FDA.reportPublic FDA data

fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule

RxCUI
903873
RxNorm name
fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule
Display name
fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule
Full name
fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule
Term type
SY
Status
DailyMed mapping
Updated
2026-06-04 23:39:22

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 0 matching rows.

No records found.

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine maleate extended-releaseFLUVOXAMINE MALEATE EXTENDED-RELEASEZydus Lifesciences Limited1f172569-9110-44df-acc5-0367e37ed7842026-07-22Exact identifier
rxcui: 903873
Fluvoxamine maleate extended-releaseFLUVOXAMINE MALEATE EXTENDED-RELEASEZydus Pharmaceuticals USA Inc.6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATEPar Health USA, LLCd492230c-f56a-4759-ba86-7090b9f440632026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATEAvKARE4527a684-51c0-1858-e063-6394a90a26312025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATEAjanta Pharma USA Inc.0a6836ab-bd0e-410b-82af-07720e3865322025-11-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATECamber Pharmaceuticals, Inc.e5574f41-d4df-42d5-baae-b317fb7c88bf2025-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATEActavis Pharma, Inc.8bbd7e39-b9ab-4716-9522-aa8c4b92210e2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873
Fluvoxamine MaleateFLUVOXAMINE MALEATEBionpharma Inc.9924422b-7c90-42bf-a680-ffd92063d5f02024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903873

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
d492230c-f56a-4759-ba86-7090b9f44063fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]326These 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: 200820231031
8bbd7e39-b9ab-4716-9522-aa8c4b92210efluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]321These 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 use Initial U.S. Approval: 200820250501
0a6836ab-bd0e-410b-82af-07720e386532fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]33These 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 use Initial U.S. Approval: 200820251104
9924422b-7c90-42bf-a680-ffd92063d5f0fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]33These 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 use Initial U.S. Approval: 200820240528
4527a684-51c0-1858-e063-6394a90a2631fluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]31Fluvoxamine Maleate Extended-Release Capsules 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. Initial U.S. Approval: 200820251204
e5574f41-d4df-42d5-baae-b317fb7c88bffluvoxaMINE maleate 100 MG 24HR Extended Release Oral Capsule [PSN] · 24 HR fluvoxamine maleate 100 MG Extended Release Oral Capsule [SCD] · fluvoxamine maleate 100 MG 24 HR Extended Release Oral Capsule [SY]31These 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: 200820250830