Fluoxetine (Page 13 of 13)

Fluoxetine Tablets USP, 20 mg — Container Label

Unvarnished Area consists of: 2D Barcode, Lot Number, Expiry Date and Serial Number.

(click image for full-size original)
fluoxetine tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43598-566
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
silicon dioxide
croscarmellose sodium
magnesium stearate
cellulose, microcrystalline
starch, corn
Hypromellose, Unspecified
Polyethylene Glycol, Unspecified
titanium dioxide
Product Characteristics
Color WHITE (white to off white) Score 2 pieces
Shape OVAL Size 4mm
Flavor Imprint Code 566;20
# Item Code Package Description Multilevel Packaging
1 NDC:43598-566-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43598-566-01 100 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:43598-566-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076006 05/08/2018
Labeler — Dr.Reddy’s Laboratories Inc. (802315887)
Name Address ID/FEI Operations
Dr.Reddy’s Laboratories Limited-FTO3 918608162 analysis (43598-566), manufacture (43598-566)

Revised: 06/2021 Dr.Reddy’s Laboratories Inc.

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