FDA.reportPublic FDA data

FLUVOXAMINE MALEATE extended-release capsules, for oral use

Manufacturer
Zydus Lifesciences Limited | Zydus Pharmaceuticals Limited
Effective date
2026-07-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-05 06:01:43

Label at a glance#

ProductFluvoxamine maleate extended-release
Active ingredientFLUVOXAMINE MALEATE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fluvoxamine Maleate Extended -Release Capsules, 100 mg

NDC 70771-1957-3

Bottles of 30 capsules

Rx only

100 mg label
100 mg label

Fluvoxamine Maleate Extended -Release Capsules, 150 mg

NDC 70771-1958-3

Bottles of 30 capsules

Rx only

150 mg label
150 mg label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70771-195770771-1957-3
70771-195870771-1958-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
FLUVOXAMINE MALEATE5LGN83G74VACTIB
D&C RED NO. 28767IP0Y5NHIACT
ETHYLCELLULOSE7Z8S9VYZ4BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
STARCH, CORNO8232NY3SJIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
WATER059QF0KO0RIACT
FLUVOXAMINE MALEATE5LGN83G74VACTIB
D&C RED NO. 28767IP0Y5NHIACT
ETHYLCELLULOSE7Z8S9VYZ4BIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
GELATIN2G86QN327LIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
POTASSIUM HYDROXIDEWZH3C48M4TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SHELLAC46N107B71OIACT
STARCH, CORNO8232NY3SJIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIETHYL CITRATE8Z96QXD6UMIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
2026-10-15 13:18:302026-09A220447-001FLUVOXAMINE MALEATE100MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21c2088c7a36db…
2026-10-15 13:18:302026-09A220447-002FLUVOXAMINE MALEATE150MGCAPSULE, EXTENDED RELEASE / ORALAB2026-07-21c2088c7a36db…
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
2026-10-15 13:18:302026-09A220447-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A220447-002AB1c2088c7a36db…
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…

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 · 1 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
ndc (package): 70771-1957-3
ndc (package): 70771-1958-3
ndc (product): 70771-1957
ndc (product): 70771-1958
ndc11 (package): 70771195803
ndc11 (package): 70771195703
spl id: d45aa001-af6b-41f2-ac88-c72411621202
spl set id: 1f172569-9110-44df-acc5-0367e37ed784

Reported adverse events (FAERS/openFDA)#

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