Fluvoxamine Maleate

Product NDC: 68084-837
11-digit product format: 680840837
Labeler code: 68084
Product ID: 68084-837_549c4325-376e-0a63-e063-6394a90a5076
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: American Health Packaging
Application: ANDA075902
Marketing category: ANDA
Marketing start: 2014-09-29
Substance: FLUVOXAMINE MALEATE
Active strength: 50 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

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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-837-21	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68084-837-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-837-21	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68084-837-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-837-21	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68084-837-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-837-21	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68084-837-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-837-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68084-837-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-837-21	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68084-837-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-837-21	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68084-837-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-837-21	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68084-837-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-837-21	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68084-837-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-837-21	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68084-837-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-837-21	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68084-837-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-837-21	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68084-837-25	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075902-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075902-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075902-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075902-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075902-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075902-003	AB	1	`caaa826d4ba7…`
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…`

Reported adverse events (FAERS/openFDA)#

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

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	50 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
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
0b107225-ed5a-4461-9184-f3f2bad1892f	Available on FDA.report

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-837-11	EA - Each	68084-837	2ff27af1-d4bc-4d29-b4ba-cbadc46e3b03	1	2014-11-05
68084-837-21	EA - Each	68084-837	02ee9ede-afd9-4de1-8373-f611eb6b8575	1	2014-11-05
68084-837-25	EA - Each	68084-837	37ce60c3-e709-4d2c-b1ef-9b42e8a9d30f	1	2016-03-04
68084-837-95	EA - Each	68084-837	641efb82-706a-4853-80e5-6ee372cb3873	1	2016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVOXAMINE MALEATE	ACTIVE INGREDIENT	5LGN83G74V	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
FLUVOXAMINE	ACTIVE MOIETY	O4L1XPO44W	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)	INACTIVE INGREDIENT	8136Y38GY5	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVOXAMINE MALEATE TABLET [AMERICAN HEALTH PACKAGING]	1

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	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 ndc (product): 68084-837
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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68084-837-21	68084083721	30 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-837-21) / 1 TABLET in 1 BLISTER PACK (68084-837-11)	30 blister pack	2014-09-29	No	No	Current