Home NDC 33342-554 Trospium Chloride
Product NDC 33342-554
11-digit product format 333420554
Labeler code 33342
Product ID 33342-554_4d3cbe46-addd-4a3e-850d-ce502fd5cd26
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trospium Chloride
Dosage form TABLET
Route ORAL
Labeler Macleods Pharmaceuticals Limited
Application ANDA206472
Marketing category ANDA
Marketing start 2024-06-18
Substance TROSPIUM CHLORIDE
Active strength 20 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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A206472-001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206472-001 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 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A206472-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2024-06-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Trospium Chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROSPIUM CHLORIDE 20 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1E6682427E Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 857560 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 33342-554-09 Trospium Chloride 60 in 1 BOTTLE TABLET 60 2 33342-554-39 Trospium Chloride 15 in 1 BLISTER PACK TABLET 15 2 33342-554-39 Trospium Chloride 6 in 1 CARTON TABLET 6 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 33342-554 TROSPIUM CHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED] 2 Current NDC, 3 package rows 20240906_fcb13b21-e4a2-461b-b3cb-0daedc722050.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 Sample Exclude flag Status 33342-554-09 33342055409 60 TABLET in 1 BOTTLE (33342-554-09) 60 tablet 2024-06-18 No No Current 33342-554-39 33342055439 6 BLISTER PACK in 1 CARTON (33342-554-39) / 15 TABLET in 1 BLISTER PACK 6 blister pack 2024-06-18 No No Current