FESOTERODINE FUMARATE EXTENDED-RELEASE TABLETS

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-11-30
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 21:18:23

Label at a glance#

Productfesoterodine fumarate

Active ingredientFESOTERODINE FUMARATE

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1168-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 4 mg

Rx only

90 tablets

NDC 70771-1169-9 in bottle of 90 tablets

Fesoterodine Fumarate Extended-release Tablets, 8 mg

Rx only

90 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
810071	fesoterodine fumarate 4 MG 24HR Extended Release Oral Tablet	PSN	5
810077	fesoterodine fumarate 8 MG 24HR Extended Release Oral Tablet	PSN	5
810071	24 HR fesoterodine fumarate 4 MG Extended Release Oral Tablet	SCD	5
810077	24 HR fesoterodine fumarate 8 MG Extended Release Oral Tablet	SCD	5
810071	fesoterodine fumarate 4 MG 24 HR Extended Release Oral Tablet	SY	5
810077	fesoterodine fumarate 8 MG 24 HR Extended Release Oral Tablet	SY	5

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	SPL version
70771-1168-2	fesoterodine fumarate	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	5
70771-1168-3	fesoterodine fumarate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	5
70771-1168-4	fesoterodine fumarate	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	5
70771-1168-9	fesoterodine fumarate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	5
70771-1169-2	fesoterodine fumarate	10 in 1 BLISTER PACK	TABLET, FILM COATED, EXTENDED RE	10	5
70771-1169-3	fesoterodine fumarate	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30	5
70771-1169-4	fesoterodine fumarate	10 in 1 CARTON	TABLET, FILM COATED, EXTENDED RE	10	5
70771-1169-9	fesoterodine fumarate	90 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	90	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1168	FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20241201_26e8cc63-1e1d-4a77-8f53-4c38bcf0d443.zip
70771-1169	FESOTERODINE FUMARATE TABLET, FILM COATED, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]	5	Current NDC, Legacy NDC, 4 package rows	20241201_26e8cc63-1e1d-4a77-8f53-4c38bcf0d443.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

fesoterodine fumarate
FESOTERODINE
STARCH, CORN
HYPROMELLOSES
LACTOSE MONOHYDRATE
LECITHIN, SOYBEAN
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TALC
TITANIUM DIOXIDE
XANTHAN GUM
FERRIC OXIDE YELLOW
POLYVINYL ALCOHOL, UNSPECIFIED

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1168	70771-1168-3, 70771-1168-9, 70771-1168-2, 70771-1168-4
70771-1169	70771-1169-3, 70771-1169-9, 70771-1169-2, 70771-1169-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FESOTERODINE FUMARATE	EOS72165S7	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
FERRIC OXIDE YELLOW	EX438O2MRT	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT
FESOTERODINE FUMARATE	EOS72165S7	ACTIB
STARCH, CORN	O8232NY3SJ	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
CELLULOSE, MICROCRYSTALLINE	OP1R32D61U	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
XANTHAN GUM	TTV12P4NEE	IACT
POLYVINYL ALCOHOL, UNSPECIFIED	532B59J990	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A204946-001	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-10-03
A204946-002	FESOTERODINE FUMARATE	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204946-001	AB
A204946-002	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 · 88 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
2026-10-15 13:18:30	2026-09	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204946-001	FESOTERODINE FUMARATE	4MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204946-002	FESOTERODINE FUMARATE	8MG	TABLET, EXTENDED RELEASE / ORAL	AB	2017-10-03	`4b0b4de00fa7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A204946-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A204946-002	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A204946-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204946-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204946-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204946-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204946-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204946-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204946-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204946-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204946-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204946-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204946-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204946-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204946-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204946-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204946-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204946-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204946-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204946-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204946-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204946-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204946-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204946-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204946-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204946-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204946-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204946-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204946-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204946-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204946-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204946-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204946-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204946-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204946-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204946-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204946-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204946-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204946-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204946-002	AB	1	`4b0b4de00fa7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fesoterodine fumarate	FESOTERODINE FUMARATE	Zydus Lifesciences Limited	26e8cc63-1e1d-4a77-8f53-4c38bcf0d443	2024-11-30		Exact identifier ndc (package): 70771-1168-4 ndc (package): 70771-1169-4 ndc (package): 70771-1169-3 ndc (package): 70771-1168-2 ndc (package): 70771-1169-9 ndc (package): 70771-1168-9 ndc (package): 70771-1168-3 ndc (package): 70771-1169-2 ndc (product): 70771-1169 ndc (product): 70771-1168 ndc11 (package): 70771116909 ndc11 (package): 70771116802 ndc11 (package): 70771116902 ndc11 (package): 70771116904 ndc11 (package): 70771116809 ndc11 (package): 70771116903 ndc11 (package): 70771116803 ndc11 (package): 70771116804 spl id: 5b9a792a-f173-43f9-917a-af99185196e1 spl set id: 26e8cc63-1e1d-4a77-8f53-4c38bcf0d443

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.