FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
60505-0164
Requested package NDC
60505-0164-2
11-digit product format
605050164
Labeler code
60505
Product ID
60505-0164_d1dc7389-27a2-60cd-7d33-9f0dd29a95b4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Apotex Corp
Application
ANDA075902
Marketing category
ANDA
Marketing start
2001-07-10
Substance
FLUVOXAMINE MALEATE
Active strength
25 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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60505-016460505-0164-2DDiscontinued by firm2026-07-31

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
A075902-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE25MGTABLET / ORALAB2001-05-07
A075902-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE50MGTABLET / ORALAB2001-05-07
A075902-003FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGTABLET / ORALAB2001-05-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075902-001AB
A075902-002AB
A075902-003AB

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 22:54:322026-06A075902-001FLUVOXAMINE MALEATE25MGTABLET / ORALAB2001-05-07a50c72e98297…
2026-08-01 22:54:322026-06A075902-002FLUVOXAMINE MALEATE50MGTABLET / ORALAB2001-05-07a50c72e98297…
2026-08-01 22:54:322026-06A075902-003FLUVOXAMINE MALEATE100MGTABLET / ORALAB2001-05-07a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075902-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075902-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A075902-003AB1a50c72e98297…

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 · 6 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
application applno (ANDA): 075902
application number: ANDA075902
Fluvoxamine MaleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals Inc.a4e0212a-ce68-4466-a0e4-f87d5d9ff0b32026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075902
application number: ANDA075902
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack4239fc32-e5cb-4393-b90c-742db42b5d072026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075902
application number: ANDA075902
Fluvoxamine MaleateFLUVOXAMINE MALEATEBryant Ranch Prepack47daea9e-545d-4a67-b2b2-d12c3c98734b2026-01-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075902
application number: ANDA075902
Fluvoxamine MaleateFLUVOXAMINE MALEATEPD-Rx Pharmaceuticals, Inc.9972efbb-46cd-45b7-b71c-35032311b70c2025-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075902
application number: ANDA075902
Fluvoxamine MaleateFLUVOXAMINE MALEATEApotex Corp6eeb14df-6fcf-a737-5359-5744eb4accea2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075902
application number: ANDA075902
ndc (package): 60505-0164-2
ndc (product): 60505-0164
ndc11 (package): 60505016402

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE25 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
6eeb14df-6fcf-a737-5359-5744eb4acceaAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60505-0164-1Fluvoxamine Maleate100 in 1 BOTTLETABLET10015
60505-0164-2Fluvoxamine Maleate1000 in 1 BOTTLETABLET100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-0164-1EA - Each60505-0164a7ed42f6-b3e2-445e-bc4b-b1412a01ac2512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)INACTIVE INGREDIENT8136Y38GY5FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30FLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE TABLET [APOTEX CORP]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-0164FLUVOXAMINE MALEATE TABLET [APOTEX CORP]14Current NDC, Legacy NDC, 2 package rows20240214_6eeb14df-6fcf-a737-5359-5744eb4accea.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903887fluvoxaMINE maleate 25 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903891fluvoxaMINE maleate 50 MG Oral TabletPSN6eeb14df-6fcf-a737-5359-5744eb4accea15
903884fluvoxamine maleate 100 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15
903887fluvoxamine maleate 25 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15
903891fluvoxamine maleate 50 MG Oral TabletSCD6eeb14df-6fcf-a737-5359-5744eb4accea15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-0164-2605050164021000 TABLET in 1 BOTTLE (60505-0164-2) 1000 tablet2001-07-100000-00-00NoNoCurrent