FDA.reportPublic FDA data

Fluvoxamine maleate

Product NDC
69452-288
11-digit product format
694520288
Labeler code
69452
Product ID
69452-288_2fa05c01-e84f-99b2-e063-6394a90af57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA217917
Marketing category
ANDA
Marketing start
2024-05-23
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-288-20Fluvoxamine maleate100 in 1 BOTTLETABLET1002
69452-288-30Fluvoxamine maleate500 in 1 BOTTLETABLET5002
69452-288-32Fluvoxamine maleate1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-288-20EA - Each69452-288b8356af5-cfa5-4bbb-917f-c2816ffc9ac112024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-288FLUVOXAMINE MALEATE TABLET, FILM COATED FLUVOXAMINE MALEATE TABLET [BIONPHARMA INC.]2Current NDC, 3 package rows20250308_191912e6-b3c8-be1a-e063-6394a90a8dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903887fluvoxaMINE maleate 25 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903891fluvoxaMINE maleate 50 MG Oral TabletPSN191912e6-b3c8-be1a-e063-6394a90a8dd42
903884fluvoxamine maleate 100 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42
903887fluvoxamine maleate 25 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42
903891fluvoxamine maleate 50 MG Oral TabletSCD191912e6-b3c8-be1a-e063-6394a90a8dd42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69452-288-2069452028820100 TABLET in 1 BOTTLE (69452-288-20) 100 tablet2024-05-23NoNoCurrent
69452-288-3069452028830500 TABLET in 1 BOTTLE (69452-288-30) 500 tablet2025-02-07NoNoCurrent
69452-288-32694520288321000 TABLET in 1 BOTTLE (69452-288-32) 1000 tablet2025-02-07NoNoCurrent