FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
31722-065
11-digit product format
317220065
Labeler code
31722
Product ID
31722-065_3d922dc6-629d-73e8-e063-6294a90a7d09
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217024
Marketing category
ANDA
Marketing start
2025-07-30
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
31722-065-01Fluvoxamine Maleate100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001
31722-065-30Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-065-30EA - Each31722-06524817e63-a329-4f3d-9f14-d801636cbcf312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSNe5574f41-d4df-42d5-baae-b317fb7c88bf1
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSNe5574f41-d4df-42d5-baae-b317fb7c88bf1
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCDe5574f41-d4df-42d5-baae-b317fb7c88bf1
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCDe5574f41-d4df-42d5-baae-b317fb7c88bf1
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSYe5574f41-d4df-42d5-baae-b317fb7c88bf1
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSYe5574f41-d4df-42d5-baae-b317fb7c88bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
31722-065-0131722006501100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-01) 2025-07-30NoNoCurrent
31722-065-303172200653030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (31722-065-30) 2025-07-30NoNoCurrent