FLUVOXAMINE MALEATE

Product NDC: 57664-362
11-digit product format: 576640362
Labeler code: 57664
Product ID: 57664-362_4dec9bd6-6451-422d-aee2-dfbc55e0ca6e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: fluvoxamine maleate
Dosage form: TABLET
Route: ORAL
Labeler: Caraco Pharmaceutical Laboratories, Ltd.
Application: ANDA075900
Marketing category: ANDA
Marketing start: 2006-02-23
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: 2018-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	57664-362		D	Discontinued by firm	2026-08-03
excluded package	package	57664-362	57664-362-13	D	Discontinued by firm	2026-08-03
excluded package	package	57664-362	57664-362-18	D	Discontinued by firm	2026-08-03
excluded package	package	57664-362	57664-362-88	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 · 52 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	57664-362-88	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-362-18	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-362-18	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-362-18	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-362-18	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-362-18	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-362-18	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-362-18	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-362-18	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-362-18	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-362-18	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-362-18	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	57664-362-13	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	57664-362-88	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-362-18	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	57664-362-13	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	57664-362-88	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	57664-362-13	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	57664-362-18	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
A075900-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23
A075900-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23
A075900-003	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23

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	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075900-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	2006-02-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075900-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	2006-02-23	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57664-362-13	EA - Each	57664-362	eb259a96-793d-4e83-b365-2e380ac4bc30	1	2012-07-24
57664-362-88	EA - Each	57664-362	b1959e2b-1e38-41af-aac2-d140f3a8b0cb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVOXAMINE MALEATE	ACTIVE INGREDIENT	5LGN83G74V	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
FLUVOXAMINE	ACTIVE MOIETY	O4L1XPO44W	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
COLLOIDAL SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVOXAMINE MALEATE TABLET FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.]	4

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Chartwell RX, LLC	b8320308-084f-43fb-9b1d-5620a0efaf46	2025-01-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075900 application number: ANDA075900

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	Caraco Pharmaceutical Laboratories, Ltd.	2011-10-20	HUMAN PRESCRIPTION DRUG LABEL	4