fluvoxamine maleate

Product NDC: 63629-8018
11-digit product format: 636298018
Labeler code: 63629
Product ID: 63629-8018_9156a6f7-4692-4d97-9118-dad2a688e6f2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine maleate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021519
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-08-09
Marketing end: 0000-00-00
Substance: FLUVOXAMINE MALEATE
Active strength: 25 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	63629-8018		D	Discontinued by firm		2026-08-03
excluded package	package	63629-8018	63629-8018-1	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 · 4 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
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	63629-8018-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	63629-8018-1	`1332a3947898…`	`d4bfe170f9cd…`

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	RLD / RS	Approval date
N021519-001	LUVOX	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	RLD	2007-12-20
N021519-002	LUVOX	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	RLD	2007-12-20
N021519-003	LUVOX	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	RLD	2007-12-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021519-001	AB
N021519-002	AB
N021519-003	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-002	LUVOX	50MG	TABLET / ORAL	AB	RLD	2007-12-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-003	LUVOX	100MG	TABLET / ORAL	AB	RLD	2007-12-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021519-001	LUVOX	25MG	TABLET / ORAL	AB	RLD	2007-12-20	`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	N021519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021519-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021519-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021519-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021519-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021519-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021519-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021519-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021519-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021519-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021519-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021519-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021519-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021519-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021519-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021519-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021519-001	AB	1	`8072bd15b7f6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63629-8018-1	2024-05-14	C162847	48780-1	1030e365-6faf-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994
63629-8018-1	2024-01-30	C162847	48780-1	1030e365-6faf-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE TABLETS safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE TABLETS. FLUVOXAMINE MALEATE tablets, for oral use Initial U.S. Approval: 1994

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-8018	FLUVOXAMINE MALEATE TABLET, COATED [BRYANT RANCH PREPACK]	3	Legacy NDC	20240516_9156a6f7-4692-4d97-9118-dad2a688e6f2.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fluvoxamine maleate	FLUVOXAMINE MALEATE	REMEDYREPACK INC.	5198b1c8-8dd6-4b8f-bd85-294ac468af53	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021519 application number: NDA021519
fluvoxamine maleate	FLUVOXAMINE MALEATE	Preferred Pharmaceuticals, Inc.	b5b2128d-2363-4966-971f-83219755ecd7	2026-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021519 application number: NDA021519
fluvoxamine maleate	FLUVOXAMINE MALEATE	REMEDYREPACK INC.	88b5207a-d87b-4541-ac6b-aa1c51715fcf	2026-01-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021519 application number: NDA021519
fluvoxamine maleate	FLUVOXAMINE MALEATE	ANI Pharmaceuticals, Inc.	7ecd83ec-88f5-4f85-9cc2-9068375d8820	2025-08-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021519 application number: NDA021519
fluvoxamine maleate	FLUVOXAMINE MALEATE	A-S Medication Solutions	ddc9e7e8-f041-43bb-970b-cd4b30367637	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021519 application number: NDA021519

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	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-8018-1	63629801801	30 TABLET, COATED in 1 BOTTLE (63629-8018-1)	2019-06-14	0000-00-00	No	No	Current