FDA.reportPublic FDA data

NDC 70121-2538 - 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
70121-2538
Package NDCs from labels
70121-2538-9
Manufacturer
Amneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited
Effective date
2025-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leuprolide Acetate Injection [14 mg/2.8 mL (1 mg/0.2 mL)] Rx onlyAmneal Pharmaceuticals LLC | Amneal Pharmaceuticals of New York, LLC | Amneal Pharmaceuticals Private Limited2025-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-2538-9leuprolide acetate1 mL in 1 PACKETSWAB28 mL0.7 mL in 1mL9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-2538LEUPROLIDE ACETATE KIT [AMNEAL PHARMACEUTICALS LLC]7Unmatched20250427_4838c674-044e-46b2-81e7-c691b99d8fa5.zip