vyleesi

Generic: bremelanotide

Labeler: palatin technologies
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vyleesi
Generic Name bremelanotide
Labeler palatin technologies
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

bremelanotide acetate 1.75 mg/.3mL

Manufacturer
Palatin Technologies

Identifiers & Regulatory

Product NDC 80064-141
Product ID 80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210557
Marketing Start 2019-06-21
Marketing End 2026-07-01

Pharmacologic Class

Classes
melanocortin receptor agonist [epc] melanocortin receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80064141
Hyphenated Format 80064-141

Supplemental Identifiers

RxCUI
2176316 2176321
UNII
PV2WI7495P

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vyleesi (source: ndc)
Generic Name bremelanotide (source: ndc)
Application Number NDA210557 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 1.75 mg/.3mL
source: ndc
Packaging
  • 2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01)
  • 4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)
source: ndc

Packages (2)

80064-141-02 2 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01) 80064-141-04 4 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01)

Ingredients (1)

bremelanotide acetate (1.75 mg/.3mL)

Linked Drug Pages (1)

Vyleesi ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "2b5b7036-1413-8c2f-e063-6394a90adf3b", "openfda": {"unii": ["PV2WI7495P"], "rxcui": ["2176316", "2176321"], "spl_set_id": ["8c9607a2-5b57-4a59-b159-cf196deebdd9"], "manufacturer_name": ["Palatin Technologies"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 SYRINGE in 1 CARTON (80064-141-02)  / .3 mL in 1 SYRINGE (80064-141-01)", "package_ndc": "80064-141-02", "marketing_end_date": "20260701", "marketing_start_date": "20190621"}, {"sample": false, "description": "4 SYRINGE in 1 CARTON (80064-141-04)  / .3 mL in 1 SYRINGE (80064-141-01)", "package_ndc": "80064-141-04", "marketing_end_date": "20260701", "marketing_start_date": "20190621"}], "brand_name": "Vyleesi", "product_id": "80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b", "dosage_form": "INJECTION", "pharm_class": ["Melanocortin Receptor Agonist [EPC]", "Melanocortin Receptor Agonists [MoA]"], "product_ndc": "80064-141", "generic_name": "bremelanotide", "labeler_name": "Palatin Technologies", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Vyleesi", "active_ingredients": [{"name": "BREMELANOTIDE ACETATE", "strength": "1.75 mg/.3mL"}], "application_number": "NDA210557", "marketing_category": "NDA", "marketing_end_date": "20260701", "marketing_start_date": "20190621"}