Quick answers
- What is Sulopenem etzadroxil and probenecid used for?
- The FDA-approved label (Orlynvah, Iterum Therapeutics Us Limited, December 6, 2025) says: “ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Sulopenem etzadroxil and probenecid 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 Sulopenem etzadroxil and probenecid?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Sulopenem etzadroxil and probenecid been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Sulopenem etzadroxil and probenecid?
- 1 company lists prescription products of Sulopenem etzadroxil and probenecid in the FDA NDC Directory, including Iterum Therapeutics US Limited.
What Sulopenem etzadroxil and probenecid is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. …
— FDA label: Orlynvah, Iterum Therapeutics Us Limited, effective December 6, 2025. 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.
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 | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Orlynvah |
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.
- Iterum Therapeutics US Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA213972 ORLYNVAH | Iterum Therap | October 25, 2024 | 2, latest December 23, 2025 2025: Labeling · 2025: 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) | 2717843, 2717850 |
|---|---|
| SPL set ID of the quoted label | 24c451c0-4cfb-37f3-e063-6394a90a895e |
| FDA labels (SPL) | 1 |
| FDA applications | NDA213972 |
| Active ingredients (FDA) | PROBENECID / SULOPENEM ETZADROXIL |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Orlynvah, Iterum Therapeutics Us Limited, effective December 6, 2025; 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 →