TROSPIUM CHLORIDE

Product NDC: 70010-027
11-digit product format: 700100027
Labeler code: 70010
Product ID: 70010-027_0194b277-edb7-e7f8-e063-6394a90a6c25
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: TROSPIUM CHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA213185
Marketing category: ANDA
Marketing start: 2020-08-19
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…`

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 · 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 ndc (product): 70010-027
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

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
5c088397-f407-4606-95a0-d9fe619888c3	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
70010-027-03	TROSPIUM CHLORIDE	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		7
70010-027-05	TROSPIUM CHLORIDE	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-027	TROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	7	Current NDC, Legacy NDC, 2 package rows	20230730_5c088397-f407-4606-95a0-d9fe619888c3.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
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	5c088397-f407-4606-95a0-d9fe619888c3	7
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	5c088397-f407-4606-95a0-d9fe619888c3	7
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	5c088397-f407-4606-95a0-d9fe619888c3	7
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	5d0390ff-185d-41a7-9495-bb8006a05def	2
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	5d0390ff-185d-41a7-9495-bb8006a05def	2
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	5d0390ff-185d-41a7-9495-bb8006a05def	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70010-027-03	70010002703	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-027-03)	2020-08-19	0000-00-00	No	No	Current
70010-027-05	70010002705	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-027-05)	2020-08-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TROSPIUM CHLORIDE	Granules Pharmaceuticals Inc.	2023-07-28	HUMAN PRESCRIPTION DRUG LABEL	7
TROSPIUM CHLORIDE	Proficient Rx LP	2022-04-01	HUMAN PRESCRIPTION DRUG LABEL	2