Fentanyl System

Product NDC
55700-972
11-digit product format
557000972
Labeler code
55700
Product ID
55700-972_22e0f964-22f3-4222-b432-1b41ea03a113
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Quality Care Products, LLC
Application
ANDA202097
Marketing category
ANDA
Marketing start
2022-05-09
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
13 ug/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-972-05557000972051 POUCH in 1 CARTON (55700-972-05) > 5 PATCH in 1 POUCH1 pouch2022-05-090000-00-00NoNoCurrent