Fluoxetine Hydrochloride (Page 8 of 8)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 51655-101-52

MFG: 50111-647-03

Fluoxetine Capsules 10 MG

30 Capsules

Rx Only

Lot#

Exp. Date

Each capsule contains Fluoxetine hydrochloride USP equivalent to 10 mg of fluoxetine.

Dosage: See package insert

Store at 68 to 77 degrees F.

Store in this tight, light-resistant container. Keep out of the reach of children.

Medication guide is found at www.fda.gov/drugs/drugsafety/ucm085729

Mfg by Pliva Krakow Pharmaceutical Co. Krakow, Poland for Teva Pharmaceuticals, Sellersville, PA 18960 Lot#

Repackaged by Northwind Pharmaceticals, Indianapolis, IN 46256

51655-101-52
(click image for full-size original)
FLUOXETINE HYDROCHLORIDE fluoxetine hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:51655-101(NDC:50111-647)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUOXETINE HYDROCHLORIDE (FLUOXETINE) FLUOXETINE 10 mg
Product Characteristics
Color white Score no score
Shape capsule Size 16mm
Flavor Imprint Code PLIVA;647;PLIVA;647
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51655-101-52 30 CAPSULE in 1 BOTTLE, DISPENSING None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076001 11/03/2014
Labeler — Northwind Pharmaceuticals, LLC (036986393)
Registrant — Northwind Pharmaceuticals, LLC (036986393)
Establishment
Name Address ID/FEI Operations
Northwind Pharmaceuticals, LLC 036986393 repack (51655-101)

Revised: 11/2014 Northwind Pharmaceuticals, LLC

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