Label: FLUVOXAMINE MALEATE EXTENDED-RELEASE capsule, extended release
- NDC Code(s): 70771-1957-3, 70771-1958-3
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated July 22, 2026
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INGREDIENTS AND APPEARANCE
FLUVOXAMINE MALEATE EXTENDED-RELEASE
fluvoxamine maleate extended-release capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1957 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W) FLUVOXAMINE MALEATE 100 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE ((blue opaque cap)) , WHITE ((White opaque body)) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 1847 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1957-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA220447 08/04/2026 FLUVOXAMINE MALEATE EXTENDED-RELEASE
fluvoxamine maleate extended-release capsule, extended releaseProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1958 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUVOXAMINE MALEATE (UNII: 5LGN83G74V) (FLUVOXAMINE - UNII:O4L1XPO44W) FLUVOXAMINE MALEATE 150 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 28 (UNII: 767IP0Y5NH) ETHYLCELLULOSE (UNII: 7Z8S9VYZ4B) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) GELATIN (UNII: 2G86QN327L) HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH) POTASSIUM HYDROXIDE (UNII: WZH3C48M4T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SHELLAC (UNII: 46N107B71O) STARCH, CORN (UNII: O8232NY3SJ) SUCROSE (UNII: C151H8M554) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) WATER (UNII: 059QF0KO0R) Product Characteristics Color BLUE ((blue opaque cap)) , WHITE ((White opaque body)) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 1848 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70771-1958-3 30 in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA220447 08/04/2026 Labeler - Zydus Lifesciences Limited (918596198) Establishment Name Address ID/FEI Business Operations Zydus Pharmaceuticals Limited 650173735 MANUFACTURE(70771-1957, 70771-1958) , ANALYSIS(70771-1957, 70771-1958)
