Fentanyl (Page 12 of 12)

PRINCIPAL DISPLAY PANEL

NDC 68258-3040-01------ALZA
(click image for full-size original)

NDC 68258-3040-01——ALZA

12 mcg/h
Five (12 mcg/h) Systems
Fentanyl Transdermal System
12 mcg/h
CII
In vivo delivery of 12 mcg/h fentanyl for 72 hours
Because it can cause trouble breathing which can be fatal,
DO NOT USE fentanyl Transdermal System:
* For short term or any post-operative pain, or occasional pain
* For mild pain or pain that can be treated with non-opioid or as-needed opioid medication
* Unless you have been using other narcotic opioid medicines (must be opioid tolerant)
Each transdermal system contains: 2.1 mg fentanyl

DO NOT USE IF SEAL ON POUCH IS BROKEN
KEEP OUT OF REACH OF CHILDREN
Read enclosed Fentanyl Transdermal System
Medication Guide for important safety information.
Rx only
SANDOZ
ONLYfor pain requiring opioid medicine around-the-clock

FENTANYL fentanyl patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68258-3040(NDC:0781-7240)
Route of Administration TRANSDERMAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Fentanyl (Fentanyl) Fentanyl 12 ug
Inactive Ingredients
Ingredient Name Strength
copovidone
Product Characteristics
Color white (Clear, translucent) Score no score
Shape SQUARE Size 53mm
Flavor Imprint Code none
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68258-3040-1 5 POUCH (POUCH) in 1 BOX contains a POUCH
1 1 PATCH (PATCH) in 1 POUCH This package is contained within the BOX (68258-3040-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019813 10/01/2004
Labeler — Dispensing Solutions, Inc. (066070785)
Establishment
Name Address ID/FEI Operations
Dispensing Solutions, Inc. 066070785 relabel, repack

Revised: 09/2011 Dispensing Solutions, Inc.

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 © 2023. All Rights Reserved.