FENTANYL

Manufacturer
Mylan Technologies Inc.
Effective date
2019-01-22
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:34:44

Label at a glance#

ProductFENTANYL
Active ingredientFENTANYL
Label structure5 sections

Label contents#

Full prescribing information#

PRINCIPAL DISPLAY PANEL – 12 microgram/hour

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

12 microgram/hour Carton Label - UK
12 microgram/hour Carton Label - UK
12 microgram/hour Carton Label - Belgium
12 microgram/hour Carton Label - Belgium
12 microgram/hour Carton Label - Sweden
12 microgram/hour Carton Label - Sweden
12 microgram/hour Carton Label - Czech
12 microgram/hour Carton Label - Czech
12 microgram/hour Carton Label - Greece
12 microgram/hour Carton Label - Greece
12 microgram/hour Carton Label - Denmark
12 microgram/hour Carton Label - Denmark
12 microgram/hour Carton Label - Netherlands
12 microgram/hour Carton Label - Netherlands
12 microgram/hour Carton Label - France
12 microgram/hour Carton Label - France
12 microgram/hour Carton Label - Portugal
12 microgram/hour Carton Label - Portugal

PRINCIPAL DISPLAY PANEL – 25 microgram/hour

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 microgram/hour Carton Label - UK
25 microgram/hour Carton Label - UK
25 microgram/hour Carton Label - Belgium
25 microgram/hour Carton Label - Belgium
25 microgram/hour Carton Label - Germany
25 microgram/hour Carton Label - Germany
25 microgram/hour Carton Label - Sweden
25 microgram/hour Carton Label - Sweden
25 microgram/hour Carton Label - Czech
25 microgram/hour Carton Label - Czech
25 microgram/hour Carton Label - Greece
25 microgram/hour Carton Label - Greece
25 microgram/hour Carton Label - Denmark
25 microgram/hour Carton Label - Denmark
25 microgram/hour Carton Label - Netherlands
25 microgram/hour Carton Label - Netherlands
25 microgram/hour Carton Label - France
25 microgram/hour Carton Label - France
25 microgram/hour Carton Label - Portugal
25 microgram/hour Carton Label - Portugal
25 microgram/hour Carton Label - Spain
25 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 50 microgram/hour

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

50 microgram/hour Carton Label - UK
50 microgram/hour Carton Label - UK
50 microgram/hour Carton Label - Belgium
50 microgram/hour Carton Label - Belgium
50 microgram/hour Carton Label - Germany
50 microgram/hour Carton Label - Germany
50 microgram/hour Carton Label - Sweden
50 microgram/hour Carton Label - Sweden
50 microgram/hour Carton Label - Czech
50 microgram/hour Carton Label - Czech
50 microgram/hour Carton Label - Greece
50 microgram/hour Carton Label - Greece
50 microgram/hour Carton Label - Denmark
50 microgram/hour Carton Label - Denmark
50 microgram/hour Carton Label - Netherlands
50 microgram/hour Carton Label - Netherlands
50 microgram/hour Carton Label - France
50 microgram/hour Carton Label - France
50 microgram/hour Carton Label - Portugal
50 microgram/hour Carton Label - Portugal
50 microgram/hour Carton Label - Spain
50 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 75 microgram/hour

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75 microgram/hour Carton Label - UK
75 microgram/hour Carton Label - UK
75 microgram/hour Carton Label - Belgium
75 microgram/hour Carton Label - Belgium
75 microgram/hour Carton Label - Germany
75 microgram/hour Carton Label - Germany
75 microgram/hour Carton Label - Sweden
75 microgram/hour Carton Label - Sweden
75 microgram/hour Carton Label - Czech
75 microgram/hour Carton Label - Czech
75 microgram/hour Carton Label - Greece
75 microgram/hour Carton Label - Greece
75 microgram/hour Carton Label - Denmark
75 microgram/hour Carton Label - Denmark
75 microgram/hour Carton Label - Netherlands
75 microgram/hour Carton Label - Netherlands
75 microgram/hour Carton Label - France
75 microgram/hour Carton Label - France
75 microgram/hour Carton Label - Portugal
75 microgram/hour Carton Label - Portugal
75 microgram/hour Carton Label - Spain
75 microgram/hour Carton Label - Spain

