NDC 55513-522 - 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: 55513-522
Package NDCs from labels: 55513-522-14
Manufacturer: Amgen, Inc | Celgene International Sarl
Effective date: 2026-09-02
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Otezla - Amgen, Inc \| Celgene International Sarl	Amgen, Inc \| Celgene International Sarl	2026-09-02	HUMAN PRESCRIPTION DRUG LABEL

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 169 of 169 · 3,361 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD.	30468afc-9616-4765-b046-12e97a0a7827	2010-12-20	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.