FDA Orange Book
Generic for Amidate
Amidate contains etomidate. 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 Amidate is etomidate. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Amidate products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2MG/ML | Marketed (Rx) | AP | 7 | AP |
NDA 018227, 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 etomidate
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 074593 | AP (A-rated, therapeutically equivalent) | November 4, 1996 | 2MG/ML |
| ZYDUS PHARMACEUTICALS USA INC | 202360 | AP (A-rated, therapeutically equivalent) | July 18, 2014 | 2MG/ML |
| HIKMA FARMACEUTICA PORTUGAL SA | 202354 | AP (A-rated, therapeutically equivalent) | February 25, 2016 | 2MG/ML |
| MYLAN LABORATORIES LTD | 201044 | AP (A-rated, therapeutically equivalent) | February 7, 2017 | 2MG/ML |
| EUGIA PHARMA SPECIALITIES LTD | 206126 | AP (A-rated, therapeutically equivalent) | February 24, 2017 | 2MG/ML |
| GLAND PHARMA LTD | 209058 | AP (A-rated, therapeutically equivalent) | April 18, 2017 | 2MG/ML |
| CAPLIN STERILES LTD | 215028 | AP (A-rated, therapeutically equivalent) | December 18, 2020 | 2MG/ML |
Amidate NDC codes
Questions
Is there a generic for Amidate?
Yes. The generic name for Amidate is etomidate. 7 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 Amidate?
The active ingredient in Amidate is etomidate, 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.