FDA.reportPublic FDA data

Mircera

Product NDC
0004-0403
11-digit product format
000040403
Labeler code
0004
Product ID
0004-0403_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
100 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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0004-0403DDiscontinued by firm2026-07-31
excluded packagepackage0004-04030004-0403-09DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0004-0403-09ML - Milliliter0004-04032c818087-325d-4061-8362-588bfceea12512015-01-05

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
125164Mirceramethoxy polyethylene glycol-epoetin beta351(a)Rx2026-06-01