Fluvoxamine Maleate

Product NDC: 0228-2849
Requested package NDC: 0228-2849-00
11-digit product format: 002282849
Labeler code: 0228
Product ID: 0228-2849_b051dd36-d5c1-48f0-93d9-1d6fae21b16f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Actavis Pharma, Inc.
Application: ANDA091482
Marketing category: ANDA
Marketing start: 2014-08-05
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

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
unfinished package	package	0228-2849	0228-2849-00	UNFINISHED	Active or certified unfinished drug listing		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 · 6 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 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`

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
8bbd7e39-b9ab-4716-9522-aa8c4b92210e	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
0228-2849-03	Fluvoxamine Maleate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0228-2849-03	EA - Each	0228-2849	3dc86f69-59b0-441d-ba35-e4a05da75ba6	1	2014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVOXAMINE MALEATE	ACTIVE INGREDIENT	5LGN83G74V	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FLUVOXAMINE	ACTIVE MOIETY	O4L1XPO44W	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
AMMONIO METHACRYLATE COPOLYMER TYPE A	INACTIVE INGREDIENT	8GQS4E66YY	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
AMMONIO METHACRYLATE COPOLYMER TYPE B	INACTIVE INGREDIENT	161H3B14U2	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0228-2849	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ACTAVIS PHARMA, INC.]	19	Current NDC, Legacy NDC, 1 package rows	20250516_8bbd7e39-b9ab-4716-9522-aa8c4b92210e.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 · 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
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 ndc (product): 0228-2849

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	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
903879	fluvoxaMINE maleate 150 MG 24HR Extended Release Oral Capsule	PSN	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
903873	24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule	SCD	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
903879	24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule	SCD	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
903873	fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule	SY	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
903879	fluvoxamine maleate 150 MG 24 HR Extended Release Oral Capsule	SY	8bbd7e39-b9ab-4716-9522-aa8c4b92210e	21
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	Status
0228-2849-00	00228284900	8759 CAPSULE, EXTENDED RELEASE in 1 CONTAINER (0228-2849-00)	14-FEB-25	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine Maleate	AvKARE	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	1
Fluvoxamine Maleate	Actavis Pharma, Inc.	2025-05-28	HUMAN PRESCRIPTION DRUG LABEL	20