fluvoxamine maleate

Product NDC
68071-2337
11-digit product format
680712337
Labeler code
68071
Product ID
68071-2337_ba0e263a-1ed7-9c0a-e053-2995a90a9fed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
NDA021519
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-08-09
Marketing end
0000-00-00
Substance
FLUVOXAMINE MALEATE
Active strength
50 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68071-2337IInactivated by FDA2026-08-03
excluded packagepackage68071-233768071-2337-1IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68071-2337-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68071-2337-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68071-2337-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68071-2337-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68071-2337-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68071-2337-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68071-2337-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68071-2337-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68071-2337-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68071-2337-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68071-2337-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68071-2337-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-2337-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-2337-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-2337-11332a3947898…d4bfe170f9cd…

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…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2337-1fluvoxamine maleate100 in 1 BOTTLETABLET, COATED1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2337FLUVOXAMINE MALEATE TABLET, COATED [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC, 1 package rows20210130_ba0de917-bfb8-d350-e053-2a95a90ac90f.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
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
903891fluvoxaMINE maleate 50 MG Oral TabletPSNba0de917-bfb8-d350-e053-2a95a90ac90f1
903891fluvoxamine maleate 50 MG Oral TabletSCDba0de917-bfb8-d350-e053-2a95a90ac90f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2337-168071233701100 TABLET, COATED in 1 BOTTLE (68071-2337-1) 2021-01-290000-00-00NoNoCurrent