FDA.reportPublic FDA data

NDC 71288-565 - Leuprolide Acetate

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
71288-565
Package NDCs from labels
71288-565-03
Manufacturer
Meitheal Pharmaceuticals Inc
Effective date
2025-06-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate - Meitheal Pharmaceuticals IncMeitheal Pharmaceuticals Inc2025-06-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-565-03Leuprolide Acetate2.8 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION2.8 mL5 mg in 1mL2
71288-565-03Leuprolide Acetate1 in 1 CARTONINJECTION, SOLUTION5 mg in 1mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-565LEUPROLIDE ACETATE KIT [MEITHEAL PHARMACEUTICALS INC]1Unmatched20240515_d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584.zip