FDA Orange Book
Generic for Ultane
Ultane contains sevoflurane. 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 Ultane is sevoflurane. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
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Ultane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| liquid, inhalation | 100% | Marketed (Rx) | AN | 5 | AN |
NDA 020478, held by ABBVIE INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic sevoflurane
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAXTER HEALTHCARE CORP | 075895 | AN (A-rated, therapeutically equivalent) | July 2, 2002 | 100% |
| PIRAMAL CRITICAL CARE INC | 077867 | AN (A-rated, therapeutically equivalent) | May 2, 2007 | 100% |
| HALOCARBON PRODUCTS CORP | 078650 | AN (A-rated, therapeutically equivalent) | November 19, 2007 | 100% |
| SHANGHAI HENGRUI PHARMACEUTICAL CO LTD | 203793 | AN (A-rated, therapeutically equivalent) | November 3, 2015 | 100% |
| SHANDONG NEW TIME PHARMACEUTICAL CO LTD | 214382 | AN (A-rated, therapeutically equivalent) | August 18, 2023 | 100% |
Ultane NDC codes
Questions
Is there a generic for Ultane?
Yes. The generic name for Ultane is sevoflurane. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AN.
What is the generic name for Ultane?
The active ingredient in Ultane is sevoflurane, 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.