FDA.reportPublic FDA data

Fentanyl system

Product NDC
47781-428
11-digit product format
477810428
Labeler code
47781
Product ID
47781-428_4b8493ea-0ce4-6949-e063-6294a90a8861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fentanyl
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
ALVOGEN
Application
ANDA202097
Marketing category
ANDA
Marketing start
2016-11-04
Substance
FENTANYL
Active strength
100 ug/1
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 system
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FENTANYL100 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUF599785JZ
Rxcui197696, 245134, 245135, 245136, 577057

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
47781-428-11Fentanyl system1 in 1 POUCHPATCH127
47781-428-47Fentanyl system5 in 1 CARTONPATCH527

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-428-11EA - Each47781-428e79c28b2-a69b-4248-86e4-40a2b2ecbffe12018-09-05
47781-428-47EA - Each47781-428810b4c5c-27d2-4912-aca5-81f474284f8312016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-428FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN]24Current NDC, Legacy NDC, 2 package rows20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSN242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCD242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSY242759ef-cb6d-4e3e-9f8d-5e31efa1f28927

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47781-428-11477810428111 in 1 POUCHHistorical
47781-428-47477810428475 POUCH in 1 CARTON (47781-428-47) / 1 PATCH in 1 POUCH (47781-428-11) 5 pouch2016-11-040000-00-00NoNoCurrent