FDA.reportPublic FDA data

Fluvoxamine Maleate

Product NDC
69452-182
11-digit product format
694520182
Labeler code
69452
Product ID
69452-182_19874c71-b387-6008-e063-6294a90ab365
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fluvoxamine Maleate
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bionpharma Inc.
Application
ANDA212182
Marketing category
ANDA
Marketing start
2020-12-01
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A212182-001FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-11
A212182-002FLUVOXAMINE MALEATEFLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A212182-001AB
A212182-002AB

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
2026-08-01 22:54:322026-06A212182-001FLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2020-05-11a50c72e98297…
2026-08-01 22:54:322026-06A212182-002FLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2020-09-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A212182-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A212182-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fluvoxamine MaleateFLUVOXAMINE MALEATEBionpharma Inc.9924422b-7c90-42bf-a680-ffd92063d5f02024-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 212182
application number: ANDA212182
ndc (product): 69452-182

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 · 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
9924422b-7c90-42bf-a680-ffd92063d5f0Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69452-182-13Fluvoxamine Maleate30 in 1 BOTTLECAPSULE, EXTENDED RELEASE303
69452-182-32Fluvoxamine Maleate1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69452-182-13EA - Each69452-182c04089f0-4c99-4315-a4e5-158a39a005f712024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-182FLUVOXAMINE MALEATE CAPSULE, EXTENDED RELEASE [BIONPHARMA INC.]3Current NDC, Legacy NDC, 2 package rows20240530_9924422b-7c90-42bf-a680-ffd92063d5f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
903873fluvoxaMINE maleate 100 MG 24HR Extended Release Oral CapsulePSN9924422b-7c90-42bf-a680-ffd92063d5f03
903879fluvoxaMINE maleate 150 MG 24HR Extended Release Oral CapsulePSN9924422b-7c90-42bf-a680-ffd92063d5f03
90387324 HR fluvoxamine maleate 100 MG Extended Release Oral CapsuleSCD9924422b-7c90-42bf-a680-ffd92063d5f03
90387924 HR fluvoxamine maleate 150 MG Extended Release Oral CapsuleSCD9924422b-7c90-42bf-a680-ffd92063d5f03
903873fluvoxamine maleate 100 MG 24 HR Extended Release Oral CapsuleSY9924422b-7c90-42bf-a680-ffd92063d5f03
903879fluvoxamine maleate 150 MG 24 HR Extended Release Oral CapsuleSY9924422b-7c90-42bf-a680-ffd92063d5f03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69452-182-136945201821330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-13) 2020-12-010000-00-00NoNoCurrent
69452-182-32694520182321000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69452-182-32) 2020-12-010000-00-00NoNoCurrent