Home NDC 68462-461 Trospium Chloride
Product NDC 68462-461
11-digit product format 684620461
Labeler code 68462
Product ID 68462-461_44d944da-d624-4016-a3eb-ce810b62fb17
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trospium Chloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091575
Marketing category ANDA
Marketing start 2010-08-13
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 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 · 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 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…2022-09-29 23:25 UTC 2022-09 A091575-001 TROSPIUM CHLORIDE 20MG TABLET / ORAL AB RS 2010-08-13 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 68462-461-05 Trospium Chloride 500 in 1 BOTTLE TABLET, FILM COATED 500 18 68462-461-10 Trospium Chloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 18 68462-461-30 Trospium Chloride 30 in 1 BOTTLE TABLET, FILM COATED 30 18 68462-461-60 Trospium Chloride 60 in 1 BOTTLE TABLET, FILM COATED 60 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TROSPIUM CHLORIDE ACTIVE INGREDIENT 1E6682427E TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 TROSPIUM ACTIVE MOIETY T4Y8ORK057 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 COPOVIDONE K25-31 INACTIVE INGREDIENT D9C330MD8B TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 POVIDONES INACTIVE INGREDIENT FZ989GH94E TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 SUCROSE INACTIVE INGREDIENT C151H8M554 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 TALC INACTIVE INGREDIENT 7SEV7J4R1U TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-461 TROSPIUM CHLORIDE TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC., USA] 17 Current NDC, Legacy NDC, 4 package rows 20231228_d5c837a4-d1c6-4615-b7ad-27f3162a03aa.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 Marketing end Sample Exclude flag Status 68462-461-05 68462046105 500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05) 2010-08-13 0000-00-00 No No Current 68462-461-10 68462046110 1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) 2023-06-30 No No Current 68462-461-30 68462046130 30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30) 2010-08-13 0000-00-00 No No Current 68462-461-60 68462046160 60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60) 2010-08-13 0000-00-00 No No Current