Home NDC 71610-812 Trospium Chloride
Product NDC 71610-812
11-digit product format 716100812
Labeler code 71610
Product ID 71610-812_1523cfdd-99a0-6b9e-e063-6394a90afd3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trospium Chloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aphena Pharma Solutions - Tennessee, LLC
Application ANDA204945
Marketing category ANDA
Marketing start 2015-11-16
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 42 .
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 A204945-001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204945-001 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.
Product history page 1 of 2 · 42 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 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204945-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB 2016-08-30 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
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 71610-812-87 Trospium Chloride 2400 in 1 BOTTLE TABLET, FILM COATED 2400 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71610-812 TROSPIUM CHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ] 1 Current NDC, 1 package rows 20240405_1523cb4c-3a52-6c18-e063-6394a90a396f.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 · 5 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 71610-812-87 71610081287 2400 TABLET, FILM COATED in 1 BOTTLE (71610-812-87) 2024-03-28 No No Current