FDA.reportPublic FDA data

FENTANYL

Product NDC
50742-555
11-digit product format
507420555
Labeler code
50742
Product ID
50742-555_4edfd739-fc61-0f08-e063-6394a90ae646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
FENTANYL
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
INGENUS PHARMACEUTICALS, LLC
Application
ANDA077449
Marketing category
ANDA
Marketing start
2025-02-11
Substance
FENTANYL
Active strength
87.5 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
FENTANYL87.5 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
50742-555-01FENTANYL72 h in 1 PATCHPATCH, EXTENDED RELEASE726
50742-555-01FENTANYL1 in 1 POUCHPATCH, EXTENDED RELEASE16
50742-555-05FENTANYL5 in 1 CARTONPATCH, EXTENDED RELEASE56

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-555-01EA - Each50742-55579eded3a-b925-411a-8c20-afb002db1bc112024-11-05
50742-555-05EA - Each50742-555440dded2-5c1c-48b1-a5d0-35cb029bc2a412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-555FENTANYL PATCH, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20250216_bf02ffd0-cc5d-446b-b648-378f6885052f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
245136fentaNYL 100 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
577057fentaNYL 12 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
245134fentaNYL 25 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
245135fentaNYL 50 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
1603498fentaNYL 62.5 MCG/HR 72 HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
197696fentaNYL 75 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
1603501fentaNYL 87.5 MCG/HR 72HR Transdermal SystemPSNbf02ffd0-cc5d-446b-b648-378f6885052f6
57705772 HR fentanyl 0.012 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
24513472 HR fentanyl 0.025 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
160349572 HR fentanyl 0.0375 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
24513572 HR fentanyl 0.05 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
160349872 HR fentanyl 0.0625 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
19769672 HR fentanyl 0.075 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
160350172 HR fentanyl 0.0875 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
24513672 HR fentanyl 0.1 MG/HR Transdermal SystemSCDbf02ffd0-cc5d-446b-b648-378f6885052f6
245136fentanyl 100 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
245136fentanyl 100 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
577057fentanyl 12 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
577057fentanyl 12 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
245134fentanyl 25 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
245134fentanyl 25 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603495fentanyl 37.5 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603495fentaNYL 37.5 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
245135fentanyl 50 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
245135fentanyl 50 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603498fentanyl 62.5 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603498fentanyl 62.5 MCG/HR 72 HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
197696fentanyl 75 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
197696fentanyl 75 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603501fentanyl 87.5 MCG/HR 3 Day Transdermal PatchSYbf02ffd0-cc5d-446b-b648-378f6885052f6
1603501fentanyl 87.5 MCG/HR 72HR Transdermal SystemSYbf02ffd0-cc5d-446b-b648-378f6885052f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50742-555-015074205550172 h in 1 PATCH72 hHistorical
50742-555-05507420555055 POUCH in 1 CARTON (50742-555-05) / 1 PATCH in 1 POUCH (50742-555-01) / 72 h in 1 PATCH5 pouch2025-02-11NoNoCurrent