fluvoxamine maleate

Product NDC: 68071-2337
Requested package NDC: 68071-2337-1
11-digit product format: 680712337
Labeler code: 68071
Product ID: 68071-2337_ba0e263a-1ed7-9c0a-e053-2995a90a9fed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine maleate
Dosage form: TABLET, COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: NDA021519
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-08-09
Marketing end: 0000-00-00
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: 2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68071-2337	68071-2337-1	I	Inactivated by FDA		2026-08-07

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2337-1	2023-01-30	C162847	48780-1	f386c649-b155-0266-e053-dadaa90a7c1a	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2337-1	fluvoxamine maleate	100 in 1 BOTTLE	TABLET, COATED	100		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2337	FLUVOXAMINE MALEATE TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20210130_ba0de917-bfb8-d350-e053-2a95a90ac90f.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
903891	fluvoxaMINE maleate 50 MG Oral Tablet	PSN	ba0de917-bfb8-d350-e053-2a95a90ac90f	1
903891	fluvoxamine maleate 50 MG Oral Tablet	SCD	ba0de917-bfb8-d350-e053-2a95a90ac90f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2337-1	68071233701	100 TABLET, COATED in 1 BOTTLE (68071-2337-1)	2021-01-29	0000-00-00	No	No	Current