FDA.reportPublic FDA data

NDC 60505-7085-0 - 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
60505-7085
Requested NDC
60505-7085-0
Package NDCs from labels
60505-7085-0, 60505-7085-2
Manufacturer
Apotex Corp.
Effective date
2023-05-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENTANYL - Apotex Corp.Apotex Corp.2023-05-01HUMAN PRESCRIPTION DRUG LABEL

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

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

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 6 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
6319f139-d677-f101-0a24-28aa1c03f3160ff70df0-2cda-d96c-42a8-3bf1803104992023-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 6319f139-d677-f101-0a24-28aa1c03f316
spl set id: 0ff70df0-2cda-d96c-42a8-3bf180310499

Reported adverse events (FAERS/openFDA)#

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