Fluvoxamine Maleate

Product NDC
62135-932
11-digit product format
621350932
Labeler code
62135
Product ID
62135-932_2c617129-3c30-3713-e063-6294a90af923
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA075900
Marketing category
ANDA
Marketing start
2006-02-23
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

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 Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903884, 903887, 903891

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
62135-932-60Fluvoxamine Maleate60 in 1 BOTTLETABLET, FILM COATED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-932FLUVOXAMINE MALEATE TABLET, FILM COATED [CHARTWELL RX, LLC]2Current NDC, 1 package rows20250125_b8320308-084f-43fb-9b1d-5620a0efaf46.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSNb8320308-084f-43fb-9b1d-5620a0efaf462
903887fluvoxaMINE maleate 25 MG Oral TabletPSNb8320308-084f-43fb-9b1d-5620a0efaf462
903891fluvoxaMINE maleate 50 MG Oral TabletPSNb8320308-084f-43fb-9b1d-5620a0efaf462
903884fluvoxamine maleate 100 MG Oral TabletSCDb8320308-084f-43fb-9b1d-5620a0efaf462
903887fluvoxamine maleate 25 MG Oral TabletSCDb8320308-084f-43fb-9b1d-5620a0efaf462
903891fluvoxamine maleate 50 MG Oral TabletSCDb8320308-084f-43fb-9b1d-5620a0efaf462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-932-606213509326060 TABLET, FILM COATED in 1 BOTTLE (62135-932-60) 2024-12-18NoNoCurrent