FDA.reportPublic FDA data

NDC 55513-069 - IMDELLTRA (AMG757)

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
55513-069
Package NDCs from labels
55513-069-01
Manufacturer
Amgen, Inc | Immunex Rhode Island Corporation
Effective date
2025-11-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IMDELLTRA (AMG757) - Amgen, Inc | Immunex Rhode Island CorporationAmgen, Inc | Immunex Rhode Island Corporation2025-11-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-069-01IMDELLTRA (AMG757)10 mg in 1 VIALINJECTION, POWDER, LYOPHILIZED,10 mg2.4 mg in 1mg5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-069IMDELLTRA (AMG757) (TARLATAMAB-DLLE) KIT [AMGEN INC]3Unmatched20240718_1e7b6163-5d83-42ea-82c9-cf7620cdc782.zip