Fluoxetine (Page 13 of 13)


7
Not approved for use in children

PRINCIPAL DISPLAY PANEL — 10 mg Capsule Bottle Label

NDC 69367-235-01
RX Only

Fluoxetine
Capsules, USP

10 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Capsules

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 10 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Capsule Bottle Label

NDC 69367-236-01
RX Only

Fluoxetine
Capsules, USP

20 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Capsules

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 20 mg Capsule Bottle Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 40 mg Capsule Bottle Label

NDC 69367-237-01
RX Only

Fluoxetine
Capsules, USP

40 mg

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

100 Capsules

WestminsterPharmaceuticals

PRINCIPAL DISPLAY PANEL -- 40 mg Capsule Bottle Label
(click image for full-size original)
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-235
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
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Opaque Light Blue) , ORANGE (Opaque Light Orange) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code SG;113
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-235-01 100 CAPSULE in 1 BOTTLE None
2 NDC:69367-235-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204597 09/25/2019
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-236
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
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Opaque Light Blue) , GREEN (Opaque Light Green) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code SG;114
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-236-01 100 CAPSULE in 1 BOTTLE None
2 NDC:69367-236-10 1000 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204597 09/25/2019
FLUOXETINE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69367-237
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
SILICON DIOXIDE
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
FD&C BLUE NO. 1
FD&C RED NO. 3
TITANIUM DIOXIDE
FD&C YELLOW NO. 6
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
PROPYLENE GLYCOL
SHELLAC
AMMONIA
Product Characteristics
Color BLUE (Opaque Light Blue) , WHITE (Opaque White) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code SG;115
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69367-237-01 100 CAPSULE in 1 BOTTLE None
2 NDC:69367-237-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA204597 09/25/2019
Labeler — Westminster Pharmaceuticals, LLC (079516651)

Revised: 11/2021 Westminster Pharmaceuticals, LLC

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