Fluvoxamine Maleate (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

Fluvoxamine Maleate Tablets USP, 25 mg
NDC 62559-158-01
Rx only
100 Tablets

Label-25mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Fluvoxamine Maleate Tablets USP, 50 mg
NDC 62559-159-01
Rx only
100 Tablet
s

Label-50mg
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Fluvoxamine Maleate Tablets USP, 100 mg
NDC 62559-160-01
Rx only
100 Tablets

Label-100mg
(click image for full-size original)

FLUVOXAMINE MALEATE fluvoxamine maleate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-158
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE (FLUVOXAMINE) FLUVOXAMINE MALEATE 25 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
STARCH, POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 9mm
Flavor Imprint Code 1222
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-158-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021519 08/09/2011
FLUVOXAMINE MALEATE fluvoxamine maleate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUVOXAMINE MALEATE (FLUVOXAMINE) FLUVOXAMINE MALEATE 50 mg
Inactive Ingredients
Ingredient Name Strength
MANNITOL
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
STARCH, POTATO
TALC
TITANIUM DIOXIDE
FERRIC OXIDE YELLOW
Product Characteristics
Color YELLOW Score 2 pieces
Shape OVAL Size 12mm
Flavor Imprint Code 1225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-159-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021519 08/09/2011
FLUVOXAMINE MALEATE fluvoxamine maleate tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62559-160
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
MANNITOL
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
SILICON DIOXIDE
SODIUM STEARYL FUMARATE
STARCH, CORN
STARCH, POTATO
TALC
TITANIUM DIOXIDE
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Product Characteristics
Color WHITE (beige) Score 2 pieces
Shape OVAL Size 15mm
Flavor Imprint Code 1221
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62559-160-01 100 TABLET, COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA021519 08/09/2011
Labeler — ANI Pharmaceuticals, Inc. (145588013)

Revised: 09/2021 ANI Pharmaceuticals, Inc.

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