FDA Orange Book
Generic for Zosyn
Zosyn contains piperacillin and tazobactam. 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 Zosyn is piperacillin and tazobactam. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Zosyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL | Discontinued | None | 9 | AP |
| injectable, injection | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL | Discontinued | None | 7 | AP |
| injectable, injection | EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL | Discontinued | None | 9 | AP |
| injectable, injection | EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL | Discontinued | None | 9 | AP |
NDA 050684, held by WYETH PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic piperacillin and tazobactam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SANDOZ INC | 065362 | AP (A-rated, therapeutically equivalent) | October 21, 2010 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 065498 | AP (A-rated, therapeutically equivalent) | May 23, 2011 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| ACS DOBFAR SPA | 065523 | AP (A-rated, therapeutically equivalent) | May 31, 2011 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| ACS DOBFAR SPA | 090498 | AP (A-rated, therapeutically equivalent) | May 31, 2011 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| ONESOURCE SPECIALTY PTE LTD | 065458 | AP (A-rated, therapeutically equivalent) | August 15, 2014 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| MILLA PHARMACEUTICALS INC | 207847 | AP (A-rated, therapeutically equivalent) | January 13, 2017 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| MILLA PHARMACEUTICALS INC | 207848 | AP (A-rated, therapeutically equivalent) | January 13, 2017 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| APOTEX INC | 207146 | AP (A-rated, therapeutically equivalent) | March 17, 2017 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| APOTEX INC | 206996 | AP (A-rated, therapeutically equivalent) | March 22, 2017 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| FRESENIUS KABI ANTI INFECTIVES SRL | 203720 | AP (A-rated, therapeutically equivalent) | May 11, 2018 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| FRESENIUS KABI ANTI INFECTIVES SRL | 203719 | AP (A-rated, therapeutically equivalent) | May 18, 2018 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| SHANDONG ANXIN PHARMACEUTICAL CO LTD | 204959 | AP (A-rated, therapeutically equivalent) | August 10, 2018 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 208674 | AP (A-rated, therapeutically equivalent) | February 16, 2021 | EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL, EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL, EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 208675 | AP (A-rated, therapeutically equivalent) | February 16, 2021 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| SANDOZ INC | 203557 | AP (A-rated, therapeutically equivalent) | July 8, 2021 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
| SHANDONG ANXIN PHARMACEUTICAL CO LTD | 217243 | AP (A-rated, therapeutically equivalent) | April 14, 2023 | EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL |
Questions
Is there a generic for Zosyn?
Yes. The generic name for Zosyn is piperacillin and tazobactam. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Zosyn?
The active ingredient in Zosyn is piperacillin and tazobactam, 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.
More on Zosyn and Piperacillin and Tazobactam
- What is Piperacillin and Tazobactam used for?FDA label uses
- Is Piperacillin and Tazobactam a controlled substance?Federal schedule
- Penicillin-class Antibacterials listFDA drug class
- Beta Lactamase Inhibitors listFDA drug class
- NDC 0206-8860Zosyn NDC record
- NDC 0206-8861Zosyn NDC record
- NDC 0206-8862Zosyn NDC record