FENTANYL

Product NDC
55700-811
11-digit product format
557000811
Labeler code
55700
Product ID
55700-811_bff10128-f732-4126-8265-2f7fdc6b8bfe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Quality Care Products, LLC
Application
ANDA077449
Marketing category
ANDA
Marketing start
2019-10-25
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
75 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-811-05557000811055 POUCH in 1 CARTON (55700-811-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH5 pouch2019-10-250000-00-00NoNoCurrent