FDA Orange Book
Generic for Totect
Totect 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 Totect is dexrazoxane. 4 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Totect products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 4 | AP |
NDA 022025, held by CLINIGEN 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 500MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 200752 | AP (A-rated, therapeutically equivalent) | October 19, 2011 | EQ 500MG BASE/VIAL |
| GLAND PHARMA LTD | 207321 | AP (A-rated, therapeutically equivalent) | November 28, 2016 | EQ 500MG BASE/VIAL |
| MSN LABORATORIES PRIVATE LTD | 216748 | AP (A-rated, therapeutically equivalent) | March 26, 2025 | EQ 500MG BASE/VIAL |
Questions
Is there a generic for Totect?
Yes. The generic name for Totect 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 Totect?
The active ingredient in Totect 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.