FLUOXETINE HYDROCHLORIDE capsule

Fluoxetine by

Drug Labeling and Warnings

Fluoxetine by is a Prescription medication manufactured, distributed, or labeled by Northwind Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

NDC: 51655-100-52

MFG: 65862-193-99

Fluoxetine Capsules

20 MG

30 Tablets

Rx Only

Lot# NW60950001

Exp. Date: 12/2016

Each capsule contains: Fluoxetine hydrochloride USP equivalent to 20 mg of fluoxetine

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in a tight, light-resistant conainer (See USP). Keep out of the reach of children.

Mfg. by: Aurobindo Pharma Ltd, India for

Aurobindo Pharma Inc. NJ, USA

Lot# FX2014013-A exp. 12/2016

Repackaged by: Northwind Pharmaceuticals, Indianapolis, IN 46256

WARNINGS AND PRECAUTIONS

INGREDIENTS AND APPEARANCE

FLUOXETINE HYDROCHLORIDE 
fluoxetine hydrochloride capsule

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 51655-100(NDC:65862-193)
Route of Administration	oral

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FLUOXETINE HYDROCHLORIDE (UNII: I9W7N6B1KJ) (FLUOXETINE - UNII:01K63SUP8D)	FLUOXETINE	20 mg

Product Characteristics
Color	green, white	Score	no score
Shape	capsule	Size	16mm
Flavor		Imprint Code	E91
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51655-100-52	30 in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA078619	05/20/2014

Labeler - Northwind Pharmaceuticals (036986393)

Registrant - Northwind Pharmaceuticals (036986393)

Establishment
Name	Address	ID/FEI	Business Operations
Northwind Pharmaceuticals		036986393	repack(51655-100)