NDC 80064-141-01 - Vyleesi

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 80064-141
Requested NDC: 80064-141-01
Package NDCs from labels: 80064-141-01, 80064-141-04, 80064-141-02
Manufacturer: Palatin Technologies | Catalent | Lonza | PCI
Effective date: 2025-01-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Vyleesi - Palatin Technologies \| Catalent \| Lonza \| PCI	Palatin Technologies \| Catalent \| Lonza \| PCI	2025-01-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80064-141-01	Vyleesi	0.3 mL in 1 SYRINGE	INJECTION	0.3	6
80064-141-02	Vyleesi	2 in 1 CARTON	INJECTION	2	6
80064-141-04	Vyleesi	4 in 1 CARTON	INJECTION	4	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80064-141	VYLEESI (BREMELANOTIDE) INJECTION [PALATIN TECHNOLOGIES]	6	Legacy NDC, 3 package rows	20250112_8c9607a2-5b57-4a59-b159-cf196deebdd9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80064-141-01	ML - Milliliter	80064-141	ef2d099a-d57d-431a-9193-738051c80587	1	2021-07-15
80064-141-04	ML - Milliliter	80064-141	ed67f865-22e5-4769-b8a6-e6cb4a54b7b8	1	2021-07-15

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 25 · 482 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eye Wash	WATER	CVS Pharmacy	049cee29-7ec2-4d5b-8308-f522acde43a7	2017-03-29	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Baxter Healthcare Company	210dc9ab-d6ca-4552-ac19-1be17792d290	2016-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.