FENTANYL

Product NDC
60505-7009
11-digit product format
605057009
Labeler code
60505
Product ID
60505-7009_3667df05-f059-309d-c2e7-1b1be5c9388e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Apotex Corp.
Application
ANDA077449
Marketing category
ANDA
Marketing start
2013-04-04
Marketing end
2026-01-31
Substance
FENTANYL
Active strength
100 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
60505-7009-0EA - Each60505-7009ceedb038-c5d9-4c96-bb68-61d29d0e6c2912013-03-03
60505-7009-2EA - Each60505-700985c09eb5-1da5-4291-b4df-b546888ec17e12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5
POLYISOBUTYLENE (800000 MW)INACTIVE INGREDIENTY132ZOQ9H7FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7009FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]17Legacy NDC20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60505-7009-2605057009025 POUCH in 1 CARTON (60505-7009-2) > 1 PATCH in 1 POUCH (60505-7009-0) > 72 h in 1 PATCH5 pouch2013-04-040000-00-00NoNoCurrent