NDC 55513-518 - Otezla

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
55513-518
Package NDCs from labels
55513-518-04
Manufacturer
Amgen, Inc | Celgene International Sarl
Effective date
2025-12-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Otezla - Amgen, Inc | Celgene International SarlAmgen, Inc | Celgene International Sarl2025-12-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-518-04Otezla4 in 1 BLISTER PACKTABLET, FILM COATED410 mg34
55513-518-04Otezla4 in 1 BLISTER PACKTABLET, FILM COATED410 mg34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-518OTEZLA (APREMILAST) TABLET, FILM COATED OTEZLA (APREMILAST) KIT [AMGEN INC]28Unmatched20240509_f6b1f516-4972-4d82-bced-113e47b41cc5.zip