FDA Orange Book
Generic for Zyvox
Zyvox contains linezolid. 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 Zyvox is linezolid. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 6 Zyvox products the Orange Book lists.
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Zyvox products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 100MG/5ML | Marketed (Rx) | AB | 2 | AB |
| solution, intravenous | 200MG/100ML (2MG/ML) | Marketed (Rx) | AP | 5 | AP |
| solution, intravenous | 400MG/200ML (2MG/ML) | Discontinued | None | 0 | None |
| solution, intravenous | 600MG/300ML (2MG/ML) | Marketed (Rx) | AP | 9 | AP |
| tablet, oral | 400MG | Discontinued | None | 0 | None |
| tablet, oral | 600MG | Discontinued | None | 9 | AB |
NDA 021132, 021131, 021130, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic linezolid
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 200068 | AB (A-rated, therapeutically equivalent) | June 3, 2015 | 100MG/5ML |
| SANDOZ INC | 200904 | AP (A-rated, therapeutically equivalent) | July 16, 2015 | 200MG/100ML (2MG/ML), 600MG/300ML (2MG/ML) |
| ALEMBIC PHARMACEUTICALS LTD | 205233 | AB (A-rated, therapeutically equivalent) | December 21, 2015 | 600MG |
| ALKEM LABORATORIES LTD | 205517 | AB (A-rated, therapeutically equivalent) | December 21, 2015 | 600MG |
| GLENMARK SPECIALTY SA | 078987 | AB (A-rated, therapeutically equivalent) | December 21, 2015 | 600MG |
| HETERO LABS LTD UNIT V | 204239 | AB (A-rated, therapeutically equivalent) | December 21, 2015 | 600MG |
| RISING PHARMA HOLDINGS INC | 078845 | AB (A-rated, therapeutically equivalent) | December 21, 2015 | 600MG |
| FRESENIUS KABI USA LLC | 204764 | AP (A-rated, therapeutically equivalent) | March 15, 2016 | 600MG/300ML (2MG/ML) |
| EUGIA PHARMA SPECIALITIES LTD | 206917 | AP (A-rated, therapeutically equivalent) | August 4, 2016 | 600MG/300ML (2MG/ML) |
| NOVEL LABORATORIES INC | 207526 | AB (A-rated, therapeutically equivalent) | August 22, 2016 | 600MG |
| NANG KUANG PHARMACEUTICAL CO LTD | 207354 | AP (A-rated, therapeutically equivalent) | December 20, 2016 | 200MG/100ML (2MG/ML), 600MG/300ML (2MG/ML) |
| ZYDUS PHARMACEUTICALS USA INC | 206097 | AB (A-rated, therapeutically equivalent) | February 22, 2017 | 600MG |
| SAGENT PHARMACEUTICALS INC | 204696 | AP (A-rated, therapeutically equivalent) | March 2, 2017 | 200MG/100ML (2MG/ML), 600MG/300ML (2MG/ML) |
| HQ SPECIALTY PHARMA CORP | 207001 | AP (A-rated, therapeutically equivalent) | July 7, 2017 | 200MG/100ML (2MG/ML), 600MG/300ML (2MG/ML) |
| STERISCIENCE PTE LTD | 205154 | AP (A-rated, therapeutically equivalent) | December 6, 2017 | 200MG/100ML (2MG/ML), 600MG/300ML (2MG/ML) |
| CHARTWELL RX SCIENCES LLC | 210702 | AB (A-rated, therapeutically equivalent) | April 25, 2019 | 600MG |
| HIKMA PHARMACEUTICALS USA INC | 206454 | AP (A-rated, therapeutically equivalent) | August 22, 2022 | 600MG/300ML (2MG/ML) |
| HETERO LABS LTD | 211813 | AB (A-rated, therapeutically equivalent) | October 31, 2022 | 100MG/5ML |
| MACLEODS PHARMACEUTICALS LTD | 210378 | AB (A-rated, therapeutically equivalent) | October 10, 2024 | 600MG |
| CAPLIN STERILES LTD | 219558 | AP (A-rated, therapeutically equivalent) | December 8, 2025 | 600MG/300ML (2MG/ML) |
Zyvox NDC codes
Questions
Is there a generic for Zyvox?
Yes. The generic name for Zyvox is linezolid. 19 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB, AP. Generics match 4 of the 6 Zyvox products the Orange Book lists.
What is the generic name for Zyvox?
The active ingredient in Zyvox is linezolid, 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.