FDA.reportPublic FDA data

NDC 71288-350 - 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
71288-350
Package NDCs from labels
71288-350-91
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
71288-350-91Leuprolide Acetate0.5 mL in 1 PACKETSWAB14 mL0.35 mL in 0.5mL2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-350LEUPROLIDE ACETATE KIT [MEITHEAL PHARMACEUTICALS INC]1Unmatched20240515_d6bd26bd-b8d8-4c5a-bc5c-7b8a1efaa584.zip