FENTANYL

Product NDC
60505-7081
11-digit product format
605057081
Labeler code
60505
Product ID
60505-7081_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
2025-12-31
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
60505-7081-0EA - Each60505-70818122b3d1-694f-4f39-be26-4106807a183612019-02-13
60505-7081-2EA - Each60505-7081d3e045d6-9223-433d-bf4f-41fedd738cce12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7081FENTANYL 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
60505-7081-2605057081025 POUCH in 1 CARTON (60505-7081-2) > 1 PATCH in 1 POUCH (60505-7081-0) > 72 h in 1 PATCH5 pouch2018-01-100000-00-00NoNoCurrent