Fentanyl

Product NDC
49999-833
11-digit product format
499990833
Labeler code
49999
Product ID
49999-833_2e8cec25-4507-41cf-ae44-aa6c158d5d11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC
Application
ANDA076709
Marketing category
ANDA
Marketing start
2011-12-09
Marketing end
0000-00-00
Substance
FENTANYL
Active strength
8 mg/72h
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49999-833-052025-01-16C16284748780-197449f38-bfbd-f6ea-e053-dbdaa90aa703bac0e494-1925-410f-b9ce-92cf7e9755a3
49999-833-052019-11-13C16284748780-197449f38-bfbd-f6ea-e053-dbdaa90aa703bac0e494-1925-410f-b9ce-92cf7e9755a3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49999-833-05EA - Each49999-83391ca06c0-e1f6-4856-a9dd-2d7505557b4812012-07-24