Fluoxetine (Page 13 of 13)

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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 — 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 — 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

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