Prescription medicine
Plazomicin Brand names: Zemdri
Plazomicin (Zemdri) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the plazomicin FDA label on DailyMed (effective December 20, 2024, Cipla USA Inc.); the NDA 210303 record on Drugs@FDA; every plazomicin label on DailyMed.
Highlights of the record
FDA label of December 20, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
NEPHROTOXICITY, OTOTOXICITY, NEUROMUSCULAR.
BLOCKADE and FETAL HARM Nephrotoxicity has been reported with ZEMDRI. The risk of nephrotoxicity is greater in patients with impaired renal function, the elderly, and in those receiving concomitant nephrotoxic medications. Assess creatinine clearance in all patients prior to initiating therapy and daily during therapy [see Dosage and Administration (2.2) and Warnings and Precautions (5.1) ]. Therapeutic Drug Monitoring (TDM) is recommended for complicated urinary tract infection (cUTI) patients with CLcr less than 90 mL/min to avoid potentially toxic levels [see Dosage and Administration (2.3 , 2.4) ]. Ototoxicity, manifested as hearing loss, tinnitus, and/or vertigo, has been reported with ZEMDRI. Symptoms of aminoglycoside-associated ototoxicity may be irreversible and may not become evident until after completion of therapy. Aminoglycoside-associated ototoxicity has been observed primarily in patients with a family history of hearing loss, patients with renal impairment, and in patients receiving higher doses and/or longer durations of therapy than recommended [see Warnings and Precautions (5.2) ]. Aminoglycosides have been associated with neuromuscular blockade. […]
Used for
From the label: indications and usageINDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis.
Forms and strengths
- 500 mg/10ml
Injection.
On the market
- Earliest approval on file
- June 25, 2018 Zemdri, Cipla Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 3 of which 0 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- June 25, 2032 Zemdri 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
- FAERS reports
- 3 through July 30, 2026
What is plazomicin used for?
From the label: indications and usageINDICATIONS AND USAGE ZEMDRI is an aminoglycoside antibacterial indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. ( 1.1 ) As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain effectiveness of ZEMDRI and other antibacterial drugs, ZEMDRI should be used only to treat infections that are proven or strongly suspected to be caused by susceptible microorganisms. […]
Conditions named in the indications of plazomicin's FDA labels, with every medicine labeled for each:
From other plazomicin labelsUrinary tract infections: Infections (cUTI), including Pyelonephritis ZEMDRI is indicated in patients 18 years of age or older for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis caused by the following susceptible …
Source: FDA drug label (Zemdri (plazomicin)), Cipla USA Inc., effective December 20, 2024 (SPL set eccf9fd9-53ac-4252-a106-5567b3a82a70), via openFDA; the full label on DailyMed
Is there a generic for plazomicin (Zemdri)?
No generic plazomicin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Zemdri injection: the compound patent runs to June 25, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2032 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the plazomicin label say about other medicines?
The plazomicin 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 |
|---|---|---|
| Streptomycin | warnings and precautions | Aminoglycosides cross the placenta, and streptomycin has been associated with several reports of total, irreversible, bilateral congenital deafness in pediatric patients exposed in utero. |
Source: FDA drug label (Zemdri (plazomicin)), Cipla USA Inc., effective December 20, 2024 (SPL set eccf9fd9-53ac-4252-a106-5567b3a82a70), via openFDA; the full label on DailyMed
What do FAERS reports show for plazomicin?
The FDA Adverse Event Reporting System holds 3 reports that list plazomicin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 1 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as plazomicin?
12 other medicines are given the same way (intravenous) and in the same FDA class as plazomicin 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 |
|---|---|---|---|---|
| Doxycycline | Urinary tract infections | 20 labelers | n/a | A presentation being discontinued |
| 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 |
| Ceftriaxone | Urinary tract infections | 7 labelers | $1.44 per vial 1 g vial | 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 |
| Ceftolozane and tazobactam | Urinary tract infections | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as plazomicin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to plazomicin
- 12 medicines for the same use
- Plazomicin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other