FDA.reportPublic FDA data

Fluvoxamine maleate

Product NDC
69452-288
Requested package NDC
69452-288-20
11-digit product format
694520288
Labeler code
69452
Product ID
69452-288_2fa05c01-e84f-99b2-e063-6394a90af57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217917
Marketing category
ANDA
Marketing start
2024-05-23
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
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217917-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE25MGTABLET / ORALAB2024-01-22
A217917-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE50MGTABLET / ORALAB2024-01-22
A217917-003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGTABLET / ORALAB2024-01-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217917-001AB
A217917-002AB
A217917-003AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A217917-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2024-01-22a50c72e98297…
2026-08-01 22:54:322026-06A217917-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2024-01-22a50c72e98297…
2026-08-01 22:54:322026-06A217917-003FLUVOXAMINE MALEATE100MGTABLET / ORALAB2024-01-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A217917-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A217917-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A217917-003AB1a50c72e98297…

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutions35b377d9-5b7a-4d8e-b6c1-4291d02f5dae2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.642b7b5e-9f1c-479b-b9b3-bf06774f7b602025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.191912e6-b3c8-be1a-e063-6394a90a8dd42025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917
ndc (package): 69452-288-20
ndc (product): 69452-288
ndc11 (package): 69452028820
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.2df4f9cf-5803-d8ea-e063-6394a90ad8552025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217917
application number: ANDA217917

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5LGN83G74VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903884Internal RxNorm lookup
903887Internal RxNorm lookup
903891Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
191912e6-b3c8-be1a-e063-6394a90a8dd4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234dProduct name320250515
0b12fd59-0eda-41d5-8618-6195bcd36a86Product name120250114
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-288-20Fluvoxamine maleate100 in 1 BOTTLETABLET1002
69452-288-30Fluvoxamine maleate500 in 1 BOTTLETABLET5002
69452-288-32Fluvoxamine maleate1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-288-20EA - Each69452-288b8356af5-cfa5-4bbb-917f-c2816ffc9ac112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-288FLUVOXAMINE MALEATE TABLET, FILM COATED FLUVOXAMINE MALEATE TABLET [BIONPHARMA INC.]2Current NDC, 3 package rows20250308_191912e6-b3c8-be1a-e063-6394a90a8dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903887fluvoxaMINE maleate 25 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903891fluvoxaMINE maleate 50 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903884fluvoxamine maleate 100 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42
903887fluvoxamine maleate 25 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42
903891fluvoxamine maleate 50 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-288-2069452028820100 TABLET in 1 BOTTLE (69452-288-20) 100 tablet2024-05-23NoNoCurrent