FDA Orange Book
Generic for Unasyn
Unasyn contains ampicillin and sulbactam. 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 Unasyn is ampicillin and sulbactam. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Unasyn products the Orange Book lists.
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Unasyn products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL | Marketed (Rx) | AP | 7 | AP |
| injectable, injection | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL | Marketed (Rx) | AP | 7 | AP |
| injectable, injection | EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL | Marketed (Rx) | AP | 7 | AP |
| injectable, injection | EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL | Discontinued | None | 0 | None |
NDA 050608, 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 ampicillin and sulbactam
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 065076 | AP (A-rated, therapeutically equivalent) | March 19, 2002 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| HQ SPECIALTY PHARMA CORP | 065188 | AP (A-rated, therapeutically equivalent) | November 25, 2005 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| ACS DOBFAR SPA | 065222 | AP (A-rated, therapeutically equivalent) | November 29, 2005 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| HQ SPECIALTY PHARMA CORP | 065176 | AP (A-rated, therapeutically equivalent) | November 30, 2005 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| SANDOZ INC | 065240 | AP (A-rated, therapeutically equivalent) | July 25, 2006 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| SANDOZ INC | 065241 | AP (A-rated, therapeutically equivalent) | July 25, 2006 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| ACS DOBFAR SPA | 065314 | AP (A-rated, therapeutically equivalent) | November 27, 2006 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| ACS DOBFAR SPA | 065406 | AP (A-rated, therapeutically equivalent) | December 22, 2009 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| ACS DOBFAR SPA | 065403 | AP (A-rated, therapeutically equivalent) | December 23, 2009 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 090339 | AP (A-rated, therapeutically equivalent) | September 20, 2010 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 090349 | AP (A-rated, therapeutically equivalent) | September 20, 2010 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| ONESOURCE SPECIALTY PTE LTD | 202197 | AP (A-rated, therapeutically equivalent) | April 7, 2014 | EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL |
| ONESOURCE SPECIALTY PTE LTD | 201024 | AP (A-rated, therapeutically equivalent) | April 7, 2014 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
| ANTIBIOTICE SA | 201406 | AP (A-rated, therapeutically equivalent) | December 7, 2015 | EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL, EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL |
Unasyn NDC codes
Questions
Is there a generic for Unasyn?
Yes. The generic name for Unasyn is ampicillin and sulbactam. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Unasyn products the Orange Book lists.
What is the generic name for Unasyn?
The active ingredient in Unasyn is ampicillin and sulbactam, 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 Unasyn and Ampicillin and Sulbactam
- What is Ampicillin and Sulbactam used for?FDA label uses
- Is Ampicillin and Sulbactam a controlled substance?Federal schedule
- Penicillin-class Antibacterials listFDA drug class
- Beta Lactamase Inhibitors listFDA drug class
- NDC 0049-0013Unasyn NDC record
- NDC 0049-0014Unasyn NDC record
- NDC 0049-0024Unasyn NDC record