Fluvoxamine Maleate (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0228-2848-03

Once-a-Day

Fluvoxamine Maleate Extended-Release Capsules

100 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0228-2849-03

Once-a-Day

Fluvoxamine Maleate Extended-Release Capsules

150 mg

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

30 Capsules

FLUVOXAMINE MALEATE fluvoxamine maleate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2848 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUVOXAMINE MALEATE (FLUVOXAMINE) FLUVOXAMINE MALEATE 100 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE A AMMONIO METHACRYLATE COPOLYMER TYPE B FERROSOFERRIC OXIDE FD&C BLUE NO. 1 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) SODIUM LAURYL SULFATE SUCROSE STARCH, CORN TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC

Product Characteristics Color green (Olive Opaque Cap) , gray (Opaque Body) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 2848 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0228-2848-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091482 08/05/2014

FLUVOXAMINE MALEATE fluvoxamine maleate capsule, extended release

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0228-2849 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FLUVOXAMINE MALEATE (FLUVOXAMINE) FLUVOXAMINE MALEATE 150 mg

Inactive Ingredients Ingredient Name Strength AMMONIO METHACRYLATE COPOLYMER TYPE A AMMONIO METHACRYLATE COPOLYMER TYPE B FERROSOFERRIC OXIDE FD&C BLUE NO. 1 GELATIN HYDROXYPROPYL CELLULOSE (1600000 WAMW) SODIUM LAURYL SULFATE SUCROSE STARCH, CORN TALC TITANIUM DIOXIDE TRIETHYL CITRATE FERRIC OXIDE YELLOW POTASSIUM HYDROXIDE PROPYLENE GLYCOL SHELLAC

Product Characteristics Color white (Opaque Body) , green (Olive Opaque Cap) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code 2849 Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0228-2849-03 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091482 08/05/2014

Labeler — Actavis Pharma, Inc. (119723554)

Revised: 08/2023 Actavis Pharma, Inc.