Quick answers
- What is Ceftolozane and tazobactam used for?
- The FDA-approved label (Zerbaxa, Merck Sharp & Dohme LLC, May 12, 2026) says: “ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ceftolozane and tazobactam have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Ceftolozane and tazobactam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ceftolozane and tazobactam been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started December 21, 2020 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Ceftolozane and tazobactam?
- 1 company lists prescription products of Ceftolozane and tazobactam in the FDA NDC Directory, including Merck Sharp & Dohme LLC.
What Ceftolozane and tazobactam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ZERBAXA (ceftolozane and tazobactam) is a combination of ceftolozane, a cephalosporin antibacterial, and tazobactam, a beta-lactamase inhibitor, indicated for the treatment of the following infections caused by designated susceptible microorganisms in adult and pediatric patients (at least 32 weeks gestational age): Complicated Intra-abdominal Infections (cIAI), used in combination with metronidazole. …
— FDA label: Zerbaxa, Merck Sharp & Dohme LLC, effective May 12, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution |
|---|---|
| Route | Intravenous |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Zerbaxa |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Merck Sharp & Dohme LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206829 ZERBAXA | Cubist Pharms LLC | December 19, 2014 | 9, latest May 12, 2026 2026: Efficacy · 2022: Efficacy · 2022: Efficacy |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
December 21, 2020 · Class II · Terminated · D-0176-2021
Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the regist
Zerbaxa (ceftolozane and tazobactam) 1.5g per vial for injection, Single-Dose vial, Rx only, Manuf. for: Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc., NDC 67919-030-01 — Merck Sharp & Dohme
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
| RxCUI (RxNorm) | 1597615, 1597620 |
|---|---|
| SPL set ID of the quoted label | 70ac1d90-eff3-4f0b-9f46-5846c571b32f |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206829 |
| Active ingredients (FDA) | CEFTOLOZANE / TAZOBACTAM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zerbaxa, Merck Sharp & Dohme LLC, effective May 12, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →