FDA Orange Book
Generic for Stelazine
Stelazine contains trifluoperazine. 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 Stelazine is trifluoperazine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Stelazine products the Orange Book lists.
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Stelazine products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| concentrate, oral | EQ 10MG BASE/ML | Discontinued | None | 0 | None |
| injectable, injection | EQ 2MG BASE/ML | Discontinued | None | 0 | None |
| tablet, oral | EQ 10MG BASE | Discontinued | None | 2 | AB |
| tablet, oral | EQ 1MG BASE | Discontinued | None | 2 | AB |
| tablet, oral | EQ 2MG BASE | Discontinued | None | 2 | AB |
| tablet, oral | EQ 5MG BASE | Discontinued | None | 2 | AB |
NDA 011552, held by GLAXOSMITHKLINE. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trifluoperazine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 040209 | AB (A-rated, therapeutically equivalent) | July 7, 1997 | EQ 10MG BASE, EQ 1MG BASE, EQ 2MG BASE, EQ 5MG BASE |
| SANDOZ INC | 085788 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 10MG BASE |
| SANDOZ INC | 085785 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 1MG BASE |
| SANDOZ INC | 085786 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 2MG BASE |
| SANDOZ INC | 085789 | AB (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | EQ 5MG BASE |
Questions
Is there a generic for Stelazine?
Yes. The generic name for Stelazine is trifluoperazine. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB. Generics match 4 of the 6 Stelazine products the Orange Book lists.
What is the generic name for Stelazine?
The active ingredient in Stelazine is trifluoperazine, 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.