Fentanyl System

Product NDC
55700-973
11-digit product format
557000973
Labeler code
55700
Product ID
55700-973_0aade8f7-8563-4189-86b6-6804445ff89f
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
50 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-973-05EA - Each55700-9731da21f7b-ed07-42ef-a493-c376998af35f12022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-973-05557000973051 POUCH in 1 CARTON (55700-973-05) > 5 PATCH in 1 POUCH1 pouch2022-05-090000-00-00NoNoCurrent