Fluvoxamine Maleate

Product NDC: 71335-1974
11-digit product format: 713351974
Labeler code: 71335
Product ID: 71335-1974_edc23496-df64-4284-9f04-f2b35bf19c00
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA075902
Marketing category: ANDA
Marketing start: 2001-07-10
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 · 6 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	71335-1974-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	71335-1974-1	`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	71335-1974-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	71335-1974-1	`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	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 · 123 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
2026-02-19 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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-002	FLUVOXAMINE MALEATE	50MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-003	FLUVOXAMINE MALEATE	100MG	TABLET / ORAL	AB	2001-05-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075902-001	FLUVOXAMINE MALEATE	25MG	TABLET / ORAL	AB	2001-05-07	`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	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…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075902-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075902-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075902-001	AB	1	`8072bd15b7f6…`

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
47daea9e-545d-4a67-b2b2-d12c3c98734b	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
71335-1974-1	2024-05-17	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
71335-1974-2	2024-05-17	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
71335-1974-1	2024-01-30	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
71335-1974-2	2024-01-30	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
71335-1974-1	Fluvoxamine Maleate	60 in 1 BOTTLE	TABLET	60		103
71335-1974-2	Fluvoxamine Maleate	30 in 1 BOTTLE	TABLET	30		103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1974	FLUVOXAMINE MALEATE TABLET [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 2 package rows	20240518_47daea9e-545d-4a67-b2b2-d12c3c98734b.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 · 6 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
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 ndc (product): 71335-1974
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
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Apotex Corp	6eeb14df-6fcf-a737-5359-5744eb4accea	2025-09-18	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
903891	fluvoxaMINE maleate 50 MG Oral Tablet	PSN	47daea9e-545d-4a67-b2b2-d12c3c98734b	103
903891	fluvoxamine maleate 50 MG Oral Tablet	SCD	47daea9e-545d-4a67-b2b2-d12c3c98734b	103

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1974-1	71335197401	60 TABLET in 1 BOTTLE (71335-1974-1)	60 tablet	2022-02-14	0000-00-00	No	No	Current
71335-1974-2	71335197402	30 TABLET in 1 BOTTLE (71335-1974-2)	30 tablet	2021-10-14	0000-00-00	No	No	Current