Fluoxetine (Page 13 of 13)

Dr.Reddy’s Laboratories Inc. 20 June 2021

Fluoxetine Tablets USP, 20 mg — Container Label

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

FLUOXETINE
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
Contains

Packaging
#	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)

Establishment
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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Fluoxetine (Page 13 of 13)

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