Home NDC 58151-099 Detrol
Product NDC 58151-099
11-digit product format 581510099
Labeler code 58151
Product ID 58151-099_f27726af-7a9b-45f4-96e0-1e90a5fdcc18
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tolterodine tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Viatris Specialty LLC
Application NDA020771
Marketing category NDA
Marketing start 2024-08-01
Marketing end 2027-01-31
Substance TOLTERODINE TARTRATE
Active strength 2 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
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-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 · 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 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…2022-03-09 01:35 UTC 2022-03 N020771-001 DETROL 1MG TABLET / ORAL AB RLD 1998-03-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020771-002 DETROL 2MG TABLET / ORAL AB RLD, RS 1998-03-25 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 Detrol Active Ingredients# Ingredient, Strength table Ingredient Strength TOLTERODINE TARTRATE 2 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 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 855178 Internal RxNorm lookup 855180 Internal RxNorm lookup 855194 Internal RxNorm lookup 855195 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 58151-099-91 Detrol 60 in 1 BOTTLE TABLET, FILM COATED 60 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58151-099 DETROL (TOLTERODINE TARTRATE) TABLET, FILM COATED [VIATRIS SPECIALTY LLC] 5 Current NDC, 1 package rows 20250201_41eb00d2-64e3-4ec9-8732-4bfc81b04180.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 58151-099-91 58151009991 60 TABLET, FILM COATED in 1 BOTTLE (58151-099-91) 2024-08-01 2027-01-31 No No Historical