FDA.reportPublic FDA data

Fluvoxamine maleate extended-release

Product NDC
70710-1847
Requested package NDC
70710-1847-3
11-digit product format
707101847
Labeler code
70710
Product ID
70710-1847_cba28687-9ade-400c-9d15-c7de1d2113be
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine maleate extended-release
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA220447
Marketing category
ANDA
Marketing start
2026-08-04
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220447-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21
A220447-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A220447-001AB
A220447-002AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A220447-001FLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-2184e616aacf4f…
2026-09-14 22:38:342026-08A220447-002FLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-2184e616aacf4f…
2026-08-18 06:07:402026-07A220447-001FLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21caaa826d4ba7…
2026-08-18 06:07:402026-07A220447-002FLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A220447-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A220447-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A220447-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220447-002AB1caaa826d4ba7…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Fluvoxamine maleate extended-release
Listing expiration
2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
903873Internal RxNorm lookup
903879Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6c71d4f6-54b5-4d3a-8d2f-b7773c92c32eAvailable on FDA.report

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine maleate extended-releaseFLUVOXAMINE MALEATE EXTENDED-RELEASEZydus Lifesciences Limited1f172569-9110-44df-acc5-0367e37ed7842026-07-22Exact identifier
application applno (ANDA): 220447
application number: ANDA220447
Fluvoxamine maleate extended-releaseFLUVOXAMINE MALEATE EXTENDED-RELEASEZydus Pharmaceuticals USA Inc.6c71d4f6-54b5-4d3a-8d2f-b7773c92c32e2026-06-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 220447
application number: ANDA220447
ndc (package): 70710-1847-3
ndc (product): 70710-1847
ndc11 (package): 70710184703

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70710-1847-37071018470330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1847-3) 2026-08-04NoNoCurrent