Home NDC 33342-097-15 Tolterodine tartrate
Product NDC 33342-097
Requested package NDC 33342-097-15
11-digit product format 333420097
Labeler code 33342
Product ID 33342-097_fa641ff6-005b-47c5-bade-8709129d7ac9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA203409
Marketing category ANDA
Marketing start 2020-10-08
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 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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A203409-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 A203409-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A203409-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2015-08-31 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A203409-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2015-08-31 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 33342-097-09 Tolterodine tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 4 33342-097-12 Tolterodine tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4 33342-097-12 Tolterodine tartrate 10 in 1 CARTON TABLET, FILM COATED 10 4 33342-097-15 Tolterodine tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 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 [MACLEODS PHARMACEUTICALS LIMITED] 1 TOLTERODINE ACTIVE MOIETY WHE7A56U7K TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 COLLOIDAL SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 DIBASIC CALCIUM PHOSPHATE DIHYDRATE INACTIVE INGREDIENT O7TSZ97GEP TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-097 TOLTERODINE TARTRATE TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED] 4 Current NDC, Legacy NDC, 4 package rows 20221126_3f2291c3-7e3c-41be-afa6-ef73ce896e30.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 · 1 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 33342-097-15 33342009715 500 TABLET, FILM COATED in 1 BOTTLE (33342-097-15) 2020-10-08 0000-00-00 No No Current