Fluvoxamine Maleate

Product NDC: 10370-176
Requested package NDC: 10370-176-28
11-digit product format: 103700176
Labeler code: 10370
Product ID: 10370-176_43df09bd-f0c3-4635-8242-4d2110138b84
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Endo USA, Inc.
Application: ANDA091476
Marketing category: ANDA
Marketing start: 2013-03-13
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
excluded package	package	10370-176	10370-176-28	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 · 10 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`

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
A091476-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-03-13
A091476-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2013-03-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091476-001	AB
A091476-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091476-001	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091476-002	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2013-03-13	`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	A091476-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091476-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091476-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091476-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091476-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091476-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091476-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091476-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091476-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091476-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091476-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091476-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091476-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091476-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091476-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091476-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091476-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091476-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091476-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091476-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091476-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091476-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091476-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091476-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091476-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091476-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091476-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091476-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091476-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091476-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091476-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091476-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091476-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091476-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091476-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091476-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091476-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091476-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091476-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091476-002	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
d492230c-f56a-4759-ba86-7090b9f44063	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
10370-176-11	2022-10-05	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-11	2022-10-05	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-28	2022-10-05	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-28	2022-10-05	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-11	2022-07-29	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-11	2022-07-29	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-28	2022-07-29	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-176-28	2022-07-29	These highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10370-176-11	Fluvoxamine Maleate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		26
10370-176-28	Fluvoxamine Maleate	750 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	750		26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10370-176-11	EA - Each	10370-176	6a1d3f1a-f2c7-45b4-9f25-0ee6643b15f8	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FLUVOXAMINE MALEATE	ACTIVE INGREDIENT	5LGN83G74V	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
FLUVOXAMINE	ACTIVE MOIETY	O4L1XPO44W	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
D&C RED NO. 28	INACTIVE INGREDIENT	767IP0Y5NH	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
GELATIN	INACTIVE INGREDIENT	2G86QN327L	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
SHELLAC	INACTIVE INGREDIENT	46N107B71O	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10370-176	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]	26	Current NDC, Legacy NDC, 2 package rows	20241212_d492230c-f56a-4759-ba86-7090b9f44063.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluvoxamine Maleate	FLUVOXAMINE MALEATE	Endo USA, Inc.	d492230c-f56a-4759-ba86-7090b9f44063	2023-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091476 application number: ANDA091476 ndc (package): 10370-176-28 ndc (product): 10370-176 ndc11 (package): 10370017628

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	d492230c-f56a-4759-ba86-7090b9f44063	26
903879	fluvoxaMINE maleate 150 MG 24HR Extended Release Oral Capsule	PSN	d492230c-f56a-4759-ba86-7090b9f44063	26
903873	24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule	SCD	d492230c-f56a-4759-ba86-7090b9f44063	26
903879	24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule	SCD	d492230c-f56a-4759-ba86-7090b9f44063	26
903873	fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule	SY	d492230c-f56a-4759-ba86-7090b9f44063	26
903879	fluvoxamine maleate 150 MG 24 HR Extended Release Oral Capsule	SY	d492230c-f56a-4759-ba86-7090b9f44063	26

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
10370-176-28	10370017628	750 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-28)	2013-03-13	0000-00-00	No	No	Current