Fluoxetine (Page 13 of 13)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25000-147-03

Fluoxetine Capsules, USP 10 mg

30 count bottle label

fluox-10mg-30ct
(click image for full-size original)

NDC 25000-147-08

Fluoxetine Capsules, USP 10 mg

100 count bottle label

fluox-10mg-100ct
(click image for full-size original)

NDC 25000-148-08

Fluoxetine Capsules, USP 20 mg

100 count bottle label

fluox-20mg-100ct
(click image for full-size original)

NDC 25000-148-14

Fluoxetine Capsules, USP 20 mg

1000 count bottle label

fluox-20mg-1000ct
(click image for full-size original)

NDC 25000-149-12

Fluoxetine Capsules, USP 40 mg

500 count bottle label

fluox-40mg-500ct
(click image for full-size original)
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-147
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
STARCH, CORN
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
SHELLAC
POVIDONE, UNSPECIFIED
SODIUM HYDROXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (opaque light blue cap and opaque light blue body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code FLUOXETINE10mg;R147
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-147-03 30 CAPSULE in 1 BOTTLE None
2 NDC:25000-147-08 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075465 01/29/2022
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-148
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
STARCH, CORN
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
SHELLAC
POVIDONE, UNSPECIFIED
SODIUM HYDROXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (opaque light blue cap and opaque light torquoise blue body) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code FLUOXETINE20mg;R148
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-148-08 100 CAPSULE in 1 BOTTLE None
2 NDC:25000-148-14 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075465 01/29/2022
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-149
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 40 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SODIUM LAURYL SULFATE
SHELLAC
POVIDONE, UNSPECIFIED
SODIUM HYDROXIDE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
Product Characteristics
Color BLUE (opaque light blue cap and opaque white body) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code FLUOXETINE40mg;R149
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-149-12 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075465 01/29/2022
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-147), MANUFACTURE (25000-148), MANUFACTURE (25000-149)

Revised: 06/2022 MARKSANS PHARMA LIMITED

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