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United States · US · US:72829-010_4e69249c-b81d-8559-e063-6294a90adbc2
Imcivree
Orange BookUNIISPLATC A08AA12
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRhythm Pharmaceuticals, Inc
CountryUS (United States)
ATC codeA08AA12
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1172829010011 VIAL, MULTI-DOSE in 1 CARTON (72829-010-01) / 1 mL in 1 VIAL, MULTI-DOSE
Annotations
UNII (FDA Substance ID)
N7T15V1FUY
SETMELANOTIDE
RxCUI 2469247
Orange Book
N213793
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "N7T15V1FUY",
"rxcui": "2469247",
"inchikey": "HDHDTKMUACZDAA-PHNIDTBTSA-N",
"display_name": "SETMELANOTIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"70c3ccf7-4df0-4c75-ba07-fede9970c8d9": {
"match": "brand_token",
"title": "IMCIVREE (SETMELANOTIDE) SOLUTION [RHYTHM PHARMACEUTICALS, INC]",
"spl_version": "14",
"published_date": "2026-04-02"
}
},
"productid": "72829-010_4e69249c-b81d-8559-e063-6294a90adbc2",
"productndc": "72829-010",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "213793",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 10MG BASE/ML (EQ 10MG BASE/ML)",
"product_no": "001",
"approval_date": "Nov 25, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "SETMELANOTIDE",
"proprietary_name": "Imcivree",
"active_ingred_unit": "mg/mL",
"application_number": "NDA213793",
"marketing_category": "NDA",
"nonproprietary_name": "setmelanotide",
"start_marketing_date": "20201214",
"active_numerator_strength": "10"
}Related drugs
Other records sharing ATC code A08AA12.
- PLImcivreeRhythm Pharmaceuticals Netherlands B.V.
- FIImcivreeRhythm Pharmaceuticals Netherlands B.V.
- CZIMCIVREERhythm Pharmaceuticals Netherlands B.V., Amsterdam
- CZIMCIVREERhythm Pharmaceuticals Netherlands B.V., Amsterdam
- ISIMCIVREERhythm Pharmaceuticals Netherlands B.V.
- DKIMCIVREERhythm Pharmaceuticals Netherlands B.V.
- CAIMCIVREERHYTHM PHARMACEUTICALS, INC.
- BEImcivree 10 mg/mlRhythm Pharmaceuticals Netherlands
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