Prescription medicine

Ceftolozane and tazobactam Brand names: Zerbaxa

Ceftolozane and tazobactam (Zerbaxa) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the ceftolozane and tazobactam FDA label on DailyMed (effective May 12, 2026, Merck Sharp & Dohme LLC); the NDA 206829 record on Drugs@FDA; every ceftolozane and tazobactam label on DailyMed.

Highlights of the record

FDA label of May 12, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
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.

Forms and strengths

1 g/10ml / 0.5 g/10ml

Injection (powder) (lyophilized) for solution.

On the market

Earliest approval on file: December 19, 2014 Zerbaxa, Cubist Pharms Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: February 14, 2036 Zerbaxa injection; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): 1 since 2020 0 Class I among all firms' recalls; latest December 21, 2020
FAERS reports: 965 through July 30, 2026

What is ceftolozane and tazobactam used for?

From the label: indications and usage
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. ( 1.1 ) Complicated Urinary Tract Infections (cUTI), Including Pyelonephritis. ( 1.2 ) Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia (HABP/VABP). […]

Conditions named in the indications of ceftolozane and tazobactam's FDA labels, with every medicine labeled for each:

Urinary tract infections

From other ceftolozane and tazobactam labels
Urinary tract infections: Complicated Urinary Tract Infections, Including Pyelonephritis ZERBAXA is indicated for the treatment of adult and pediatric patients (at least 32 weeks gestational age) with complicated urinary tract infections (cUTI), including …

FDA pharmacologic class: Cephalosporin Antibacterial and beta Lactamase Inhibitor.

Source: FDA drug label (ZERBAXA), NDA206829 (Cubist Pharms Llc), as published by Merck Sharp & Dohme LLC, effective May 12, 2026 (SPL set 70ac1d90-eff3-4f0b-9f46-5846c571b32f), via openFDA; the full label on DailyMed

Is there a generic for ceftolozane and tazobactam (Zerbaxa)?

No generic ceftolozane and tazobactam is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 12 patents for Zerbaxa injection: the compound patent runs to May 28, 2034 (pediatric exclusivity to November 28, 2034), and the last listed entry to February 14, 2036. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2014 earliest approval on file
2036 last listed patent
red ticks recalls

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

Has ceftolozane and tazobactam been recalled?

The FDA's Enforcement Report lists 1 recall naming ceftolozane and tazobactam since 2020: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.

Started	Class	Company	Reason
December 21, 2020	Class II	Merck Sharp & Dohme	Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. …

Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026

What does the ceftolozane and tazobactam label say about other medicines?

The ceftolozane and tazobactam label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Meropenem	warnings and precautions	Baseline Renal Function: CrCl greater than 50 mL/min; ZERBAXA plus Metronidazole n/N (%): 312/366 (85.2); Meropenem n/N (%): 355/404 (87.9)
Metronidazole	warnings and precautions	Baseline Renal Function: CrCl greater than 50 mL/min; ZERBAXA plus Metronidazole n/N (%): 312/366 (85.2); Meropenem n/N (%): 355/404 (87.9)

Check ceftolozane and tazobactam against other medicines

What do FAERS reports show for ceftolozane and tazobactam?

The FDA Adverse Event Reporting System holds 965 reports that list ceftolozane and tazobactam among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 228 are coded as a death and 265 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

Reports received each year

The most reported reactions

Off Label Use (a use or a product term, not a reaction)138
Product Use In Unapproved Indication (a use or a product term, not a reaction)128
No Adverse Event (a use or a product term, not a reaction)89
Death (an outcome recorded in the report)81
Product Use Issue (a use or a product term, not a reaction)67
Pathogen Resistance54
Drug Ineffective (a use or a product term, not a reaction)44
Drug Resistance30

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as ceftolozane and tazobactam?

14 other medicines are given the same way (intravenous) and in the same FDA class as ceftolozane and tazobactam or labeled mainly for the same use (urinary tract infections), the same class first. Urinary tract infections lists all 39 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (intravenous)	Pharmacy cost	Shortage
Cefazolin	Urinary tract infections	7 labelers	$1.07 per vial 1 g vial	No current entry
Cefepime	Urinary tract infections	8 labelers	n/a	A presentation being discontinued
Cefoxitin	Urinary tract infections	5 labelers	n/a	No current entry
Ceftriaxone	Urinary tract infections	7 labelers	$1.44 per vial 1 g vial	No current entry
Cefuroxime	Urinary tract infections	2 labelers	n/a	No current entry
Avibactam and ceftazidime	Urinary tract infections	none listed	n/a	No current entry
Cefepime and zidebactam	Urinary tract infections	none listed	n/a	No current entry
Cefiderocol	Urinary tract infections	none listed	n/a	No current entry

Every medicine labeled for the same conditions as ceftolozane and tazobactam

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to ceftolozane and tazobactam: 14 medicines for the same use
Other cephalosporins: the pharmacologic class, with prices and generics
Ceftolozane and tazobactam side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other