Mircera

Product NDC: 0004-0404
11-digit product format: 000040404
Labeler code: 0004
Product ID: 0004-0404_2f92af4c-a3cd-46f7-a171-2a90170955b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Methoxy polyethylene glycol-epoetin beta
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Genentech, Inc.
Application: BLA125164
Marketing category: BLA
Marketing start: 2014-10-24
Marketing end: 2019-07-31
Substance: METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
Active strength: 150 ug/.3mL
Pharmacologic classes: Erythropoiesis-stimulating Agent [EPC],Erythropoietin [CS],Increased Erythroid Cell Production [PE]
NDC exclude flag: No
Listing certified through: 0000-00-00
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	0004-0404		D	Discontinued by firm		2026-07-31
excluded package	package	0004-0404	0004-0404-09	D	Discontinued by firm		2026-07-31

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125164	Mircera	methoxy polyethylene glycol-epoetin beta	351(a)	Rx	2026-06-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
LR3UXN0193	METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA	677324-53-7	METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA