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United States · US · US:73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2
SCENESSE
Orange BookUNIISPLATC D02BB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCLINUVEL INC.
CountryUS (United States)
ATC codeD02BB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1173372011611 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASS
Annotations
UNII (FDA Substance ID)
QW68W3J66U
AFAMELANOTIDE
RxCUI 2262250
Orange Book
N210797
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QW68W3J66U",
"rxcui": "2262250",
"inchikey": "UAHFGYDRQSXQEB-LEBBXHLNSA-N",
"display_name": "AFAMELANOTIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"94f53286-11dd-7fbb-e053-2a95a90a7c48": {
"match": "brand_token",
"title": "SCENESSE (AFAMELANOTIDE) IMPLANT [CLINUVEL INC.]",
"spl_version": "11",
"published_date": "2026-05-13"
}
},
"productid": "73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2",
"productndc": "73372-0116",
"dosage_form": "IMPLANT",
"orange_book": {
"appl_no": "210797",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "16MG",
"product_no": "001",
"approval_date": "Oct 8, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "AFAMELANOTIDE",
"proprietary_name": "SCENESSE",
"active_ingred_unit": "mg/16mg",
"application_number": "NDA210797",
"marketing_category": "NDA",
"nonproprietary_name": "afamelanotide",
"start_marketing_date": "20191231",
"active_numerator_strength": "16"
}Related drugs
Other records sharing ATC code D02BB02.
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