Fesoterodine fumarate

Product NDC: 43598-248
11-digit product format: 435980248
Labeler code: 43598
Product ID: 43598-248_fb4f7798-3094-ebec-3314-24b3aa54f927
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fesoterodine fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Dr.Reddy's Laboratories Inc.,
Application: ANDA204975
Marketing category: ANDA
Marketing start: 2022-06-10
Substance: FESOTERODINE FUMARATE
Active strength: 8 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204975-001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-13
A204975-002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-08-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A204975-001	AB
A204975-002	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 3 · 82 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	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204975-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204975-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL		2019-08-13	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 64 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	A204975-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204975-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204975-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204975-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204975-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204975-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204975-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204975-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204975-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204975-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204975-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204975-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204975-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204975-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204975-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204975-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204975-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204975-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204975-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204975-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204975-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204975-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204975-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204975-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204975-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204975-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204975-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204975-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204975-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204975-002	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A204975-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204975-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A204975-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204975-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204975-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204975-002	AB	1	`b00525d2431f…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204975-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204975-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204975-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204975-002	AB	1	`1c564ffb4f44…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fesoterodine fumarate
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FESOTERODINE FUMARATE	8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
EOS72165S7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
810071	Internal RxNorm lookup
810077	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
5c5d2a97-9029-744f-c410-a4bbbe9761a8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
929b9598-46e7-5b66-7a86-5544524fb173	Product name	6	20240208

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-248-30	Fesoterodine fumarate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		10
43598-248-90	Fesoterodine fumarate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-248-30	EA - Each	43598-248	0d277448-f526-44d6-a901-342412a79157	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-248	FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [DR.REDDY'S LABORATORIES INC.,]	9	Current NDC, Legacy NDC, 2 package rows	20250514_5c5d2a97-9029-744f-c410-a4bbbe9761a8.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fesoterodine fumarate	FESOTERODINE FUMARATE	Golden State Medical Supply, Inc.	e5e6e146-d39a-471c-e053-2995a90a7538	2025-12-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204975 application number: ANDA204975
Fesoterodine fumarate	FESOTERODINE FUMARATE	Dr.Reddy's Laboratories Inc.,	5c5d2a97-9029-744f-c410-a4bbbe9761a8	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204975 application number: ANDA204975 ndc (product): 43598-248

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
EOS72165S7	FESOTERODINE FUMARATE	286930-03-8	FESOTERODINE FUMARATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
810071	fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet	PSN	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810077	fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet	PSN	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810071	24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet	SCD	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810077	24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet	SCD	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810071	fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet	SY	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810077	fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet	SY	5c5d2a97-9029-744f-c410-a4bbbe9761a8	10
810071	fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet	PSN	e5e6e146-d39a-471c-e053-2995a90a7538	3
810077	fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet	PSN	e5e6e146-d39a-471c-e053-2995a90a7538	3
810071	24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet	SCD	e5e6e146-d39a-471c-e053-2995a90a7538	3
810077	24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet	SCD	e5e6e146-d39a-471c-e053-2995a90a7538	3
810071	fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet	SY	e5e6e146-d39a-471c-e053-2995a90a7538	3
810077	fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet	SY	e5e6e146-d39a-471c-e053-2995a90a7538	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-248-30	43598024830	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-30)	2022-06-10	0000-00-00	No	No	Current
43598-248-90	43598024890	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-90)	2022-06-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fesoterodine fumarate	Golden State Medical Supply, Inc.	2025-12-18	HUMAN PRESCRIPTION DRUG LABEL	3
Fesoterodine fumarate	Dr.Reddy's Laboratories Inc., \| Dr. Reddy's Laboratories Limited FTO-3	2025-09-01	HUMAN PRESCRIPTION DRUG LABEL	10