Fluvoxamine Maleate

Product NDC: 0615-7569
11-digit product format: 006157569
Labeler code: 0615
Product ID: 0615-7569_37c5c6bd-6df6-4f8c-b7f1-c19bb8d8243e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NCS HealthCare of KY, Inc dba Vangard Labs
Application: ANDA075893
Marketing category: ANDA
Marketing start: 2010-03-12
Marketing end: 0000-00-00
Substance: FLUVOXAMINE MALEATE
Active strength: 100 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0615-7569		D	Discontinued by firm		2026-08-03
excluded package	package	0615-7569	0615-7569-39	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0615-7569-39	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0615-7569-39	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0615-7569-39	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0615-7569-39	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0615-7569-39	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0615-7569-39	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0615-7569-39	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0615-7569-39	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0615-7569-39	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0615-7569-39	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0615-7569-39	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0615-7569-39	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0615-7569-39	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0615-7569-39	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0615-7569-39	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	Approval date
A075893-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10
A075893-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10
A075893-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10

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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075893-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2002-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075893-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2002-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075893-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2002-09-10	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A075893-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075893-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A075893-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A075893-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075893-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A075893-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075893-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075893-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A075893-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075893-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075893-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A075893-003	AB	1	`ea99ee380514…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0615-7569-39	2021-05-14	C162847	48780-1	9d75b9d1-0b4f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use fluvoxamine maleate tablets USP safely and effectively. See full prescribing information for fluvoxamine maleate tablets USP. Fluvoxamine maleate tablets USP, for oral use Initial U.S. Approval: 1994
0615-7569-39	2020-01-31	C162847	48780-1	9d75b9d1-0b4f-f424-e053-dadaa90a57ce	These highlights do not include all the information needed to use fluvoxamine maleate tablets USP safely and effectively. See full prescribing information for fluvoxamine maleate tablets USP. Fluvoxamine maleate tablets USP, for oral use Initial U.S. Approval: 1994

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVOXAMINE MALEATE	ACTIVE INGREDIENT	5LGN83G74V	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FLUVOXAMINE	ACTIVE MOIETY	O4L1XPO44W	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVOXAMINE MALEATE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine Maleate	NCS HealthCare of KY, Inc dba Vangard Labs	2013-03-04	HUMAN PRESCRIPTION DRUG LABEL	4