Quick answers
- What is Plazomicin used for?
- The FDA-approved label (Zemdri (plazomicin), Cipla USA Inc., December 20, 2024) says: “1. INDICATIONS 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. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Plazomicin have a boxed warning?
- Yes. The FDA label for Zemdri (plazomicin) has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Plazomicin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Plazomicin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Plazomicin?
- 3 companies list prescription products of Plazomicin in the FDA NDC Directory, including Cipla USA Inc., Cipla Therapeutics Inc. and Achaogen, Inc..
What Plazomicin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS 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. As only limited clinical safety and efficacy data are available, reserve ZEMDRI for use in patients who have limited or no alternative treatment options. …
— FDA label: Zemdri (plazomicin), Cipla USA Inc., effective December 20, 2024. Read the full label on DailyMed →
The FDA has 3 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
3 of 3 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 3 in the FDA NDC Directory |
| Brand names | Zemdri (Plazomicin) |
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.
- Cipla USA Inc.1 product
- Cipla Therapeutics Inc.1 product
- Achaogen, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210303 ZEMDRI | Cipla USA | June 25, 2018 | 2, latest February 10, 2023 2023: Labeling · 2020: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 2049553, 2049558 |
|---|---|
| SPL set ID of the quoted label | eccf9fd9-53ac-4252-a106-5567b3a82a70 |
| FDA labels (SPL) | 3 |
| FDA applications | NDA210303 |
| Active ingredients (FDA) | PLAZOMICIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Zemdri (plazomicin), Cipla USA Inc., effective December 20, 2024; 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 →