NDC 50742-551-01 - 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
50742-551
Requested NDC
50742-551-01
Package NDCs from labels
50742-551-01, 50742-551-05
Manufacturer
INGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc.
Effective date
2026-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
FENTANYLINGENUS PHARMACEUTICALS, LLC | DifGen Pharmaceuticals LLC | Aveva Drug Delivery Systems Inc.2026-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50742-551-01FENTANYL1 in 1 POUCHPATCH, EXTENDED RELEASE16
50742-551-01FENTANYL72 h in 1 PATCHPATCH, EXTENDED RELEASE726
50742-551-05FENTANYL5 in 1 CARTONPATCH, EXTENDED RELEASE56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-551FENTANYL PATCH, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]4Current NDC, 3 package rows20250216_bf02ffd0-cc5d-446b-b648-378f6885052f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-551-01EA - Each50742-551806d2e19-f73e-4d46-a8b0-da2b4089428a12024-11-05
50742-551-05EA - Each50742-551e8b3f45d-231e-40a1-9f03-bbf0f01c8e0812024-11-05

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 5 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
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 1603498
rxcui: 245134
rxcui: 1603495
unii: UF599785JZ
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077449
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 1603498
rxcui: 245134
rxcui: 1603495
rxcui: 1603501
unii: UF599785JZ
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA077449
ndc (package): 50742-551-01
ndc (package): 50742-549-05
ndc (package): 50742-555-01
ndc (package): 50742-553-05
ndc (package): 50742-556-05
ndc (package): 50742-556-01
ndc (package): 50742-555-05
ndc (package): 50742-551-05
ndc (package): 50742-552-05
ndc (package): 50742-553-01
ndc (package): 50742-552-01
ndc (package): 50742-550-01
ndc (package): 50742-549-01
ndc (package): 50742-554-01
ndc (package): 50742-554-05
ndc (package): 50742-550-05
ndc (product): 50742-551
ndc (product): 50742-556
ndc (product): 50742-555
ndc (product): 50742-549
ndc (product): 50742-554
ndc (product): 50742-552
ndc (product): 50742-550
ndc (product): 50742-553
ndc11 (package): 50742055101
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 1603498
rxcui: 245134
rxcui: 1603495
rxcui: 1603501
spl id: 4edfd739-fc61-0f08-e063-6394a90ae646
spl set id: bf02ffd0-cc5d-446b-b648-378f6885052f
unii: UF599785JZ
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 245134
unii: UF599785JZ
FENTANYLFENTANYLMylan Pharmaceuticals Inc.2a2238e9-4b5d-c56d-8663-dd354ff9ae0c2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 1603498
rxcui: 245134
rxcui: 1603495
rxcui: 1603501
unii: UF599785JZ

Reported adverse events (FAERS/openFDA)#

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