ZALEPLON (Page 5 of 5)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ZALEPLON CAPSULES 10 mg — Container Label

NDC 67877-211-01

ZALEPLONCIV

CAPSULES

10 mg

Pharmacist:

Dispense with Medication Guide

Rx Only

100 Capsules

Zaleplon Capsule 10 mg -- Container Label
(click image for full-size original)
Zaleplon Capsule 10 mg — Container Label
ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52959-957(NDC:67877-211)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZALEPLON (ZALEPLON) ZALEPLON 10 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE, COLLOIDAL
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
LACTOSE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERRIC OXIDE BLACK
Product Characteristics
Color BLUE (Dark Blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code ASC;211
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52959-957-30 30 CAPSULE (100 CAPSULE) in 1 BOTTLE None
2 NDC:52959-957-60 60 CAPSULE (CAPSULE) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078989 12/15/2010
Labeler — H.J. Harkins Company, Inc. (147681894)
Registrant — Ascend Laboratories, LLC (141250469)
Establishment
Name Address ID/FEI Operations
Unichem Laboratories Limited 915389741 MANUFACTURE

Revised: 08/2011 H.J. Harkins Company, Inc.

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