Fluvoxamine Maleate

Product NDC: 73190-067
11-digit product format: 731900067
Labeler code: 73190
Product ID: 73190-067_45279386-bef9-3bab-e063-6294a90aee92
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: AvKARE
Application: ANDA091482
Marketing category: ANDA
Marketing start: 2025-12-04
Substance: FLUVOXAMINE MALEATE
Active strength: 150 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091482-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23
A091482-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A091482-001	AB
A091482-002	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 3 · 82 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	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091482-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-04-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091482-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	RS	2013-11-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A091482-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091482-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091482-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091482-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091482-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091482-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091482-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091482-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091482-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091482-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091482-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091482-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091482-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091482-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091482-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091482-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091482-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091482-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091482-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091482-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091482-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091482-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091482-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091482-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091482-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091482-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Fluvoxamine Maleate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FLUVOXAMINE MALEATE	150 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
903873	Internal RxNorm lookup
903879	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
4527a684-51c0-1858-e063-6394a90a2631	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
73190-067-30	Fluvoxamine Maleate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
73190-067-30	EA - Each	73190-067	ee1e9535-ccbc-43dc-9381-bcc1a1903613	1	2026-01-08

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	AvKARE	4527a684-51c0-1858-e063-6394a90a2631	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091482 application number: ANDA091482 ndc (product): 73190-067
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Actavis Pharma, Inc.	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091482 application number: ANDA091482

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
903873	fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule	PSN	4527a684-51c0-1858-e063-6394a90a2631	1
903879	fluvoxaMINE maleate 150 MG 24HR Extended Release Oral Capsule	PSN	4527a684-51c0-1858-e063-6394a90a2631	1
903873	24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule	SCD	4527a684-51c0-1858-e063-6394a90a2631	1
903879	24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule	SCD	4527a684-51c0-1858-e063-6394a90a2631	1
903873	fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule	SY	4527a684-51c0-1858-e063-6394a90a2631	1
903879	fluvoxamine maleate 150 MG 24 HR Extended Release Oral Capsule	SY	4527a684-51c0-1858-e063-6394a90a2631	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
73190-067-30	73190006730	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-067-30)	2025-12-04	No	No	Current