Trospium Chloride

Product NDC: 23155-530
11-digit product format: 231550530
Labeler code: 23155
Product ID: 23155-530_bfcf5966-5504-49de-976a-58d2df90d6e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trospium Chloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application: ANDA204945
Marketing category: ANDA
Marketing start: 2016-08-30
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
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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204945-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2016-08-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204945-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204945-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204945-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204945-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204945-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204945-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204945-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204945-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204945-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204945-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204945-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204945-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204945-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204945-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204945-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204945-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204945-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204945-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204945-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204945-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204945-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204945-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204945-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204945-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204945-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204945-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204945-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204945-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204945-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204945-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204945-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204945-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204945-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204945-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204945-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204945-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204945-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204945-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204945-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204945-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trospium Chloride	TROSPIUM CHLORIDE	REMEDYREPACK INC.	48d1b484-ee0a-4d66-9b45-4ba34e65ed13	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204945 application number: ANDA204945
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Chartwell RX, LLC	801f2143-6816-4f34-b65d-16bb2cf07975	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204945 application number: ANDA204945
Trospium Chloride	TROSPIUM CHLORIDE	Major Pharmaceuticals	35ae4d64-4625-4fdd-a2d4-e20b87c56876	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204945 application number: ANDA204945
Trospium Chloride	TROSPIUM CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1523cb4c-3a52-6c18-e063-6394a90a396f	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204945 application number: ANDA204945
Trospium Chloride	TROSPIUM CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	570c3ae7-8011-4944-8935-57d0a66102aa	2023-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204945 application number: ANDA204945 ndc (product): 23155-530

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
570c3ae7-8011-4944-8935-57d0a66102aa	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bfc41181-d174-476d-8a52-4a385ae9213d	Product name	1	20250423
7c473500-2ad1-88f9-e10e-6f8136eda28c	Product name	4	20250226
9151f483-8353-9cd4-427d-86fb1b5ba7ea	Product name	4	20211027

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
23155-530-02	2020-06-02	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004
23155-530-05	2020-06-02	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004
23155-530-06	2020-06-02	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004
23155-530-02	2020-01-31	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004
23155-530-05	2020-01-31	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004
23155-530-06	2020-01-31	C162847	48780-1	9d75b9d0-ba6a-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use Trospium Chloride Tablets safely and effectively. See full prescribing information for Trospium Chloride Tablets. TROSPIUM chloride tablets, USP for oral use Initial U.S. Approval:2004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
23155-530-02	Trospium Chloride	200 in 1 BOTTLE	TABLET, FILM COATED	200	12
23155-530-05	Trospium Chloride	500 in 1 BOTTLE	TABLET, FILM COATED	500	12
23155-530-06	Trospium Chloride	60 in 1 BOTTLE	TABLET, FILM COATED	60	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
23155-530-05	EA - Each	23155-530	abd0e481-2d5e-4dfb-adad-573d493e0d24	1	2017-06-15
23155-530-06	EA - Each	23155-530	7a57cd2a-abca-4f0c-b099-f11e8b30e56e	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
23155-530	TROSPIUM CHLORIDE TABLET, FILM COATED [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]	12	Current NDC, Legacy NDC, 3 package rows	20230822_570c3ae7-8011-4944-8935-57d0a66102aa.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1E6682427E	TROSPIUM CHLORIDE	10405-02-4	TROSPIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
857560	trospium chloride 20 MG Oral Tablet	PSN	570c3ae7-8011-4944-8935-57d0a66102aa	12
857560	trospium chloride 20 MG Oral Tablet	SCD	570c3ae7-8011-4944-8935-57d0a66102aa	12
857560	trospium chloride 20 MG Oral Tablet	PSN	35ae4d64-4625-4fdd-a2d4-e20b87c56876	6
857560	trospium chloride 20 MG Oral Tablet	SCD	35ae4d64-4625-4fdd-a2d4-e20b87c56876	6
857560	trospium chloride 20 MG Oral Tablet	PSN	48d1b484-ee0a-4d66-9b45-4ba34e65ed13	4
857560	trospium chloride 20 MG Oral Tablet	SCD	48d1b484-ee0a-4d66-9b45-4ba34e65ed13	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
23155-530-02	23155053002	200 TABLET, FILM COATED in 1 BOTTLE (23155-530-02)	2016-08-30	0000-00-00	No	No	Current
23155-530-05	23155053005	500 TABLET, FILM COATED in 1 BOTTLE (23155-530-05)	2016-08-30	0000-00-00	No	No	Current
23155-530-06	23155053006	60 TABLET, FILM COATED in 1 BOTTLE (23155-530-06)	2016-08-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trospium Chloride	REMEDYREPACK INC.	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	4
Trospium Chloride	Major Pharmaceuticals	2025-07-21	HUMAN PRESCRIPTION DRUG LABEL	6
Trospium Chloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. \| Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.	2023-08-21	HUMAN PRESCRIPTION DRUG LABEL	12