NDC 51759-513 - Simlandi

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
51759-513
Package NDCs from labels
51759-513-21
Manufacturer
Teva Pharmaceuticals USA, Inc.
Effective date
2025-12-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Simlandi - Teva Pharmaceuticals USA, Inc.Teva Pharmaceuticals USA, Inc.2025-12-22HUMAN PRESCRIPTION DRUG LABEL
Simlandi - A-S Medication SolutionsA-S Medication Solutions2025-10-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51759-513-21Simlandi0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL24
51759-513-21Simlandi0.4 mL in 1 SYRINGEINJECTION, SOLUTION0.4 mL40 mg in 0.4mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51759-513SIMLANDI (ADALIMUMAB-RYVK) KIT [TEVA PHARMACEUTICALS USA, INC.]16Unmatched20250313_12f609c9-2088-bb05-e063-6394a90a9ecc.zip
51759-513ADALIMUMAB-RYVK KIT [TEVA PHARMACEUTICALS USA, INC.]1Unmatched20250523_2d19a877-1f5a-4731-800a-dddadc424080.zip