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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-972-052025-01-13C16284748780-11030e365-5a1e-111a-e063-dadaa90a10e2bf6adb75-371d-41c4-83d6-d70d63eea324
55700-972-052024-01-30C16284748780-11030e365-5a1e-111a-e063-dadaa90a10e2bf6adb75-371d-41c4-83d6-d70d63eea324

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-972-05EA - Each55700-972873608dc-e8e6-4972-88f3-2dd3e5b807e212022-09-12

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