FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
10370-175
11-digit product format
103700175
Labeler code
10370
Product ID
10370-175_43df09bd-f0c3-4635-8242-4d2110138b84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA091476
Marketing category
ANDA
Marketing start
2013-03-13
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10370-175-102022-10-05C16284748780-1e4f33bdf-9b30-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-175-112022-10-05C16284748780-1e4f33bdf-9b30-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-175-102022-07-29C16284748780-1e4f33bdf-9b30-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008
10370-175-112022-07-29C16284748780-1e4f33bdf-9b30-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for FLUVOXAMINE MALEATE EXTENDED-RELEASE CAPSULES. FLUVOXAMINE MALEATE extended-release capsules, for oral administration Initial U.S. Approval: 2008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10370-175-10Fluvoxamine Maleate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100026
10370-175-11Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3026

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10370-175-11EA - Each10370-175cc0f78d9-7736-43b4-a0a6-b6a65d7608c312013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
ALCOHOLINACTIVE INGREDIENT3K9958V90MFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
GELATININACTIVE INGREDIENT2G86QN327LFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
HYDROXYPROPYL CELLULOSE (TYPE E)INACTIVE INGREDIENT66O7AQV0RTFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
SHELLACINACTIVE INGREDIENT46N107B71OFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
SUCROSEINACTIVE INGREDIENTC151H8M554FLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
TALCINACTIVE INGREDIENT7SEV7J4R1UFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMFLUVOXAMINE MALEATE EXTENDED-RELEASE (FLUVOXAMINE MALEATE) CAPSULE, EXTENDED RELEASE [PAR PHARMACEUTICAL, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10370-175FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [ENDO USA, INC.]26Current NDC, Legacy NDC, 2 package rows20241212_d492230c-f56a-4759-ba86-7090b9f44063.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSNd492230c-f56a-4759-ba86-7090b9f4406326
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSNd492230c-f56a-4759-ba86-7090b9f4406326
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCDd492230c-f56a-4759-ba86-7090b9f4406326
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCDd492230c-f56a-4759-ba86-7090b9f4406326
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSYd492230c-f56a-4759-ba86-7090b9f4406326
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSYd492230c-f56a-4759-ba86-7090b9f4406326

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10370-175-10103700175101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-10) 2013-03-130000-00-00NoNoCurrent
10370-175-111037001751130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-175-11) 2013-03-130000-00-00NoNoCurrent