Trospium Chloride

Product NDC: 70518-4593
11-digit product format: 705184593
Labeler code: 70518
Product ID: 70518-4593_502530ff-ea3c-2d59-e063-6394a90a3345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trospium Chloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA204945
Marketing category: ANDA
Marketing start: 2026-03-23
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 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…`

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

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
48d1b484-ee0a-4d66-9b45-4ba34e65ed13	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
70518-4593-0	Trospium Chloride	30 in 1 BOX	TABLET, FILM COATED	30	4
70518-4593-1	Trospium Chloride	1 in 1 POUCH	TABLET, FILM COATED	1	4
70518-4593-2	Trospium Chloride	60 in 1 BOX	TABLET, FILM COATED	60	4
70518-4593-3	Trospium Chloride	100 in 1 BOX	TABLET, FILM COATED	100	4
70518-4593-4	Trospium Chloride	50 in 1 BOX	TABLET, FILM COATED	50	4

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.

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 ndc (product): 70518-4593
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

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	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	Units	Marketing start	Sample	Exclude flag	Status
70518-4593-0	70518459300	30 POUCH in 1 BOX (70518-4593-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)	30 pouch	2026-03-23	No	No	Current
70518-4593-1	70518459301	1 in 1 POUCH					Historical
70518-4593-2	70518459302	60 POUCH in 1 BOX (70518-4593-2) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)	60 pouch	2026-04-01	No	No	Current
70518-4593-3	70518459303	100 POUCH in 1 BOX (70518-4593-3) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)	100 pouch	2026-04-06	No	No	Current
70518-4593-4	70518459304	50 POUCH in 1 BOX (70518-4593-4) / 1 TABLET, FILM COATED in 1 POUCH (70518-4593-1)	50 pouch	2026-04-23	No	No	Current