210775-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A210775-002AB1782e0a99824c…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b480943b-5b5a-aac0-c5ca-c22f479ac1a1Product name820250325
a932c194-3a9e-a7d8-8961-eb5843129c16Product name620220210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-706-052024-01-30C16284748780-11030e365-649e-111a-e063-dadaa90a10e2Tolterodine Tartrate Tablets
10135-706-602024-01-30C16284748780-11030e365-649e-111a-e063-dadaa90a10e2Tolterodine Tartrate Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-706-05TOLTERODINE TARTRATE500 in 1 BOTTLETABLET, EXTENDED RELEASE5004
10135-706-60TOLTERODINE TARTRATE60 in 1 BOTTLETABLET, EXTENDED RELEASE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-706TOLTERODINE TARTRATE TABLET, EXTENDED RELEASE [MARLEX PHARMACEUTICALS INC]4Legacy NDC, 2 package rows20221105_25ce804d-b9cf-4ca7-9ec3-942eb79c0bd1.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10135-706-0510135070605500 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-706-05) 2020-08-010000-00-00NoNoCurrent
10135-706-601013507066060 TABLET, EXTENDED RELEASE in 1 BOTTLE (10135-706-60) 2020-08-010000-00-00NoNoCurrent