Trospium Chloride

Product NDC: 72162-1106
11-digit product format: 721621106
Labeler code: 72162
Product ID: 72162-1106_849b6114-1cf2-4e15-a3aa-01abd680a6af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trospium Chloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA201291
Marketing category: ANDA
Marketing start: 2013-06-07
Substance: TROSPIUM CHLORIDE
Active strength: 60 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
A201291-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A201291-001	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A201291-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A201291-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201291-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201291-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201291-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201291-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201291-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201291-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A201291-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A201291-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A201291-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A201291-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A201291-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A201291-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A201291-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A201291-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A201291-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A201291-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A201291-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A201291-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A201291-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A201291-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A201291-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A201291-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A201291-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A201291-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A201291-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A201291-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A201291-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A201291-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A201291-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A201291-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A201291-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A201291-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A201291-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A201291-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A201291-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A201291-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A201291-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A201291-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Trospium Chloride
Brand name suffix: ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TROSPIUM CHLORIDE	60 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
857564	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
dfc1af0b-b0e7-43fd-8da0-65281963bc3e	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	Strength	SPL version
72162-1106-1	Trospium ChlorideER	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100		102
72162-1106-3	Trospium ChlorideER	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72162-1106-1	EA - Each	72162-1106	665ffa52-76a0-4a37-b1a3-7ed71f522710	1	2024-08-12
72162-1106-3	EA - Each	72162-1106	1364eece-3bd3-4526-8fc6-cbf6629b0873	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72162-1106	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]	101	Current NDC, 2 package rows	20240718_dfc1af0b-b0e7-43fd-8da0-65281963bc3e.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201291 application number: ANDA201291
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	dfc1af0b-b0e7-43fd-8da0-65281963bc3e	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201291 application number: ANDA201291 ndc (product): 72162-1106
Trospium Chloride ER	TROSPIUM CHLORIDE	Bryant Ranch Prepack	2f431dd1-e130-45e5-a796-1662f498585e	2023-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201291 application number: ANDA201291
Trospium Chloride ER	TROSPIUM CHLORIDE	Padagis US LLC	4574f905-a8c5-4732-b934-d1c7f9e708c9	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201291 application number: ANDA201291

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
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	dfc1af0b-b0e7-43fd-8da0-65281963bc3e	102
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	dfc1af0b-b0e7-43fd-8da0-65281963bc3e	102
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	dfc1af0b-b0e7-43fd-8da0-65281963bc3e	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
72162-1106-1	72162110601	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-1)	2023-09-13	No	No	Current
72162-1106-3	72162110603	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (72162-1106-3)	2023-09-13	No	No	Current