FENTANYL

Product NDC
60505-7085
11-digit product format
605057085
Labeler code
60505
Product ID
60505-7085_c6f85740-10de-3746-0b5a-27f6c053b242
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Apotex Corp.
Application
ANDA077449
Marketing category
ANDA
Marketing start
2018-01-10
Marketing end
2025-06-30
Substance
FENTANYL
Active strength
38 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
60505-7085-0EA - Each60505-7085eda0ece9-6104-4c1e-94b2-96de0f720afb12018-04-19
60505-7085-2EA - Each60505-7085aac5f622-7287-4794-aed6-66ea641653df12018-04-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7085FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]8Legacy NDC20230502_0ff70df0-2cda-d96c-42a8-3bf180310499.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-7085-2605057085025 POUCH in 1 CARTON (60505-7085-2) > 1 PATCH in 1 POUCH (60505-7085-0) > 72 h in 1 PATCH5 pouch2018-01-100000-00-00NoNoCurrent