Active ingredient
Methoxy Polyethylene Glycol-Epoetin Beta
9 finished FDA listings contain Methoxy Polyethylene Glycol-Epoetin Beta as their only active ingredient.
At a glance
From the FDA NDC Directory
- Ingredient names as written by FDA
- METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 1
- Strengths listed
- 100 ug/.3ml · 120 ug/.3ml · 150 ug/.3ml · 200 ug/.3ml · 250 ug/.3ml · 30 ug/.3ml · 360 ug/.6ml · 50 ug/.3ml · 75 ug/.3ml
- Brand names in FDA listings
- Mircera
Official drug information
Source coverage for Methoxy Polyethylene Glycol-Epoetin Beta:
- FDA NDC Directory: linked
- RxNorm: linked
- Drugs@FDA: linked
- DailyMed: linked
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 729596
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
- Application
- BLA 125164
- Sponsor
- HOFFMAN-LA ROCHE
- Original approval
- 2007-11-14
- Listings
- 9
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| BLA 125164 | HOFFMAN-LA ROCHE | 2007-11-14 | 9 |
Official labeling on DailyMed
- MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) INJECTION, SOLUTION [VIFOR (INTERNATIONAL) INC.] · version 10 · 2026-08-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.