FDA.reportPublic FDA data

FENTANYL

Product NDC
0378-9126
11-digit product format
003789126
Labeler code
0378
Product ID
0378-9126_a6e21c86-57e5-4be5-b1bb-c894893991b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA076258
Marketing category
ANDA
Marketing start
2015-02-26
Substance
FENTANYL
Active strength
62.5 ug/h
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FENTANYL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL62.5 ug/h

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUF599785JZ
Rxcui197696, 245134, 245135, 245136, 577057, 1603495, 1603498, 1603501

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
0378-9126-16FENTANYL1 in 1 POUCHPATCH127
0378-9126-16FENTANYL72 h in 1 PATCHPATCH7227
0378-9126-98FENTANYL5 in 1 CARTONPATCH527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-9126-16EA - Each0378-9126f8e249df-3a7b-4c95-a4e9-285c3d26019012018-05-09
0378-9126-98EA - Each0378-912677b318cc-4cff-42b0-b947-f69228aacb4512015-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
FENTANYLACTIVE INGREDIENTUF599785JZFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
FENTANYLACTIVE MOIETYUF599785JZFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9
TRIMETHYLSILYL TREATED DIMETHICONOL/TRIMETHYLSILOXYSILICATE CROSSPOLYMER (40/60 W/W)INACTIVE INGREDIENT9N5G1G3D3HFENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-9126FENTANYL PATCH [MYLAN PHARMACEUTICALS INC.]23Current NDC, Legacy NDC, 3 package rows20241019_2a2238e9-4b5d-c56d-8663-dd354ff9ae0c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603498fentaNYL 62.5 MCG/HR 72 HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603501fentaNYL 87.5 MCG/HR 72HR Transdermal SystemPSN2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
160349572 HR fentanyl 0.0375 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
160349872 HR fentanyl 0.0625 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
160350172 HR fentanyl 0.0875 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCD2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603495fentanyl 37.5 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603498fentanyl 62.5 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603498fentanyl 62.5 MCG/HR 72 HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603501fentanyl 87.5 MCG/HR 3 Day Transdermal PatchSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27
1603501fentanyl 87.5 MCG/HR 72HR Transdermal SystemSY2a2238e9-4b5d-c56d-8663-dd354ff9ae0c27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-9126-16003789126161 in 1 POUCHHistorical
0378-9126-98003789126985 POUCH in 1 CARTON (0378-9126-98) / 1 PATCH in 1 POUCH (0378-9126-16) / 72 h in 1 PATCH5 pouch2015-02-260000-00-00NoNoCurrent