FDA.reportPublic FDA data

Vyleesi

Product NDC
80064-141
11-digit product format
800640141
Labeler code
80064
Product ID
80064-141_2b5b7036-1413-8c2f-e063-6394a90adf3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bremelanotide
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Palatin Technologies
Application
NDA210557
Marketing category
NDA
Marketing start
2019-06-21
Marketing end
2026-07-01
Substance
BREMELANOTIDE ACETATE
Active strength
1.75 mg/.3mL
Pharmacologic classes
Melanocortin Receptor Agonist [EPC], Melanocortin Receptor Agonists [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vyleesi

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BREMELANOTIDE ACETATE1.75 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiPV2WI7495P
Rxcui2176316, 2176321

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f1484a13-94d7-4787-a60d-ed588740b0efProduct name120190926

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80064-141-01Vyleesi0.3 mL in 1 SYRINGEINJECTION0.36
80064-141-02Vyleesi2 in 1 CARTONINJECTION26
80064-141-04Vyleesi4 in 1 CARTONINJECTION46

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80064-141-01ML - Milliliter80064-141ef2d099a-d57d-431a-9193-738051c8058712021-07-15
80064-141-04ML - Milliliter80064-141ed67f865-22e5-4769-b8a6-e6cb4a54b7b812021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80064-141VYLEESI (BREMELANOTIDE) INJECTION [PALATIN TECHNOLOGIES]6Current NDC, Legacy NDC, 3 package rows20250112_8c9607a2-5b57-4a59-b159-cf196deebdd9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2176316bremelanotide 1.75 MG in 0.3 mL Auto-InjectorPSN8c9607a2-5b57-4a59-b159-cf196deebdd96
2176321vyleesi 1.75 MG in 0.3 mL Auto-InjectorPSN8c9607a2-5b57-4a59-b159-cf196deebdd96
21763210.3 ML bremelanotide 5.83 MG/ML Auto-Injector [Vyleesi]SBD8c9607a2-5b57-4a59-b159-cf196deebdd96
21763160.3 ML bremelanotide 5.83 MG/ML Auto-InjectorSCD8c9607a2-5b57-4a59-b159-cf196deebdd96
21763210.3 ML Vyleesi 5.83 MG/ML Auto-InjectorSY8c9607a2-5b57-4a59-b159-cf196deebdd96
2176316bremelanotide 1.75 MG (equivalent to bremelanotide acetate 1.89 MG) per 0.3 ML Auto-InjectorSY8c9607a2-5b57-4a59-b159-cf196deebdd96
2176321Vyleesi 1.75 MG (equivalent to bremelanotide acetate 1.89 MG) per 0.3 ML Auto-InjectorSY8c9607a2-5b57-4a59-b159-cf196deebdd96
2176321Vyleesi 1.75 MG per 0.3 ML Auto-InjectorSY8c9607a2-5b57-4a59-b159-cf196deebdd96

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80064-141-01800640141010.3 mL in 1 SYRINGE0.3 mlHistorical
80064-141-02800640141022 SYRINGE in 1 CARTON (80064-141-02) / .3 mL in 1 SYRINGE (80064-141-01) 2 syringe2019-06-212026-07-01NoNoCurrent
80064-141-04800640141044 SYRINGE in 1 CARTON (80064-141-04) / .3 mL in 1 SYRINGE (80064-141-01) 4 syringe2019-06-212026-07-01NoNoCurrent