Home NDC 50090-5994-0 TROSPIUM CHLORIDE
Product NDC 50090-5994
Requested package NDC 50090-5994-0
11-digit product format 500905994
Labeler code 50090
Product ID 50090-5994_88490ba7-995b-4bcc-85a0-9a68f31b68a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TROSPIUM CHLORIDE
Dosage form CAPSULE, EXTENDED RELEASE
Route ORAL
Labeler A-S Medication Solutions
Application ANDA214760
Marketing category ANDA
Marketing start 2021-06-21
Marketing end 0000-00-00
Substance TROSPIUM CHLORIDE
Active strength 60 mg/1
Pharmacologic classes Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A214760-001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A214760-001 AB
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 2026-02-19 14:30 UTC 2026-02 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214760-001 TROSPIUM CHLORIDE 60MG CAPSULE, EXTENDED RELEASE / ORAL AB 2021-04-30 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-5994-0 50090599400 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5994-0) 2022-06-10 0000-00-00 No No Current