Fluvoxamine maleate

Product NDC: 69452-455
11-digit product format: 694520455
Labeler code: 69452
Product ID: 69452-455_2df4f998-43b1-dca5-e063-6394a90aae95
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA217917
Marketing category: ANDA
Marketing start: 2025-02-07
Substance: FLUVOXAMINE MALEATE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217917-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22
A217917-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22
A217917-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217917-001	AB
A217917-002	AB
A217917-003	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 · 51 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	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2024-01-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2024-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217917-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2024-01-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 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	A217917-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217917-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217917-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217917-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217917-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217917-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217917-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217917-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217917-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217917-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217917-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217917-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217917-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217917-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217917-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217917-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217917-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluvoxamine maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUVOXAMINE MALEATE	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5LGN83G74V	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903884	Internal RxNorm lookup
903887	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
2df4f9cf-5803-d8ea-e063-6394a90ad855	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234d	Product name	3	20250515
0b12fd59-0eda-41d5-8618-6195bcd36a86	Product name	1	20250114
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69452-455-20	Fluvoxamine maleate	100 in 1 BOTTLE	TABLET	100	1
69452-455-30	Fluvoxamine maleate	500 in 1 BOTTLE	TABLET	500	1
69452-455-32	Fluvoxamine maleate	1000 in 1 BOTTLE	TABLET	1000	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-455-20	EA - Each	69452-455	3788a4ea-1ab9-425c-9f5e-3d94818e90b6	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-455	FLUVOXAMINE MALEATE TABLET [BIONPHARMA INC.]	1	Current NDC, 3 package rows	20250214_2df4f9cf-5803-d8ea-e063-6394a90ad855.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	c3d59ca9-dd42-4b1c-bd2d-23eb507598b8	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	A-S Medication Solutions	35b377d9-5b7a-4d8e-b6c1-4291d02f5dae	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals Inc.	642b7b5e-9f1c-479b-b9b3-bf06774f7b60	2025-09-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	191912e6-b3c8-be1a-e063-6394a90a8dd4	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917
Fluvoxamine maleate	FLUVOXAMINE MALEATE	Bionpharma Inc.	2df4f9cf-5803-d8ea-e063-6394a90ad855	2025-02-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217917 application number: ANDA217917 ndc (product): 69452-455

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5LGN83G74V	FLUVOXAMINE MALEATE	61718-82-9	FLUVOXAMINE MALEATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
903884	fluvoxaMINE maleate 100 MG Oral Tablet	PSN	2df4f9cf-5803-d8ea-e063-6394a90ad855	1
903884	fluvoxaMINE maleate 100 MG Oral Tablet	PSN	35b377d9-5b7a-4d8e-b6c1-4291d02f5dae	1
903884	fluvoxaMINE maleate 100 MG Oral Tablet	PSN	642b7b5e-9f1c-479b-b9b3-bf06774f7b60	1
903884	fluvoxaMINE maleate 100 MG Oral Tablet	PSN	c3d59ca9-dd42-4b1c-bd2d-23eb507598b8	1
903887	fluvoxaMINE maleate 25 MG Oral Tablet	PSN	2df4f9cf-5803-d8ea-e063-6394a90ad855	1
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	2df4f9cf-5803-d8ea-e063-6394a90ad855	1
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	35b377d9-5b7a-4d8e-b6c1-4291d02f5dae	1
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	642b7b5e-9f1c-479b-b9b3-bf06774f7b60	1
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	c3d59ca9-dd42-4b1c-bd2d-23eb507598b8	1
903887	fluvoxamine maleate 25 MG Oral Tablet	SCD	2df4f9cf-5803-d8ea-e063-6394a90ad855	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
69452-455-20	69452045520	100 TABLET in 1 BOTTLE (69452-455-20)	100 tablet	2025-02-07	No	No	Current
69452-455-30	69452045530	500 TABLET in 1 BOTTLE (69452-455-30)	500 tablet	2025-02-07	No	No	Current
69452-455-32	69452045532	1000 TABLET in 1 BOTTLE (69452-455-32)	1000 tablet	2025-02-07	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine maleate	Bryant Ranch Prepack	2026-02-04	HUMAN PRESCRIPTION DRUG LABEL	1
Fluvoxamine maleate	A-S Medication Solutions	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	1
Fluvoxamine maleate	Preferred Pharmaceuticals Inc.	2025-09-04	HUMAN PRESCRIPTION DRUG LABEL	1
Fluvoxamine maleate	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2025-02-12	HUMAN PRESCRIPTION DRUG LABEL	1