FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
73190-067
11-digit product format
731900067
Labeler code
73190
Product ID
73190-067_45279386-bef9-3bab-e063-6294a90aee92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvKARE
Application
ANDA091482
Marketing category
ANDA
Marketing start
2025-12-04
Substance
FLUVOXAMINE MALEATE
Active strength
150 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 MALEATE150 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
73190-067-30Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73190-067-30EA - Each73190-067ee1e9535-ccbc-43dc-9381-bcc1a190361312026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN4527a684-51c0-1858-e063-6394a90a26311
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN4527a684-51c0-1858-e063-6394a90a26311
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD4527a684-51c0-1858-e063-6394a90a26311
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD4527a684-51c0-1858-e063-6394a90a26311
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY4527a684-51c0-1858-e063-6394a90a26311
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY4527a684-51c0-1858-e063-6394a90a26311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73190-067-307319000673030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (73190-067-30) 2025-12-04NoNoCurrent