Home NDC 29300-306 Tolterodine tartrate
Product NDC 29300-306
11-digit product format 293000306
Labeler code 29300
Product ID 29300-306_1d40a6e0-df38-4fd8-bfea-5d19c9d071ab
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tolterodine tartrate
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler Unichem Pharmaceuticals (USA), Inc.
Application ANDA216917
Marketing category ANDA
Marketing start 2024-10-01
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 A216917-001 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 A216917-002 TOLTERODINE TARTRATE TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27
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 2026-08-18 06:07:40 2026-07 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 d06236e962d9…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216917-001 TOLTERODINE TARTRATE 2MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216917-002 TOLTERODINE TARTRATE 4MG CAPSULE, EXTENDED RELEASE / ORAL AB 2024-08-27 a50c72e98297…
Observed Orange Book normalized TE history# 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 855182 Internal RxNorm lookup 855189 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 29300-306-05 Tolterodine tartrate 500 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 500 4 29300-306-13 Tolterodine tartrate 30 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 30 4 29300-306-19 Tolterodine tartrate 90 in 1 BOTTLE CAPSULE, EXTENDED RELEASE 90 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 29300-306 TOLTERODINE TARTRATE CAPSULE, EXTENDED RELEASE [UNICHEM PHARMACEUTICALS (USA), INC.] 4 Current NDC, 3 package rows 20241001_9710ad7b-93c2-4ec1-95ff-597563be4314.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 Marketing start Sample Exclude flag Status 29300-306-05 29300030605 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-05) 2024-10-01 No No Current 29300-306-13 29300030613 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-13) 2024-10-01 No No Current 29300-306-19 29300030619 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (29300-306-19) 2024-10-01 No No Current