Eticovo

Product NDC: 71202-004
11-digit product format: 712020004
Labeler code: 71202
Product ID: 71202-004_d2d6f14e-fdc3-46ab-b84b-4b17d3bea8f0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etanercept
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Samsung Bioepis Co., Ltd.
Application: BLA761066
Marketing category: BLA
Marketing start: 2020-10-31
Marketing end: 0000-00-00
Substance: ETANERCEPT
Active strength: 25 mg/.5mL
Pharmacologic classes: Tumor Necrosis Factor Blocker [EPC],Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	71202-004		D	Discontinued by firm		2026-07-31
excluded package	package	71202-004	71202-004-04	D	Discontinued by firm		2026-07-31

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71202-004-04	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

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761066	Eticovo	etanercept-ykro	351(k) Interchangeable	Disc	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
OP401G7OJC	ETANERCEPT	185243-69-0	ETANERCEPT

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Eticovo	Samsung Bioepis Co., Ltd. \| PPD Development Ireland Ltd.	2019-05-07	HUMAN PRESCRIPTION DRUG LABEL	1