FDA.reportPublic FDA data

NDC 50090-7728-00 - 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
50090-7728
Requested NDC
50090-7728-00
Package NDCs from labels
50090-7728-0, 50090-7728-00
Manufacturer
A-S Medication Solutions
Effective date
2025-10-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fluvoxamine maleate - A-S Medication SolutionsA-S Medication Solutions2025-10-21HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7728-0Fluvoxamine maleate90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7728-0EA - Each50090-77287f24b181-a440-4cfc-a26c-1efc7ab7130012025-12-16

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 2 · 40 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
unii: 5LGN83G74V
Fluvoxamine maleate extended-releaseFLUVOXAMINE MALEATE EXTENDED-RELEASEZydus Pharmaceuticals USA Inc.6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
Fluvoxamine MaleateFLUVOXAMINE MALEATEPar Health USA, LLCd492230c-f56a-4759-ba86-7090b9f440632026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
Fluvoxamine MaleateFLUVOXAMINE MALEATEAmerican Health Packaging0b107225-ed5a-4461-9184-f3f2bad1892f2026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.5198b1c8-8dd6-4b8f-bd85-294ac468af532026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
Fluvoxamine MaleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.a4e0212a-ce68-4466-a0e4-f87d5d9ff0b32026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
unii: 5LGN83G74V
fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals, Inc.b5b2128d-2363-4966-971f-83219755ecd72026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
unii: 5LGN83G74V
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Fluvoxamine maleateFLUVOXAMINE MALEATEBryant Ranch Prepackc3d59ca9-dd42-4b1c-bd2d-23eb507598b82026-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA217917
rxcui: 903884
unii: 5LGN83G74V
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack4239fc32-e5cb-4393-b90c-742db42b5d072026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
unii: 5LGN83G74V
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack47daea9e-545d-4a67-b2b2-d12c3c98734b2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.88b5207a-d87b-4541-ac6b-aa1c51715fcf2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 903884
unii: 5LGN83G74V
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Fluvoxamine MaleateFLUVOXAMINE MALEATEAvKARE4527a684-51c0-1858-e063-6394a90a26312025-12-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5LGN83G74V
QR PAINANALGESICMARYHELENE ENTERPRISES INC8f8f53e3-fe31-e7b5-e053-2995a90a710d2025-11-14WarningsExact identifier
unii: 3OWL53L36A
QR PAINANALGESICMARYHELENE ENTERPRISES INC9984a510-30be-4013-e053-2995a90a841e2025-11-14WarningsExact identifier
unii: 3OWL53L36A
MannitolMANNITOLProPharma Distribution430669d7-9ad1-9a04-e063-6394a90ababb2025-11-07Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A

Reported adverse events (FAERS/openFDA)#

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