Quick answers
- What is Aztreonam used for?
- The FDA-approved label (Azactam, E.R. Squibb & Sons, L.L.C., December 15, 2025) says: “To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Aztreonam have a boxed warning?
- No. None of the 6 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Aztreonam?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Aztreonam been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Aztreonam?
- 4 companies list prescription products of Aztreonam in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Hospira, Inc. and E.R. Squibb & Sons, L.L.C..
What Aztreonam is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. …
— FDA label: Azactam, E.R. Squibb & Sons, L.L.C., effective December 15, 2025. Read the full label on DailyMed →
The FDA has 6 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.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
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.
0 of 6 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, lyophilized, for solution · Injection, powder, for solution |
|---|---|
| Route | Intramuscular · Intravenous |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Azactam |
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.
- Fresenius Kabi USA, LLC6 products
- Hospira, Inc.2 products
- E.R. Squibb & Sons, L.L.C.2 products
- A-S Medication Solutions1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA050580 AZACTAM | Labs Delbert | December 31, 1986 | 27, latest April 16, 2021 2021: Labeling · 2018: Labeling · 2014: Manufacturing (CMC) |
Generic approvals (2)
- ANDA065439Fresenius Kabi USA · June 18, 2010
- ANDA206517Hospira · November 8, 2021
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) | 1664981, 1664984, 1664986, 1664988 |
|---|---|
| SPL set ID of the quoted label | 9a105eaf-ee77-4016-beeb-d425a5565db2 |
| FDA labels (SPL) | 6 |
| FDA applications | NDA050580, 2 ANDA |
| Active ingredients (FDA) | AZTREONAM |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Azactam, E.R. Squibb & Sons, L.L.C., effective December 15, 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 →