PRINCIPAL DISPLAY PANEL – 100 microgram/hour

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100 microgram/hour Carton Label - UK
100 microgram/hour Carton Label - UK
100 microgram/hour Carton Label - Belgium
100 microgram/hour Carton Label - Belgium
100 microgram/hour Carton Label - Germany
100 microgram/hour Carton Label - Germany
100 microgram/hour Carton Label - Sweden
100 microgram/hour Carton Label - Sweden
100 microgram/hour Carton Label - Czech
100 microgram/hour Carton Label - Czech
100 microgram/hour Carton Label - Greece
100 microgram/hour Carton Label - Greece
100 microgram/hour Carton Label - Denmark
100 microgram/hour Carton Label - Denmark
100 microgram/hour Carton Label - Netherlands
100 microgram/hour Carton Label - Netherlands
100 microgram/hour Carton Label - France
100 microgram/hour Carton Label - France
100 microgram/hour Carton Label - Portugal
100 microgram/hour Carton Label - Portugal
100 microgram/hour Carton Label - Spain
100 microgram/hour Carton Label - Spain

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSN3
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSN3
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSN3
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSN3
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSN3
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCD3
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCD3
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCD3
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCD3
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCD3
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSY3
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSY3
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSY3
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSY3
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSY3
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSY3
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSY3
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSY3
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSY3
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
FENTANYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77d14d2b-b9bf-4254-8dd6-c60dedb281d3Product name120231002
a8df478d-5b88-9654-981b-87dff14dda8bProduct name220190801
e9b48db2-e05b-8c2d-e4ac-a5a2efb26b57Product name220180118
bb365072-425e-ca0a-021e-fd8b78162502Product name220161228
339915c8-cc8f-ceb4-1d3f-5ea267d21ea6Product name220160104
739fa0ac-b690-63c4-9904-e20dffbf78f9Product name120140508
7763fcbb-367d-ed06-b37f-e1529b6241beProduct name120140508
d9ff6610-5d2e-d5c8-8a19-867d4a1efb77Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59490-4190-9FENTANYL5 in 1 CARTONPATCH53
59490-4190-9FENTANYL1 in 1 POUCHPATCH13
59490-4191-9FENTANYL1 in 1 POUCHPATCH13
59490-4191-9FENTANYL5 in 1 CARTONPATCH53
59490-4192-9FENTANYL5 in 1 CARTONPATCH53
59490-4192-9FENTANYL1 in 1 POUCHPATCH13
59490-4193-9FENTANYL1 in 1 POUCHPATCH13
59490-4193-9FENTANYL5 in 1 CARTONPATCH53
59490-4194-9FENTANYL1 in 1 POUCHPATCH13
59490-4194-9FENTANYL5 in 1 CARTONPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59490-4190FENTANYL PATCH [MYLAN TECHNOLOGIES INC.]32 package rows20210113_eec9848f-56b0-428c-becd-4f9c7100faed.zip
59490-4191FENTANYL PATCH [MYLAN TECHNOLOGIES INC.]32 package rows20210113_eec9848f-56b0-428c-becd-4f9c7100faed.zip
59490-4192FENTANYL PATCH [MYLAN TECHNOLOGIES INC.]32 package rows20210113_eec9848f-56b0-428c-becd-4f9c7100faed.zip
59490-4193FENTANYL PATCH [MYLAN TECHNOLOGIES INC.]32 package rows20210113_eec9848f-56b0-428c-becd-4f9c7100faed.zip
59490-4194FENTANYL PATCH [MYLAN TECHNOLOGIES INC.]32 package rows20210113_eec9848f-56b0-428c-becd-4f9c7100faed.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 1 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f5256dd5-2c66-42dd-a423-a9cd5eb24d14eec9848f-56b0-428c-becd-4f9c7100faed2019-01-22Exact identifier
spl id: f5256dd5-2c66-42dd-a423-a9cd5eb24d14
spl set id: eec9848f-56b0-428c-becd-4f9c7100faed

Reported adverse events (FAERS/openFDA)#

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