Mircera

Product NDC

0004-0401

11-digit product format

000040401

Labeler code

0004

Product ID

0004-0401_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

2019-05-31

Substance

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA

Active strength

50 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