Fluoxetine (Page 13 of 13)

PRINCIPAL DISPLAY PANEL

Fluoxetine 20mg Capsules #30
(click image for full-size original)

Fluoxetine Capsules USP 20 mg 100s Label Text

NDC 50111-648 -01

FLUOXETINE
Capsules USP
20 mg*

PHARMACIST: Dispense the accompanying
Medication Guide to each patient.

Rx only

100 CAPSULES

TEVA

FLUOXETINE
fluoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66116-464(NDC:50111-648)
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
AMMONIA
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 1
GELATIN
STARCH, CORN
MAGNESIUM STEARATE
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code PLIVA;648
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66116-464-30 30 CAPSULE in 1 BOTTLE None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076001 01/29/2002
Labeler — MedVantx, Inc. (806427725)
Registrant — Pliva Inc. (118234421)
Establishment
Name Address ID/FEI Operations
Blenheim Pharmacal, Inc. 171434587 REPACK (66116-464)

Revised: 08/2013 MedVantx, Inc.

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