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United States · US · US:80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b
Vyleesi
Orange BookUNIISPLATC G02CX05
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerPalatin Technologies
CountryUS (United States)
ATC codeG02CX05
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 2
- ndc1180064141022 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01)
- ndc1180064141044 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)
Annotations
UNII (FDA Substance ID)
PV2WI7495P
BREMELANOTIDE ACETATE
RxCUI 2176311
Orange Book
N210557
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "PV2WI7495P",
"rxcui": "2176311",
"inchikey": "MAYUSRUHXFWITM-GBRHMYBBSA-N",
"display_name": "BREMELANOTIDE ACETATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "SUBCUTANEOUS",
"spl_meta": {
"f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf": {
"match": "brand_token",
"title": "VYLEESI (BREMELANOTIDE) INJECTION [COSETTE PHARMACEUTICALS, INC.]",
"spl_version": "1",
"published_date": "2025-11-18"
}
},
"productid": "80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b",
"productndc": "80064-141",
"dosage_form": "INJECTION",
"orange_book": {
"appl_no": "210557",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)",
"product_no": "001",
"approval_date": "Jun 21, 2019"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BREMELANOTIDE ACETATE",
"proprietary_name": "Vyleesi",
"active_ingred_unit": "mg/.3mL",
"application_number": "NDA210557",
"marketing_category": "NDA",
"nonproprietary_name": "bremelanotide",
"start_marketing_date": "20190621",
"active_numerator_strength": "1.75"
}Related drugs
Other records sharing ATC code G02CX05.
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