TROSPIUM CHLORIDE

Product NDC: 71335-2961
11-digit product format: 713352961
Labeler code: 71335
Product ID: 71335-2961_3d8d7aaf-991d-4a8d-925f-41f361c79bf6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TROSPIUM CHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA091573
Marketing category: ANDA
Marketing start: 2010-11-17
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
A091573-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB		2010-11-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091573-001	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	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091573-001	TROSPIUM CHLORIDE	20MG	TABLET / ORAL	AB	2010-11-17	`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	A091573-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091573-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091573-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091573-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091573-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091573-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091573-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091573-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091573-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091573-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091573-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091573-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091573-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091573-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091573-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091573-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091573-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091573-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091573-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091573-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091573-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091573-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091573-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091573-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091573-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091573-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091573-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091573-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091573-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091573-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091573-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091573-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091573-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091573-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091573-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091573-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091573-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A091573-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A091573-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A091573-001	AB	1	`cb3db0bc1861…`

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
832d1e92-1024-495a-bb7f-590412aae699	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9151f483-8353-9cd4-427d-86fb1b5ba7ea	Product name	4	20211027
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
71335-2961-1	TROSPIUM CHLORIDE	60 in 1 BOTTLE	TABLET, FILM COATED	60		100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-2961-1	EA - Each	71335-2961	2f4f82a4-4ce0-4729-891f-5b8396808705	1	2025-12-16

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	095f54ba-4d43-4266-8942-eede6678ee3b	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	832d1e92-1024-495a-bb7f-590412aae699	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573 ndc (product): 71335-2961
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	PD-Rx Pharmaceuticals, Inc.	6303cf3c-175c-46ff-9b88-05f6ea7a2135	2025-10-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	871d70aa-4a7d-44dd-933c-969164b75942	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bryant Ranch Prepack	1065cfd9-3d32-466c-8dff-c81eae1a0533	2023-10-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Padagis US LLC	bb3284ee-3d13-41c7-8e4b-f9b2d44350da	2023-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091573 application number: ANDA091573

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	832d1e92-1024-495a-bb7f-590412aae699	100
857560	trospium chloride 20 MG Oral Tablet	SCD	832d1e92-1024-495a-bb7f-590412aae699	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-2961-1	71335296101	60 TABLET, FILM COATED in 1 BOTTLE (71335-2961-1)	2025-10-21	No	No	Current