Fluvoxamine maleate

Product NDC: 69452-289
Requested package NDC: 69452-289-20
11-digit product format: 694520289
Labeler code: 69452
Product ID: 69452-289_2fa05c01-e84f-99b2-e063-6394a90af57f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine maleate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA217917
Marketing category: ANDA
Marketing start: 2024-05-23
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…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 ndc (package): 69452-289-20 ndc (product): 69452-289 ndc11 (package): 69452028920
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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903884	Internal RxNorm lookup
903887	Internal RxNorm lookup
903891	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
191912e6-b3c8-be1a-e063-6394a90a8dd4	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	Strength	SPL version
69452-289-20	Fluvoxamine maleate	100 in 1 BOTTLE	TABLET, FILM COATED	100		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-289-20	EA - Each	69452-289	d7a005ce-3d0d-4caf-951c-3d52df2d9263	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-289	FLUVOXAMINE MALEATE TABLET, FILM COATED FLUVOXAMINE MALEATE TABLET [BIONPHARMA INC.]	2	Current NDC, 1 package rows	20250308_191912e6-b3c8-be1a-e063-6394a90a8dd4.zip

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	191912e6-b3c8-be1a-e063-6394a90a8dd4	2
903887	fluvoxaMINE maleate 25 MG Oral Tablet	PSN	191912e6-b3c8-be1a-e063-6394a90a8dd4	2
903891	fluvoxaMINE maleate 50 MG Oral Tablet	PSN	191912e6-b3c8-be1a-e063-6394a90a8dd4	2
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	191912e6-b3c8-be1a-e063-6394a90a8dd4	2
903887	fluvoxamine maleate 25 MG Oral Tablet	SCD	191912e6-b3c8-be1a-e063-6394a90a8dd4	2
903891	fluvoxamine maleate 50 MG Oral Tablet	SCD	191912e6-b3c8-be1a-e063-6394a90a8dd4	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
69452-289-20	69452028920	100 TABLET, FILM COATED in 1 BOTTLE (69452-289-20)	2024-05-23	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine maleate	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	2