Active ingredient
Iron Sucrose
16 finished FDA listings contain Iron Sucrose as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- IRON SUCROSE
- Dosage forms
- Injection, Injection, Solution
- Routes
- Intravenous, Intravitreal
- Manufacturers / labelers
- 6
- Strengths listed
- 100 mg/5ml · 20 mg/ml · 200 mg/10ml · 50 mg/2.5ml
- Brand names in FDA listings
- Venofer
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 24909
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 021135 | AM REGENT | 2000-11-06 | 7 |
| ANDA 208977 | INTL MEDICATION SYS | 2025-08-08 | 3 |
| ANDA 212340 | SANDOZ | 2025-08-08 | 3 |
| ANDA 212559 | MYLAN LABS LTD | 2025-08-08 | 3 |
Official labeling on DailyMed
- IRON SUCROSE INJECTION, SOLUTION [MYLAN INSTITUTIONAL LLC] · version 2 · 2026-09-07
- IRON SUCROSE INJECTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED] · version 5 · 2026-06-09
- VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 45 · 2026-03-20
- VENOFER (IRON SUCROSE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] · version 12 · 2026-03-20
- VENOFER (IRON SUCROSE) INJECTION, SOLUTION [FRESENIUS MEDICAL CARE HOLDINGS, INC.] · version 29 · 2025-11-17
- IRON SUCROSE INJECTION [SANDOZ INC] · version 1 · 2025-09-23
- VENOFER (IRON SUCROSE) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2024-04-22
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.