Active ingredient
Dexrazoxane
10 finished FDA listings contain Dexrazoxane as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DEXRAZOXANE, DEXRAZOXANE HYDROCHLORIDE
- Dosage forms
- Injection, Powder, Lyophilized, For Solution
- Routes
- Intravenous
- Manufacturers / labelers
- 5
- Strengths listed
- 250 mg/1 · 250 mg/25ml · 500 mg/1 · 500 mg/50ml
- Brand names in FDA listings
- Dexrazoxane
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42736
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 |
|---|---|---|---|
| ANDA 076068 | HIKMA | 2004-09-28 | 2 |
| ANDA 207321 | GLAND | 2016-11-28 | 6 |
| ANDA 216748 | MSN | 2025-03-26 | 2 |
Official labeling on DailyMed
- DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.] · version 5 · 2026-08-07
- DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ALMAJECT, INC.] · version 7 · 2026-08-07
- DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC.] · version 8 · 2025-09-29
- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2025-08-11
- DEXRAZOXANE (DEXRAZOXANE FOR INJECTION) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GLAND PHARMA LIMITED] · version 6 · 2025-06-25
- DEXRAZOXANE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.] · version 8 · 2025-01-27
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.