NDC 73372-0116-01 - SCENESSE

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
73372-0116
Requested NDC
73372-0116-01
Package NDCs from labels
73372-0116-1, 73372-0116-01
Manufacturer
CLINUVEL INC.
Effective date
2026-05-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SCENESSE - CLINUVEL INC.CLINUVEL INC.2026-05-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73372-0116-1SCENESSE1 mg in 1 VIAL, GLASSIMPLANT111
73372-0116-1SCENESSE1 in 1 CARTONIMPLANT111

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73372-0116SCENESSE (AFAMELANOTIDE) IMPLANT [CLINUVEL INC.]8Current NDC, Legacy NDC, 2 package rows20240816_94f53286-11dd-7fbb-e053-2a95a90a7c48.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73372-0116-1EA - Each73372-011644a304b2-a2c8-4feb-938c-50b023bd495f12020-04-20

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 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SCENESSEAFAMELANOTIDECLINUVEL INC.94f53286-11dd-7fbb-e053-2a95a90a7c482026-05-11Warnings, Adverse reactionsExact identifier
application number: NDA210797
ndc (package): 73372-0116-1
ndc (product): 73372-0116
ndc11 (package): 73372011601
rxcui: 2262254
rxcui: 2262259
spl id: 5192f26d-d5e7-ce03-e063-6294a90a3ea2
spl set id: 94f53286-11dd-7fbb-e053-2a95a90a7c48
unii: QW68W3J66U

Reported adverse events (FAERS/openFDA)#

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