Fesoterodine Fumarate

Product NDC: 46708-176
Requested package NDC: 46708-176-10
11-digit product format: 467080176
Labeler code: 46708
Product ID: 46708-176_571147f2-e182-44b5-9d0b-ecfc3265cc2d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fesoterodine Fumarate
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Alembic Pharmaceuticals Limited
Application: ANDA204973
Marketing category: ANDA
Marketing start: 2023-01-06
Substance: FESOTERODINE FUMARATE
Active strength: 8 mg/1
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204973-001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-01-04
A204973-002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2023-01-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204973-001	AB
A204973-002	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 2 · 48 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	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204973-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204973-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2023-01-04	`a67488948f0b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 48 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	A204973-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204973-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204973-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204973-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204973-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204973-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204973-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204973-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204973-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204973-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204973-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204973-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204973-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204973-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204973-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204973-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204973-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204973-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204973-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204973-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204973-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204973-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204973-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204973-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204973-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204973-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204973-002	AB	1	`a67488948f0b…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fesoterodine Fumarate
Listing expiration: 2026-12-31

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
571147f2-e182-44b5-9d0b-ecfc3265cc2d	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
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	SPL version
46708-176-10	Fesoterodine Fumarate	100 in 1 CARTON	TABLET, EXTENDED RELEASE	100	1
46708-176-30	Fesoterodine Fumarate	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30	1
46708-176-90	Fesoterodine Fumarate	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90	1
46708-176-91	Fesoterodine Fumarate	1000 in 1 BOTTLE	TABLET, EXTENDED RELEASE	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
46708-176	FESOTERODINE FUMARATE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED]	1	Current NDC, 4 package rows	20230202_571147f2-e182-44b5-9d0b-ecfc3265cc2d.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	Alembic Pharmaceuticals Inc.	299db62d-9658-4796-b449-657fa859c5cd	2025-06-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204973 application number: ANDA204973
Fesoterodine Fumarate	FESOTERODINE FUMARATE	Alembic Pharmaceuticals Limited	571147f2-e182-44b5-9d0b-ecfc3265cc2d	2023-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204973 application number: ANDA204973 ndc (package): 46708-176-10 ndc (product): 46708-176 ndc11 (package): 46708017610

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	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1
810077	fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet	PSN	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1
810071	24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet	SCD	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1
810077	24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet	SCD	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1
810071	fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet	SY	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1
810077	fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet	SY	571147f2-e182-44b5-9d0b-ecfc3265cc2d	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
46708-176-10	46708017610	100 TABLET, EXTENDED RELEASE in 1 CARTON (46708-176-10)	2023-01-06	No	No	Current