Home NDC 70518-4768 Trospium Chloride
Product NDC 70518-4768
11-digit product format 705184768
Labeler code 70518
Product ID 70518-4768_5d54a88e-becb-92f5-e063-6394a90abc3a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trospium Chloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA091575
Marketing category ANDA
Marketing start 2026-10-08
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A091575-001 TROSPIUM CHLORIDE TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091575-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Trospium Chloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROSPIUM CHLORIDE 20 mg/1
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 Units Marketing start Sample Exclude flag Status 70518-4768-0 70518476800 100 POUCH in 1 BOX (70518-4768-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4768-1) 100 pouch 2026-10-08 No No Current