Prescription medicine
Cefepime and zidebactam Brand names: Zaynich
Cefepime and zidebactam (Zaynich) is a prescription medicine with an FDA approval on record since 2026. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the cefepime and zidebactam FDA label on DailyMed (effective June 5, 2026, Wockhardt Suisse USA LLC); the NDA 220787 record on Drugs@FDA; every cefepime and zidebactam label on DailyMed.
Highlights of the record
FDA label of June 5, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms.
Forms and strengths
- 1 g / 2 g
Injection (powder) for solution.
On the market
- Earliest approval on file
- May 29, 2026 Zaynich, Wockhardt Bio Ag; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- October 12, 2033 Zaynich 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)
- No recall recorded
What is cefepime and zidebactam used for?
From the label: indications and usageZAYNICH is a combination of cefepime, a cephalosporin antibacterial, and zidebactam, a beta-lactamase inhibitor and non-beta-lactam antibacterial indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by designated susceptible microorganisms. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of ZAYNICH and other antibacterial drugs, ZAYNICH should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of cefepime and zidebactam's FDA labels, with every medicine labeled for each:
From other cefepime and zidebactam labelsUrinary tract infections: Complicated Urinary Tract Infections, including Pyelonephritis ZAYNICH is indicated for the treatment of adult patients with complicated urinary tract infections (cUTI) including pyelonephritis caused by the following susceptible …
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (ZAYNICH), Wockhardt Suisse USA LLC, effective June 5, 2026 (SPL set c84e652e-5e76-4568-8812-bd5fa34803b6), via openFDA; the full label on DailyMed
Is there a generic for cefepime and zidebactam (Zaynich)?
No generic cefepime and zidebactam is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Zaynich injection: the compound patent runs to October 12, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2026 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the cefepime and zidebactam label say about other medicines?
The cefepime and zidebactam label names 1 other medicine 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 |
|---|---|---|
| Furosemide | drug interactions | Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide. |
Source: FDA drug label (ZAYNICH), Wockhardt Suisse USA LLC, effective June 5, 2026 (SPL set c84e652e-5e76-4568-8812-bd5fa34803b6), via openFDA; the full label on DailyMed
What else is labeled for the same conditions as cefepime and zidebactam?
13 other medicines are given the same way (intravenous) and in the same FDA class as cefepime and zidebactam 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 |
| 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 |
| Cefiderocol | Urinary tract infections | none listed | n/a | No current entry |
| Ceftolozane and tazobactam | Urinary tract infections | none listed | n/a | No current entry |
| Doxycycline | Urinary tract infections | 20 labelers | n/a | A presentation being discontinued |
Every medicine labeled for the same conditions as cefepime and zidebactam
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to cefepime and zidebactam
- 13 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Check an interaction
- what two or more labels say about each other