Home NDC 16571-126 Tolterodine Tartrate
Product NDC 16571-126
11-digit product format 165710126
Labeler code 16571
Product ID 16571-126_d56e7ced-4633-4325-8e3d-166c84c05886
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA204721
Marketing category ANDA
Marketing start 2020-01-24
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 A204721-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 A204721-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24
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 2 · 74 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 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204721-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2020-01-24 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204721-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2020-01-24 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 16571-126-01 Tolterodine Tartrate 100 in 1 BOTTLE TABLET, FILM COATED 100 3 16571-126-06 Tolterodine Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 3 16571-126-50 Tolterodine Tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16571-126 TOLTERODINE TARTRATE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] 2 Current NDC, Legacy NDC, 3 package rows 20200915_b9ba8ad2-27f6-4f18-bd84-73659047910e.zip
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 16571-126-01 16571012601 100 TABLET, FILM COATED in 1 BOTTLE (16571-126-01) 2020-01-24 0000-00-00 No No Current 16571-126-06 16571012606 60 TABLET, FILM COATED in 1 BOTTLE (16571-126-06) 2020-01-24 0000-00-00 No No Current 16571-126-50 16571012650 500 TABLET, FILM COATED in 1 BOTTLE (16571-126-50) 2020-01-24 0000-00-00 No No Current