Active ingredient
Ferric Carboxymaltose
7 finished FDA listings contain Ferric Carboxymaltose as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- FERRIC CARBOXYMALTOSE
- Dosage forms
- Injection, Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 3
- Strengths listed
- 50 mg/ml
- Brand names in FDA listings
- Ferric Carboxymaltose, Injectafer
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1433693
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 | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 203565 | AM REGENT | 2013-07-25 | 4 |
| ANDA 212572 | MYLAN LABS LTD | 2026-06-25 | 1 |
| ANDA 217076 | MYLAN | 2026-06-25 | 1 |
| ANDA 217769 | MYLAN | 2026-06-25 | 1 |
Official labeling on DailyMed
- FERRIC CARBOXYMALTOSE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 3 · 2026-09-10
- FERRIC CARBOXYMALTOSE (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION [SANDOZ, INC.] · version 2 · 2026-09-04
- FERRIC CARBOXYMALTOSE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 5 · 2026-09-03
- FERRIC CARBOXYMALTOSE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 3 · 2026-09-02
- INJECTAFER (FERRIC CARBOXYMALTOSE INJECTION) INJECTION, SOLUTION INJECTAFER (FERRIC CARBOXYMALTOSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 30 · 2026-08-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.