FDA Orange Book
Generic for Tracrium
Tracrium contains atracurium. 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 Tracrium is atracurium. 3 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Tracrium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 10MG/ML | Discontinued | None | 6 | AP |
NDA 018831, held by HOSPIRA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic atracurium
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074901 | AP (A-rated, therapeutically equivalent) | July 18, 1997 | 10MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 074900 | AP (A-rated, therapeutically equivalent) | July 18, 1997 | 10MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 091489 | AP (A-rated, therapeutically equivalent) | February 17, 2012 | 10MG/ML |
| MEITHEAL PHARMACEUTICALS INC | 091488 | AP (A-rated, therapeutically equivalent) | February 17, 2012 | 10MG/ML |
| HOSPIRA INC | 090761 | AP (A-rated, therapeutically equivalent) | October 18, 2012 | 10MG/ML |
| HOSPIRA INC | 090782 | AP (A-rated, therapeutically equivalent) | October 18, 2012 | 10MG/ML |
Questions
Is there a generic for Tracrium?
Yes. The generic name for Tracrium is atracurium. 3 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 Tracrium?
The active ingredient in Tracrium is atracurium, 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.