FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
68788-8175
11-digit product format
687888175
Labeler code
68788
Product ID
68788-8175_e8faf176-d195-4e5f-a7dc-a17a05985ec6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA075902
Marketing category
ANDA
Marketing start
2022-04-27
Substance
FLUVOXAMINE MALEATE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fluvoxamine Maleate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FLUVOXAMINE MALEATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903884

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
68788-8175-3Fluvoxamine Maleate30 in 1 BOTTLETABLET305
68788-8175-6Fluvoxamine Maleate60 in 1 BOTTLETABLET605
68788-8175-9Fluvoxamine Maleate90 in 1 BOTTLETABLET905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8175-3EA - Each68788-817547f37f91-2ea9-43dd-9e1f-15d05354797412022-07-06
68788-8175-6EA - Each68788-8175413dd5c5-7a7e-4b4a-8131-1ca59ef9fd0712022-07-06
68788-8175-9EA - Each68788-817593445f04-f534-47e5-b7ce-cd801808b89012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8175FLUVOXAMINE MALEATE TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240504_a4e0212a-ce68-4466-a0e4-f87d5d9ff0b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSNa4e0212a-ce68-4466-a0e4-f87d5d9ff0b35
903884fluvoxamine maleate 100 MG Oral TabletSCDa4e0212a-ce68-4466-a0e4-f87d5d9ff0b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8175-36878881750330 TABLET in 1 BOTTLE (68788-8175-3) 30 tablet2022-04-270000-00-00NoNoCurrent
68788-8175-66878881750660 TABLET in 1 BOTTLE (68788-8175-6) 60 tablet2022-04-270000-00-00NoNoCurrent
68788-8175-96878881750990 TABLET in 1 BOTTLE (68788-8175-9) 90 tablet2022-04-270000-00-00NoNoCurrent