Home NDC 0121-1053 NDC 0121-1053 - 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 0121-1053
Package NDCs from labels 0121-1053-02
Manufacturer PAI Holdings, LLC dba PAI Pharma
Effective date 2026-01-16
Current FDA listing Not matched in FDA.report NDC product tables DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0121-1053-02 leuprolide acetate 2.8 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2.8 mL 5 mg in 1mL 4 0121-1053-02 leuprolide acetate 1 in 1 CARTON INJECTION, SOLUTION 5 mg in 1mL 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0121-1053 LEUPROLIDE ACETATE KIT [PAI HOLDINGS, LLC DBA PAI PHARMA] 3 Unmatched 20250201_19be0b7f-e68a-4547-9e49-b51b12821907.zip