FDA Orange Book
Generic for Brevital Sodium
Brevital Sodium contains methohexital. 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 Brevital Sodium is methohexital. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Brevital Sodium products the Orange Book lists.
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Brevital Sodium products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 2.5GM/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 200MG/VIAL | Discontinued | None | 0 | None |
| injectable, injection | 500MG/VIAL | Marketed (Rx) | AP | 1 | AP |
| injectable, injection | 5GM/VIAL | Discontinued | None | 0 | None |
NDA 011559, held by PH HEALTH LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic methohexital
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ONESOURCE SPECIALTY PTE LTD | 215488 | AP (A-rated, therapeutically equivalent) | October 3, 2024 | 500MG/VIAL |
Brevital Sodium NDC codes
Questions
Is there a generic for Brevital Sodium?
Yes. The generic name for Brevital Sodium is methohexital. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 4 Brevital Sodium products the Orange Book lists.
What is the generic name for Brevital Sodium?
The active ingredient in Brevital Sodium is methohexital, 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.