FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
27241-274
11-digit product format
272410274
Labeler code
27241
Product ID
27241-274_658eeffd-e919-4d41-8814-e55273a471e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA219055
Marketing category
ANDA
Marketing start
2024-10-17
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
27241-274-30Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-274-30EA - Each27241-274d7942025-075b-49be-88fa-51da73f7ee8a12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-274FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [AJANTA PHARMA USA INC.]2Current NDC, 1 package rows20241020_0a6836ab-bd0e-410b-82af-07720e386532.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN0a6836ab-bd0e-410b-82af-07720e3865323
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN0a6836ab-bd0e-410b-82af-07720e3865323
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD0a6836ab-bd0e-410b-82af-07720e3865323
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD0a6836ab-bd0e-410b-82af-07720e3865323
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY0a6836ab-bd0e-410b-82af-07720e3865323
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY0a6836ab-bd0e-410b-82af-07720e3865323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
27241-274-302724102743030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (27241-274-30) 2024-10-17NoNoCurrent