FDA Orange Book
Generic for Sectral
Sectral contains acebutolol. 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 Sectral is acebutolol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Sectral products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 200MG BASE | Discontinued | None | 2 | AB |
| capsule, oral | EQ 400MG BASE | Discontinued | None | 2 | AB |
NDA 018917, held by PROMIUS PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic acebutolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ANI PHARMACEUTICALS INC | 074007 | AB (A-rated, therapeutically equivalent) | October 18, 1995 | EQ 200MG BASE, EQ 400MG BASE |
| AMNEAL PHARMACEUTICAL | 075047 | AB (A-rated, therapeutically equivalent) | December 30, 1999 | EQ 200MG BASE, EQ 400MG BASE |
Questions
Is there a generic for Sectral?
Yes. The generic name for Sectral is acebutolol. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Sectral?
The active ingredient in Sectral is acebutolol, 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.