Home NDC 0093-0010 Tolterodine Tartrate
Product NDC 0093-0010
11-digit product format 000930010
Labeler code 0093
Product ID 0093-0010_2f429822-d6d2-43c0-9aaf-1270b3e92a2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals USA, Inc.
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077006-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 A077006-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077006-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-02-23 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A077006-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-02-23 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tolterodine Tartrate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOLTERODINE TARTRATE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 5T619TQR3R Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855178 Internal RxNorm lookup 855194 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0093-0010-05 Tolterodine Tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 4 0093-0010-06 Tolterodine Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOLTERODINE TARTRATE ACTIVE INGREDIENT 5T619TQR3R TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 TOLTERODINE ACTIVE MOIETY WHE7A56U7K TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 SODIUM STEARYL FUMARATE INACTIVE INGREDIENT 7CV7WJK4UI TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA INC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0093-0010 TOLTERODINE TARTRATE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20221019_d27e25b5-5d02-419f-b098-41fb162c5872.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0093-0010-05 00093001005 500 in 1 BOTTLE Historical 0093-0010-06 00093001006 60 TABLET, FILM COATED in 1 BOTTLE (0093-0010-06) 2015-11-01 0000-00-00 No No Current