FLUOXETINE (Page 8 of 8)

LABEL

100
(click image for full-size original)

FLUOXETINE
fluoxetine capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-100(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
MAGNESIUM STEARATE
STARCH, CORN
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:61919-100-30 30 CAPSULE in 1 BOTTLE None
2 NDC:61919-100-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076001 01/01/2014
Labeler — Direct_Rx (079254320)
Registrant — Direct_Rx (079254320)
Establishment
Name Address ID/FEI Operations
Direct_Rx 079254320 repack (61919-100)

Revised: 09/2019 Direct_Rx

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