FDA Orange Book
Generic for Zinecard
Zinecard contains dexrazoxane. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Zinecard is dexrazoxane. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
Run it in Rivvi
Map Zinecard and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Zinecard products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 250MG BASE/VIAL | Discontinued | None | 4 | AP |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 4 | AP |
NDA 020212, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dexrazoxane
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 076068 | AP (A-rated, therapeutically equivalent) | September 28, 2004 | EQ 250MG BASE/VIAL, EQ 500MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 200752 | AP (A-rated, therapeutically equivalent) | October 19, 2011 | EQ 250MG BASE/VIAL, EQ 500MG BASE/VIAL |
| GLAND PHARMA LTD | 207321 | AP (A-rated, therapeutically equivalent) | December 16, 2019 | EQ 250MG BASE/VIAL, EQ 500MG BASE/VIAL |
| MSN LABORATORIES PRIVATE LTD | 216748 | AP (A-rated, therapeutically equivalent) | March 26, 2025 | EQ 250MG BASE/VIAL, EQ 500MG BASE/VIAL |
Questions
Is there a generic for Zinecard?
Yes. The generic name for Zinecard is dexrazoxane. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Zinecard?
The active ingredient in Zinecard is dexrazoxane, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.