Home NDC 59762-0800-2 Tolterodine Tartrate
Product NDC 59762-0800
Requested package NDC 59762-0800-2
11-digit product format 597620800
Labeler code 59762
Product ID 59762-0800_ed9b3b5f-bd2f-4bcd-8930-5c2230512f72
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Greenstone LLC
Application NDA020771
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-01-21
Marketing end 0000-00-00
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 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N020771-001 DETROL TOLTERODINE TARTRATE 1MG TABLET / ORAL AB RLD 1998-03-25 N020771-002 DETROL TOLTERODINE TARTRATE 2MG TABLET / ORAL AB RLD, RS 1998-03-25
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 · 86 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 2026-09-14 22:38:34 2026-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59762-0800-2 Tolterodine Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 12 59762-0800-6 Tolterodine Tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 12
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 [GREENSTONE LLC] 4 TOLTERODINE ACTIVE MOIETY WHE7A56U7K TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TOLTERODINE TARTRATE TABLET, FILM COATED [GREENSTONE LLC] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-0800 TOLTERODINE TARTRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.] 11 Legacy NDC, 2 package rows 20250504_9e432622-2e6f-4cf8-892f-510288dd50f2.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Detrol TOLTERODINE TARTRATE Viatris Specialty LLC 41eb00d2-64e3-4ec9-8732-4bfc81b04180 2023-02-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 020771 application number: NDA020771
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 59762-0800-2 59762080002 60 TABLET, FILM COATED in 1 BOTTLE (59762-0800-2) 2014-01-21 0000-00-00 No No Current