Fluvoxamine Maleate

Product NDC
72789-221
11-digit product format
727890221
Labeler code
72789
Product ID
72789-221_401e3db8-8a12-7d79-e063-6394a90a91f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA075902
Marketing category
ANDA
Marketing start
2001-07-10
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
Rxcui903884

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
72789-221-30Fluvoxamine Maleate30 in 1 BOTTLE, PLASTICTABLET3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-221FLUVOXAMINE MALEATE TABLET [PD-RX PHARMACEUTICALS, INC.]16Current NDC, Legacy NDC, 1 package rows20240719_9972efbb-46cd-45b7-b71c-35032311b70c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN9972efbb-46cd-45b7-b71c-35032311b70c17
903884fluvoxamine maleate 100 MG Oral TabletSCD9972efbb-46cd-45b7-b71c-35032311b70c17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-221-307278902213030 TABLET in 1 BOTTLE, PLASTIC (72789-221-30) 30 tablet2022-01-180000-00-00NoNoCurrent