NDC 71202-003-03 - Eticovo

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: 71202-003
Requested NDC: 71202-003-03
Package NDCs from labels: 71202-003-03, 71202-003-04
Manufacturer: Samsung Bioepis Co., Ltd. | PPD Development Ireland Ltd.
Effective date: 2019-05-07
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Eticovo - Samsung Bioepis Co., Ltd. \| PPD Development Ireland Ltd.	Samsung Bioepis Co., Ltd. \| PPD Development Ireland Ltd.	2019-05-07	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71202-003-04	2021-01-29	C162847	48780-1	ba0f9c33-1cc4-a910-e053-dadaa90a0b85	These highlights do not include all the information needed to use Eticovo safely and effectively. See full prescribing information for Eticovo. Eticovo (etanercept-ykro) injection, for subcutaneous use Initial U.S. Approval: 2019 Eticovo (etanercept-ykro) is biosimilar Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences betwee

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 52 of 52 · 1,021 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lactated Ringers	SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE	Baxter Healthcare Corporation	f09f80bf-2f8b-4420-865d-aec2d5e5cd4d	2012-06-12		Exact identifier unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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