Quick answers
- What is Pivmecillinam used for?
- The FDA-approved label (Pivya, Alembic Pharmaceuticals Inc., October 10, 2025) says: “1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Pivmecillinam 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 Pivmecillinam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Pivmecillinam been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Pivmecillinam?
- 1 company lists prescription products of Pivmecillinam in the FDA NDC Directory, including Alembic Pharmaceuticals Inc..
What Pivmecillinam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
1. INDICATIONS AND USAGE PIVYA is a penicillin class antibacterial indicated for the treatment of female patients 18 years of age and older with uncomplicated urinary tract infections (uUTI) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. …
— FDA label: Pivya, Alembic Pharmaceuticals Inc., effective October 10, 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, coated |
|---|---|
| Route | Oral |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Pivya |
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.
- Alembic Pharmaceuticals 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 |
|---|---|---|---|
| NDA216483 PIVYA | Alembic Therap | April 24, 2024 | — |
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) | 2715865, 2715871 |
|---|---|
| SPL set ID of the quoted label | 440a5f17-ab11-0fc8-e063-6394a90a58e9 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA216483 |
| Active ingredients (FDA) | PIVMECILLINAM HYDROCHLORIDE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Pivya, Alembic Pharmaceuticals Inc., effective October 10, 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 →