FENTANYL

Product NDC
55700-753
11-digit product format
557000753
Labeler code
55700
Product ID
55700-753_447be040-aac5-4a83-b6fb-f28f94f84c40
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
2019-05-17
Marketing end
2025-12-31
Substance
FENTANYL
Active strength
25 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-753-05EA - Each55700-75355950e58-8efc-439b-8403-efc54e26e12d12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-753FENTANYL PATCH, EXTENDED RELEASE [QUALITY CARE PRODUCTS, LLC]6Legacy NDC20230714_3bbc19e3-5bf1-495a-b698-3d77f83236e9.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-753-05557000753055 POUCH in 1 CARTON (55700-753-05) > 1 PATCH in 1 POUCH > 72 h in 1 PATCH5 pouch2019-05-172025-12-31NoNoCurrent