Fluvoxamine Maleate

Product NDC: 69452-183
11-digit product format: 694520183
Labeler code: 69452
Product ID: 69452-183_19874c71-b387-6008-e063-6294a90ab365
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Fluvoxamine Maleate
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Bionpharma Inc.
Application: ANDA212182
Marketing category: ANDA
Marketing start: 2020-07-01
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
A212182-001	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-05-11
A212182-002	FLUVOXAMINE MALEATE	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB		2020-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212182-001	AB
A212182-002	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 2 · 74 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	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-09-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2020-09-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2020-09-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212182-001	FLUVOXAMINE MALEATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB	2020-05-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212182-002	FLUVOXAMINE MALEATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL		2020-09-16	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 71 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	A212182-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212182-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212182-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212182-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212182-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212182-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212182-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212182-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212182-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212182-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212182-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212182-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212182-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212182-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212182-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212182-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212182-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212182-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212182-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212182-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212182-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212182-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212182-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212182-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212182-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212182-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212182-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212182-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212182-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212182-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212182-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212182-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212182-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212182-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212182-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212182-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212182-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212182-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A212182-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212182-001	AB	1	`8869cabd3fbd…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	Bionpharma Inc.	9924422b-7c90-42bf-a680-ffd92063d5f0	2024-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212182 application number: ANDA212182 ndc (product): 69452-183

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
9924422b-7c90-42bf-a680-ffd92063d5f0	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
69452-183-13	Fluvoxamine Maleate	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30		3
69452-183-32	Fluvoxamine Maleate	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69452-183-13	EA - Each	69452-183	affc159b-16c3-4323-a825-60a0b9244f63	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69452-183	FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [BIONPHARMA INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240530_9924422b-7c90-42bf-a680-ffd92063d5f0.zip

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	9924422b-7c90-42bf-a680-ffd92063d5f0	3
903879	fluvoxaMINE maleate 150 MG 24HR Extended Release Oral Capsule	PSN	9924422b-7c90-42bf-a680-ffd92063d5f0	3
903873	24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule	SCD	9924422b-7c90-42bf-a680-ffd92063d5f0	3
903879	24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule	SCD	9924422b-7c90-42bf-a680-ffd92063d5f0	3
903873	fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule	SY	9924422b-7c90-42bf-a680-ffd92063d5f0	3
903879	fluvoxamine maleate 150 MG 24 HR Extended Release Oral Capsule	SY	9924422b-7c90-42bf-a680-ffd92063d5f0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69452-183-13	69452018313	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-183-13)	2020-07-01	0000-00-00	No	No	Current
69452-183-32	69452018332	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-183-32)	2020-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Fluvoxamine Maleate	Bionpharma Inc. \| OrBion Pharmaceuticals Private Limited	2024-05-28	HUMAN PRESCRIPTION DRUG LABEL	3