Quick answers
- What is Oxacillin used for?
- The FDA-approved label (Oxacillin, Baxter Healthcare Corporation, August 31, 2026) says: “Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Oxacillin have a boxed warning?
- No. None of the 9 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Oxacillin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Oxacillin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Oxacillin?
- 6 companies list prescription products of Oxacillin in the FDA NDC Directory, including Fresenius Kabi USA, LLC, Eugia US LLC and Wockhardt USA LLC..
What Oxacillin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. …
— FDA label: Oxacillin, Baxter Healthcare Corporation, effective August 31, 2026. Read the full label on DailyMed →
The FDA has 9 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.
The label quoted above has no boxed warning.
0 of 9 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Injection, powder, for solution · Injection, solution · Powder, for solution |
|---|---|
| Route | Intravenous · Intramuscular |
| Prescription products | 13 in the FDA NDC Directory |
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, LLC3 products
- Eugia US LLC3 products
- Wockhardt USA LLC.3 products
- Onesource Specialty Pharma Limited2 products
- Armas Pharmaceuticals Inc.1 product
- Baxter Healthcare Corporation1 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 |
|---|---|---|---|
| NDA050640 BACTOCILL IN PLASTIC CONTAINER | Baxter Hlthcare | October 26, 1989 | 14, latest August 31, 2026 2026: Labeling · 2017: Labeling · 2015: Labeling |
Generic approvals (7)
- ANDA201538Eugia Pharma Speclts · January 18, 2013
- ANDA201539Eugia Pharma Speclts · January 18, 2013
- ANDA091486Onesource Specialty · August 25, 2014
- ANDA207147Wockhardt Bio AG · July 31, 2017
- ANDA207148Wockhardt Bio AG · November 24, 2017
- ANDA206198Fresenius Kabi USA · July 20, 2020
- ANDA206199Fresenius Kabi USA · July 27, 2020
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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Oxacillin, Baxter Healthcare Corporation, effective August 31, 2026; 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 →