FDA.reportPublic FDA data

NDC 47781-427-11 - Fentanyl system

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
47781-427
Requested NDC
47781-427-11
Package NDCs from labels
47781-427-11, 47781-427-47
Manufacturer
ALVOGEN | Kindeva Drug Delivery L.P.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Fentanyl system - ALVOGEN | Kindeva Drug Delivery L.P.ALVOGEN | Kindeva Drug Delivery L.P.2026-03-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47781-427-11Fentanyl system1 in 1 POUCHPATCH127
47781-427-47Fentanyl system5 in 1 CARTONPATCH527

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47781-427FENTANYL SYSTEM (FENTANYL) PATCH [ALVOGEN]24Current NDC, Legacy NDC, 2 package rows20241027_242759ef-cb6d-4e3e-9f8d-5e31efa1f289.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47781-427-11EA - Each47781-4275e3e9365-47dc-4ae4-93b7-6c85f30fb68c12023-07-06
47781-427-47EA - Each47781-42786724d66-f6f8-4a04-ab8a-06f5f899620112016-12-07

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: 245134
unii: UF599785JZ
FENTANYLFENTANYLAveva Drug Delivery Systems Inc.73897c38-e4ec-40bc-9f41-3359ee23a5a82026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 245134
unii: UF599785JZ
FENTANYLFENTANYLINGENUS PHARMACEUTICALS, LLCbf02ffd0-cc5d-446b-b648-378f6885052f2026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 245134
unii: UF599785JZ
Fentanyl systemFENTANYLALVOGEN242759ef-cb6d-4e3e-9f8d-5e31efa1f2892026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA202097
ndc (package): 47781-428-47
ndc (package): 47781-423-47
ndc (package): 47781-424-11
ndc (package): 47781-427-47
ndc (package): 47781-428-11
ndc (package): 47781-426-11
ndc (package): 47781-427-11
ndc (package): 47781-424-47
ndc (package): 47781-423-11
ndc (package): 47781-426-47
ndc (product): 47781-426
ndc (product): 47781-428
ndc (product): 47781-424
ndc (product): 47781-423
ndc (product): 47781-427
ndc11 (package): 47781042711
rxcui: 197696
rxcui: 245136
rxcui: 577057
rxcui: 245135
rxcui: 245134
spl id: 4b8493ea-0ce4-6949-e063-6294a90a8861
spl set id: 242759ef-cb6d-4e3e-9f8d-5e31efa1f289
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: 245134
unii: UF599785JZ

Reported adverse events (FAERS/openFDA)#

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