Home NDC 78206-191 NDC 78206-191 - Ontruzant 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 78206-191
Package NDCs from labels 78206-191-99
Manufacturer Organon LLC | Samsung Bioepis Co., Ltd.
Effective date 2026-04-20
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 78206-191-99 Ontruzant 1 in 1 VIAL, MULTI-DOSE INJECTION, POWDER, LYOPHILIZED, 1 420 mg 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78206-191 ONTRUZANT (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION ONTRUZANT KIT [ORGANON LLC] 4 Unmatched 20250316_ce2a2492-85e3-4b0a-872a-047f44e4203d.zip