FDA.reportPublic FDA data

NDC 63672-1025 - Fluvoxamine maleate

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
63672-1025
Package NDCs from labels
63672-1025-1, 63672-1025-2, 63672-1025-4
Manufacturer
Synthon Pharmaceuticals, Inc.
Effective date
2007-09-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluvoxamine Maleate TabletsSynthon Pharmaceuticals, Inc.2007-09-20HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63672-1025-1Fluvoxamine maleate30 in 1 BOTTLETABLET, FILM COATED302
63672-1025-2Fluvoxamine maleate100 in 1 BOTTLETABLET, FILM COATED1002
63672-1025-4Fluvoxamine maleate500 in 1 BOTTLETABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63672-1025FLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]23 package rows20070928_85B61F83-AB47-470D-8673-02FEA29247BE.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Fluvoxamine maleateACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
FluvoxamineACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
colloidal silicon dioxideINACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
HypromelloseINACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
polyethylene glycolINACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
pregelatinized starch (corn)INACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
sodium stearyl fumarateINACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
starch (corn)INACTIVE INGREDIENTFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE (FLUVOXAMINE MALEATE) TABLET, FILM COATED [SYNTHON PHARMACEUTICALS, INC.]2

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 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine MaleateFLUVOXAMINE MALEATEAmerican Health Packaging0b107225-ed5a-4461-9184-f3f2bad1892f2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.5198b1c8-8dd6-4b8f-bd85-294ac468af532026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
Fluvoxamine MaleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.a4e0212a-ce68-4466-a0e4-f87d5d9ff0b32026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals, Inc.b5b2128d-2363-4966-971f-83219755ecd72026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack4239fc32-e5cb-4393-b90c-742db42b5d072026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack47daea9e-545d-4a67-b2b2-d12c3c98734b2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.88b5207a-d87b-4541-ac6b-aa1c51715fcf2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutions35b377d9-5b7a-4d8e-b6c1-4291d02f5dae2025-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine MaleateFLUVOXAMINE MALEATEPD-Rx Pharmaceuticals, Inc.9972efbb-46cd-45b7-b71c-35032311b70c2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.642b7b5e-9f1c-479b-b9b3-bf06774f7b602025-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
fluvoxamine maleateFLUVOXAMINE MALEATEANI Pharmaceuticals, Inc.7ecd83ec-88f5-4f85-9cc2-9068375d88202025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
rxcui: 903884
rxcui: 903887
fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutionsddc9e7e8-f041-43bb-970b-cd4b303676372025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.191912e6-b3c8-be1a-e063-6394a90a8dd42025-03-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
rxcui: 903884
rxcui: 903887
Fluvoxamine maleateFLUVOXAMINE MALEATEBionpharma Inc.2df4f9cf-5803-d8ea-e063-6394a90ad8552025-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
rxcui: 903887
Fluvoxamine MaleateFLUVOXAMINE MALEATEChartwell RX, LLCb8320308-084f-43fb-9b1d-5620a0efaf462025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903891
rxcui: 903884
rxcui: 903887
3EF69001-31B8-234F-A0F5-F0B5EAC7667185B61F83-AB47-470D-8673-02FEA29247BE2007-09-20Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 3EF69001-31B8-234F-A0F5-F0B5EAC76671
spl set id: 85B61F83-AB47-470D-8673-02FEA29247BE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.