Home NDC 3215-7703-01 NDC 3215-7703-01 - 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 3215-7703
Requested NDC 3215-7703-01
Package NDCs from labels 3215-7703-01, 3215-7703-05
Manufacturer Aveva Drug Delivery Systems Inc. | DifGen Pharmaceuticals LLC
Effective date 2026-04-07
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 3215-7703-01 FENTANYL 1 in 1 POUCH PATCH, EXTENDED RELEASE 1 2 3215-7703-01 FENTANYL 72 h in 1 PATCH PATCH, EXTENDED RELEASE 72 2 3215-7703-05 FENTANYL 5 in 1 CARTON PATCH, EXTENDED RELEASE 5 2
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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join FENTANYL TRANSDERMAL FENTANYL TRANSDERMAL SpecGx LLC e15a7e9b-8025-49dd-9a6d-bafcccf1959f 2026-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 197696 rxcui: 245136 rxcui: 577057 rxcui: 245135 rxcui: 1603498 rxcui: 245134 rxcui: 1603495 unii: UF599785JZ FENTANYL FENTANYL Aveva Drug Delivery Systems Inc. 73897c38-e4ec-40bc-9f41-3359ee23a5a8 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application number: ANDA077449 ndc (package): 3215-7706-01 ndc (package): 3215-7706-05 ndc (package): 3215-7705-01 ndc (package): 3215-7702-05 ndc (package): 3215-7704-01 ndc (package): 3215-7708-05 ndc (package): 3215-7707-05 ndc (package): 3215-7705-05 ndc (package): 3215-7703-01 ndc (package): 3215-7703-05 ndc (package): 3215-7701-05 ndc (package): 3215-7708-01 ndc (package): 3215-7707-01 ndc (package): 3215-7701-01 ndc (package): 3215-7702-01 ndc (package): 3215-7704-05 ndc (product): 3215-7708 ndc (product): 3215-7705 ndc (product): 3215-7706 ndc (product): 3215-7701 ndc (product): 3215-7704 ndc (product): 3215-7707 ndc (product): 3215-7702 ndc (product): 3215-7703 ndc11 (package): 03215770301 rxcui: 197696 rxcui: 245136 rxcui: 577057 rxcui: 245135 rxcui: 1603498 rxcui: 245134 rxcui: 1603495 rxcui: 1603501 spl id: 4edfc77d-dee4-611b-e063-6294a90a47f8 spl set id: 73897c38-e4ec-40bc-9f41-3359ee23a5a8 unii: UF599785JZ FENTANYL FENTANYL INGENUS PHARMACEUTICALS, LLC bf02ffd0-cc5d-446b-b648-378f6885052f 2026-04-07 Boxed warning, Warnings, Adverse reactions Exact identifier application number: ANDA077449 rxcui: 197696 rxcui: 245136 rxcui: 577057 rxcui: 245135 rxcui: 1603498 rxcui: 245134 rxcui: 1603495 rxcui: 1603501 unii: UF599785JZ Fentanyl system FENTANYL ALVOGEN 242759ef-cb6d-4e3e-9f8d-5e31efa1f289 2026-03-02 Boxed warning, Warnings, Adverse reactions Exact identifier rxcui: 197696 rxcui: 245136 rxcui: 577057 rxcui: 245135 rxcui: 245134 unii: UF599785JZ FENTANYL FENTANYL Mylan Pharmaceuticals Inc. 2a2238e9-4b5d-c56d-8663-dd354ff9ae0c 2025-12-15 Boxed warning, Warnings, Adverse reactions Exact 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.