TROSPIUM CHLORIDE

Product NDC: 68001-427
11-digit product format: 680010427
Labeler code: 68001
Product ID: 68001-427_ed27c30d-c83a-45af-9c47-807da858d696
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TROSPIUM CHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bluepoint Laboratories
Application: ANDA213185
Marketing category: ANDA
Marketing start: 2020-07-10
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 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
A213185-001	TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-04-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213185-001	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.

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	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213185-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-04-23	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A213185-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213185-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213185-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213185-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213185-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213185-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213185-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213185-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213185-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213185-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213185-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213185-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213185-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213185-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213185-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213185-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213185-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213185-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213185-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213185-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213185-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213185-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213185-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213185-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213185-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213185-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213185-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213185-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213185-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213185-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213185-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213185-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213185-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213185-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213185-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213185-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213185-001	AB	1	`a50c72e98297…`

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	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
ed27c30d-c83a-45af-9c47-807da858d696	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
68001-427-04	TROSPIUM CHLORIDE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-427-04	EA - Each	68001-427	f20f700a-4200-4ced-a26b-cae5a2371874	1	2020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-427	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	1	Current NDC, Legacy NDC, 1 package rows	20200710_ed27c30d-c83a-45af-9c47-807da858d696.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Granules Pharmaceuticals Inc.	5c088397-f407-4606-95a0-d9fe619888c3	2023-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213185 application number: ANDA213185
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Proficient Rx LP	5d0390ff-185d-41a7-9495-bb8006a05def	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213185 application number: ANDA213185
TROSPIUM CHLORIDE	TROSPIUM CHLORIDE	Bluepoint Laboratories	ed27c30d-c83a-45af-9c47-807da858d696	2020-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213185 application number: ANDA213185 ndc (product): 68001-427

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	ed27c30d-c83a-45af-9c47-807da858d696	1
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	ed27c30d-c83a-45af-9c47-807da858d696	1
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	ed27c30d-c83a-45af-9c47-807da858d696	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-427-04	68001042704	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68001-427-04)	2020-07-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TROSPIUM CHLORIDE	Bluepoint Laboratories \| Granules Pharmaceuticals Inc.	2020-07-08	HUMAN PRESCRIPTION DRUG LABEL	1