Fluoxetine Hydrochloride (Page 12 of 12)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 10mg

fluoxetine Tablets
(click image for full-size original)
fluoxetine tablets
(click image for full-size original)

fluoxetine tablets
(click image for full-size original)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 20mg

fluoxetine tablets
(click image for full-size original)

fluoxetine tabets
(click image for full-size original)

fluoxetine tablets
(click image for full-size original)

FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-335
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score 2 pieces
Shape OVAL (White to off-white, film-coated, oval-shaped tablets) Size 10mm
Flavor Imprint Code EP;360
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-335-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC None
2 NDC:49884-335-10 1000 TABLET, COATED in 1 BOTTLE, PLASTIC None
3 NDC:49884-335-11 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
4 NDC:49884-335-82 2000 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203836 08/22/2016
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride tablet, coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49884-336
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
STARCH, CORN
CROSPOVIDONE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color white Score 2 pieces
Shape OVAL (White to off-white, film-coated, oval-shaped tablets) Size 13mm
Flavor Imprint Code EP;362
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49884-336-01 100 TABLET, COATED in 1 BOTTLE, PLASTIC None
2 NDC:49884-336-10 1000 TABLET, COATED in 1 BOTTLE, PLASTIC None
3 NDC:49884-336-11 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
4 NDC:49884-336-82 2000 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA203836 08/22/2016
Labeler — Par Pharmaceutical, Inc. (092733690)

Revised: 06/2021 Par Pharmaceutical, Inc.

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