Home NDC 31722-805 Tolterodine Tartrate
Product NDC 31722-805
11-digit product format 317220805
Labeler code 31722
Product ID 31722-805_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 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 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.
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 2026-08-01 22:54:32 2026-06 A204397-001 TOLTERODINE TARTRATE 1MG TABLET / ORAL AB 2021-08-02 a50c72e98297…2026-08-01 22:54:32 2026-06 A204397-002 TOLTERODINE TARTRATE 2MG TABLET / ORAL AB 2021-08-02 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A204397-001 AB 1 a50c72e98297…2026-08-01 22:54:32 2026-06 A204397-002 AB 1 a50c72e98297…
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 31722-805-01 Tolterodine Tartrate 10 in 1 CARTON TABLET, FILM COATED 10 1 31722-805-02 Tolterodine Tartrate 10 in 1 CARTON TABLET, FILM COATED 10 1 31722-805-05 Tolterodine Tartrate 500 in 1 BOTTLE TABLET, FILM COATED 500 1 31722-805-31 Tolterodine Tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 31722-805-32 Tolterodine Tartrate 10 in 1 BLISTER PACK TABLET, FILM COATED 10 1 31722-805-60 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 31722-805 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
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 31722-805-01 31722080501 10 BLISTER PACK in 1 CARTON (31722-805-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-31) 10 blister pack 2021-08-02 0000-00-00 No No Current 31722-805-02 31722080502 10 BLISTER PACK in 1 CARTON (31722-805-02) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-805-32) 10 blister pack 2021-08-02 0000-00-00 No No Current 31722-805-05 31722080505 500 TABLET, FILM COATED in 1 BOTTLE (31722-805-05) 2021-08-02 0000-00-00 No No Current 31722-805-31 31722080531 10 in 1 BLISTER PACK Historical 31722-805-32 31722080532 10 in 1 BLISTER PACK Historical 31722-805-60 31722080560 60 TABLET, FILM COATED in 1 BOTTLE (31722-805-60) 2021-08-02 0000-00-00 No No Current