Zaleplon (Page 7 of 7)

PRINCIPAL DISPLAY PANEL

Zaleplon 5mg
(click image for full-size original)

ZALEPLON zaleplon capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-189(NDC:29300-131)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZALEPLON (ZALEPLON) ZALEPLON 5 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
SILICON DIOXIDE
SODIUM LAURYL SULFATE
MAGNESIUM STEARATE
LACTOSE MONOHYDRATE
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 1
FD&C RED NO. 40
FERROSOFERRIC OXIDE
FD&C YELLOW NO. 5
Product Characteristics
Color BLUE (Light Blue) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code U;131
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42254-189-60 60 CAPSULE (CAPSULE) in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078989 05/05/2009
Labeler — Rebel Distributors Corp (118802834)
Establishment
Name Address ID/FEI Operations
Rebel Distributors Corp 118802834 RELABEL, REPACK

Revised: 03/2012 Rebel Distributors Corp

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.