fluvoxamine maleate

Product NDC
62559-160
11-digit product format
625590160
Labeler code
62559
Product ID
62559-160_cfb2098d-d30b-4a8e-84c1-aeb8065b519c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
NDA021519
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-08-09
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021519-001LUVOXFLUVOXAMINE MALEATE25MGTABLET / ORALABRLD2007-12-20
N021519-002LUVOXFLUVOXAMINE MALEATE50MGTABLET / ORALABRLD2007-12-20
N021519-003LUVOXFLUVOXAMINE MALEATE100MGTABLET / ORALABRLD2007-12-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N021519-001AB
N021519-002AB
N021519-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-002LUVOX50MGTABLET / ORALABRLD2007-12-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-003LUVOX100MGTABLET / ORALABRLD2007-12-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021519-001LUVOX25MGTABLET / ORALABRLD2007-12-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N021519-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021519-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021519-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021519-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021519-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021519-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021519-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021519-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021519-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021519-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021519-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021519-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021519-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021519-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021519-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N021519-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021519-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021519-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021519-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021519-001AB18072bd15b7f6…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5LGN83G74VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903884Internal RxNorm lookup
903887Internal RxNorm lookup
903891Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7ecd83ec-88f5-4f85-9cc2-9068375d8820Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf9608ac-e3cb-2ff5-9afb-dc9a0d25234dProduct name320250515
0b12fd59-0eda-41d5-8618-6195bcd36a86Product name120250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-160-01fluvoxamine maleate100 in 1 BOTTLETABLET, COATED10016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-160-01EA - Each62559-160507c127c-7ec1-48a2-9366-f9dad4f97d6812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FLUVOXAMINE MALEATEACTIVE INGREDIENT5LGN83G74VFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FLUVOXAMINEACTIVE MOIETYO4L1XPO44WFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
MANNITOLINACTIVE INGREDIENT3OWL53L36AFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UIFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-160FLUVOXAMINE MALEATE TABLET, COATED [ANI PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 1 package rows20230823_7ecd83ec-88f5-4f85-9cc2-9068375d8820.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.5198b1c8-8dd6-4b8f-bd85-294ac468af532026-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021519
application number: NDA021519
fluvoxamine maleateFLUVOXAMINE MALEATEPreferred Pharmaceuticals, Inc.b5b2128d-2363-4966-971f-83219755ecd72026-04-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021519
application number: NDA021519
fluvoxamine maleateFLUVOXAMINE MALEATEREMEDYREPACK INC.88b5207a-d87b-4541-ac6b-aa1c51715fcf2026-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021519
application number: NDA021519
fluvoxamine maleateFLUVOXAMINE MALEATEANI Pharmaceuticals, Inc.7ecd83ec-88f5-4f85-9cc2-9068375d88202025-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021519
application number: NDA021519
ndc (product): 62559-160
fluvoxamine maleateFLUVOXAMINE MALEATEA-S Medication Solutionsddc9e7e8-f041-43bb-970b-cd4b303676372025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 021519
application number: NDA021519

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903884fluvoxaMINE maleate 100 MG Oral TabletPSN88b5207a-d87b-4541-ac6b-aa1c51715fcf18
903884fluvoxamine maleate 100 MG Oral TabletSCD88b5207a-d87b-4541-ac6b-aa1c51715fcf18
903884fluvoxaMINE maleate 100 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903887fluvoxaMINE maleate 25 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903891fluvoxaMINE maleate 50 MG Oral TabletPSN7ecd83ec-88f5-4f85-9cc2-9068375d882016
903884fluvoxamine maleate 100 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016
903887fluvoxamine maleate 25 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016
903891fluvoxamine maleate 50 MG Oral TabletSCD7ecd83ec-88f5-4f85-9cc2-9068375d882016
903884fluvoxaMINE maleate 100 MG Oral TabletPSNb5b2128d-2363-4966-971f-83219755ecd79
903884fluvoxamine maleate 100 MG Oral TabletSCDb5b2128d-2363-4966-971f-83219755ecd79
903884fluvoxaMINE maleate 100 MG Oral TabletPSNddc9e7e8-f041-43bb-970b-cd4b303676376
903884fluvoxamine maleate 100 MG Oral TabletSCDddc9e7e8-f041-43bb-970b-cd4b303676376

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62559-160-0162559016001100 TABLET, COATED in 1 BOTTLE (62559-160-01) 2011-08-090000-00-00NoNoCurrent