Home NDC 31722-806 Tolterodine Tartrate
Product NDC 31722-806
11-digit product format 317220806
Labeler code 31722
Product ID 31722-806_c9a8a649-3330-59a0-e053-2995a90ad3c3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine Tartrate
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Camber Pharmaceuticals, Inc.
Application ANDA204397
Marketing category ANDA
Marketing start 2021-08-02
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 2026-12-31
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 A204397-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 A204397-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02
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 · 68 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 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 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 · 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 31722-806-01 Tolterodine Tartrate 10 in 1 CARTON TABLET, FILM COATED 10 1 31722-806-02 Tolterodine Tartrate 10 in 1 CARTON TABLET, FILM COATED 10 1 31722-806-05 Tolterodine Tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 1 31722-806-31 Tolterodine Tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 31722-806-32 Tolterodine Tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 31722-806-60 Tolterodine Tartrate 60 in 1 BOTTLE TABLET, FILM COATED 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 31722-806 TOLTERODINE TARTRATE (TOLTERODINE TARTRATE) TABLET, FILM COATED [CAMBER PHARMACEUTICALS, INC.] 1 Current NDC, Legacy NDC, 6 package rows 20210817_f67fce7c-69d3-42ae-8c1d-2e26fd4d7415.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 Units Marketing start Marketing end Sample Exclude flag Status 31722-806-01 31722080601 10 BLISTER PACK in 1 CARTON (31722-806-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-31) 10 blister pack 2021-08-02 0000-00-00 No No Current 31722-806-02 31722080602 10 BLISTER PACK in 1 CARTON (31722-806-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-806-32) 10 blister pack 2021-08-02 0000-00-00 No No Current 31722-806-05 31722080605 500 TABLET, FILM COATED in 1 BOTTLE (31722-806-05) 2021-08-02 0000-00-00 No No Current 31722-806-31 31722080631 10 in 1 BLISTER PACK Historical 31722-806-32 31722080632 10 in 1 BLISTER PACK Historical 31722-806-60 31722080660 60 TABLET, FILM COATED in 1 BOTTLE (31722-806-60) 2021-08-02 0000-00-00 No No Current