Fluvoxamine Maleate

Product NDC: 68788-8175
11-digit product format: 687888175
Labeler code: 68788
Product ID: 68788-8175_e8faf176-d195-4e5f-a7dc-a17a05985ec6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA075902
Marketing category: ANDA
Marketing start: 2022-04-27
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: 2027-12-31
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
A075902-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07
A075902-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07
A075902-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075902-001	AB
A075902-002	AB
A075902-003	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 4 · 123 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	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A075902-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075902-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075902-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075902-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075902-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075902-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075902-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075902-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075902-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075902-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075902-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075902-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075902-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075902-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075902-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075902-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075902-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075902-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluvoxamine Maleate
Listing expiration: 2027-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903884	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
a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68788-8175-3	Fluvoxamine Maleate	30 in 1 BOTTLE	TABLET	30	5
68788-8175-6	Fluvoxamine Maleate	60 in 1 BOTTLE	TABLET	60	5
68788-8175-9	Fluvoxamine Maleate	90 in 1 BOTTLE	TABLET	90	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68788-8175-3	EA - Each	68788-8175	47f37f91-2ea9-43dd-9e1f-15d053547974	1	2022-07-06
68788-8175-6	EA - Each	68788-8175	413dd5c5-7a7e-4b4a-8131-1ca59ef9fd07	1	2022-07-06
68788-8175-9	EA - Each	68788-8175	93445f04-f534-47e5-b7ce-cd801808b890	1	2022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-8175	FLUVOXAMINE MALEATE TABLET [PREFERRED PHARMACEUTICALS INC.]	3	Current NDC, Legacy NDC, 3 package rows	20240504_a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	American Health Packaging	0b107225-ed5a-4461-9184-f3f2bad1892f	2026-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals Inc.	a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902 ndc (product): 68788-8175
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	4239fc32-e5cb-4393-b90c-742db42b5d07	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Bryant Ranch Prepack	47daea9e-545d-4a67-b2b2-d12c3c98734b	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	PD-Rx Pharmaceuticals, Inc.	9972efbb-46cd-45b7-b71c-35032311b70c	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Apotex Corp	6eeb14df-6fcf-a737-5359-5744eb4accea	2025-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075902 application number: ANDA075902

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	a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3	5
903884	fluvoxamine maleate 100 MG Oral Tablet	SCD	a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-8175-3	68788817503	30 TABLET in 1 BOTTLE (68788-8175-3)	30 tablet	2022-04-27	0000-00-00	No	No	Current
68788-8175-6	68788817506	60 TABLET in 1 BOTTLE (68788-8175-6)	60 tablet	2022-04-27	0000-00-00	No	No	Current
68788-8175-9	68788817509	90 TABLET in 1 BOTTLE (68788-8175-9)	90 tablet	2022-04-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine Maleate	Preferred Pharmaceuticals Inc. \| Preferred Pharmaceuticals Inc..	2026-04-22	HUMAN PRESCRIPTION DRUG LABEL	5