FDA.reportPublic FDA data

NDC 60505-7008-0 - FENTANYL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60505-7008
Requested NDC
60505-7008-0
Package NDCs from labels
60505-7008-0, 60505-7008-2
Manufacturer
Bryant Ranch Prepack
Effective date
2023-07-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENTANYL - Bryant Ranch PrepackBryant Ranch Prepack2023-07-13HUMAN PRESCRIPTION DRUG LABEL
FENTANYL - Apotex Corp. | Aveva Drug Delivery Systems Inc.Apotex Corp. | Aveva Drug Delivery Systems Inc.2023-07-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-03-03Indexing - Billing Unit

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60505-7008FENTANYL PATCH, EXTENDED RELEASE [APOTEX CORP.]17Legacy NDC20230714_0ff70df0-2cda-d96c-42a8-3bf180310498.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60505-7008-0EA - Each60505-7008ae1f8e2d-d991-4bf7-bf81-c494f840b8db12013-03-03
60505-7008-2EA - Each60505-70080eb1414e-0b56-4f8e-9c68-7a6d28844e0212013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
OCTYLDODECANOLINACTIVE INGREDIENT461N1O614YFENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYBUTENE (1400 MW)INACTIVE INGREDIENT1NA5AO9GH7FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
POLYISOBUTYLENE (800000 MW)INACTIVE INGREDIENTY132ZOQ9H7FENTANYL PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK]1000
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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FENTANYL TRANSDERMALFENTANYL TRANSDERMALSpecGx LLCe15a7e9b-8025-49dd-9a6d-bafcccf1959f2026-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077449
unii: UF599785JZ
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077449
unii: UF599785JZ
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
FENTANYLFENTANYLMylan Pharmaceuticals Inc.2a2238e9-4b5d-c56d-8663-dd354ff9ae0c2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: UF599785JZ
005d170d-692f-f040-e063-6394a90aa0a40ff70df0-2cda-d96c-42a8-3bf1803104982023-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 005d170d-692f-f040-e063-6394a90aa0a4
spl set id: 0ff70df0-2cda-d96c-42a8-3bf180310498
00605cdd-b923-77f2-e063-6394a90a3992578def77-4959-4392-83a8-0abfcbf1d0232023-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 00605cdd-b923-77f2-e063-6394a90a3992
spl set id: 578def77-4959-4392-83a8-0abfcbf1d023

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.