FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
69452-182
11-digit product format
694520182
Labeler code
69452
Product ID
69452-182_19874c71-b387-6008-e063-6294a90ab365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA212182
Marketing category
ANDA
Marketing start
2020-12-01
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
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 MALEATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5LGN83G74V
Rxcui903873, 903879

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
69452-182-13Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
69452-182-32Fluvoxamine Maleate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-182-13EA - Each69452-182c04089f0-4c99-4315-a4e5-158a39a005f712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-182FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20240530_9924422b-7c90-42bf-a680-ffd92063d5f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN9924422b-7c90-42bf-a680-ffd92063d5f03
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN9924422b-7c90-42bf-a680-ffd92063d5f03
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD9924422b-7c90-42bf-a680-ffd92063d5f03
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD9924422b-7c90-42bf-a680-ffd92063d5f03
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY9924422b-7c90-42bf-a680-ffd92063d5f03
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY9924422b-7c90-42bf-a680-ffd92063d5f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-182-136945201821330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-13) 2020-12-010000-00-00NoNoCurrent
69452-182-32694520182321000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-32) 2020-12-010000-00-00NoNoCurrent