vyleesi

Generic: bremelanotide

Labeler: cosette pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name vyleesi
Generic Name bremelanotide
Labeler cosette pharmaceuticals, inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

bremelanotide acetate 1.75 mg/.3mL

Manufacturer
Cosette Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0713-0897
Product ID 0713-0897_437e6c45-dfb9-35ec-e063-6394a90a7874
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210557
Listing Expiration 2026-12-31
Marketing Start 2025-11-12

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 07130897
Hyphenated Format 0713-0897

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
  • 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06)
source: ndc

Packages (1)

0713-0897-04 4 SYRINGE in 1 CARTON (0713-0897-04) / .3 mL in 1 SYRINGE (0713-0897-06)

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": "437e6c45-dfb9-35ec-e063-6394a90a7874", "openfda": {"unii": ["PV2WI7495P"], "rxcui": ["2176316", "2176321"], "spl_set_id": ["f1d0c1b5-2f39-4bad-a6a4-0066e3ad5dcf"], "manufacturer_name": ["Cosette Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 SYRINGE in 1 CARTON (0713-0897-04)  / .3 mL in 1 SYRINGE (0713-0897-06)", "package_ndc": "0713-0897-04", "marketing_start_date": "20251112"}], "brand_name": "Vyleesi", "product_id": "0713-0897_437e6c45-dfb9-35ec-e063-6394a90a7874", "dosage_form": "INJECTION", "pharm_class": ["Melanocortin Receptor Agonist [EPC]", "Melanocortin Receptor Agonists [MoA]"], "product_ndc": "0713-0897", "generic_name": "bremelanotide", "labeler_name": "Cosette Pharmaceuticals, Inc.", "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_start_date": "20251112", "listing_expiration_date": "20261231"}