Trospium Chloride

Product NDC: 0574-0118
11-digit product format: 005740118
Labeler code: 0574
Product ID: 0574-0118_d3a1d06a-74e4-40db-890f-046078da9ad2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Trospium Chloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Padagis US LLC
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 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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201291-001	TROSPIUM CHLORIDE	60MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-05-24	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A201291-001	AB	1	`cb3db0bc1861…`

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
4574f905-a8c5-4732-b934-d1c7f9e708c9	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
0574-0118-30	Trospium ChlorideER	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-0118-30	EA - Each	0574-0118	1db7152b-3735-4fc9-8eed-ca1461288fdc	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Trospium Chloride	ACTIVE INGREDIENT	1E6682427E	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
Trospium	ACTIVE MOIETY	T4Y8ORK057	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
gelatin	INACTIVE INGREDIENT	2G86QN327L	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
magnesium stearate	INACTIVE INGREDIENT	70097M6I30	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
methacrylic acid - ethyl acrylate copolymer (1:1) type a	INACTIVE INGREDIENT	NX76LV5T8J	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
polyethylene glycol 400	INACTIVE INGREDIENT	B697894SGQ	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
potassium hydroxide	INACTIVE INGREDIENT	WZH3C48M4T	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
povidones	INACTIVE INGREDIENT	FZ989GH94E	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
shellac	INACTIVE INGREDIENT	46N107B71O	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
talc	INACTIVE INGREDIENT	7SEV7J4R1U	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADDOCK LABORATORIES, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0574-0118	TROSPIUM CHLORIDE ER (TROSPIUM CHLORIDE) CAPSULE, EXTENDED RELEASE [PADAGIS US LLC]	6	Current NDC, Legacy NDC, 1 package rows	20240614_4574f905-a8c5-4732-b934-d1c7f9e708c9.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
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 ndc (product): 0574-0118

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	2f431dd1-e130-45e5-a796-1662f498585e	105
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	2f431dd1-e130-45e5-a796-1662f498585e	105
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	2f431dd1-e130-45e5-a796-1662f498585e	105
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
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1	100
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1	100
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	c0a8f7d7-bc7e-4bf7-92c2-fcb2ab67f0e1	100
857564	trospium chloride 60 MG 24HR Extended Release Oral Capsule	PSN	4574f905-a8c5-4732-b934-d1c7f9e708c9	6
857564	24 HR trospium chloride 60 MG Extended Release Oral Capsule	SCD	4574f905-a8c5-4732-b934-d1c7f9e708c9	6
857564	trospium chloride 60 MG 24 HR Extended Release Oral Capsule	SY	4574f905-a8c5-4732-b934-d1c7f9e708c9	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-0118-30	00574011830	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0574-0118-30)	2013-06-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Trospium Chloride ER	Bryant Ranch Prepack	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
Trospium Chloride ER	Bryant Ranch Prepack	2024-07-16	HUMAN PRESCRIPTION DRUG LABEL	102
Trospium Chloride ER	Bryant Ranch Prepack	2023-11-06	HUMAN PRESCRIPTION DRUG LABEL	105
Trospium Chloride ER	Padagis US LLC	2022-11-30	HUMAN PRESCRIPTION DRUG LABEL	6