Prescription medicine
Oxacillin First approved as Bactocill
Oxacillin (Bactocill) is a prescription medicine with an FDA approval on record since 1989. FDA's NDC Directory lists it from 5 generic labelers.
- Generic listed
Check it at the source: the oxacillin FDA label on DailyMed (effective December 31, 2025, Onesource Specialty Pharma Limited); the NDA 50640 record on Drugs@FDA; every oxacillin label on DailyMed.
Highlights of the record
FDA label of December 31, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug.
Forms and strengths
- 1 g
- 2 g
- 1 g/20ml
- 2 g/20ml
- 2 g/50ml
- 10 g/100ml
Injection (powder) for solution; powder for solution; injection (solution).
On the market
- Earliest approval on file
- October 26, 1989 Bactocill In Plastic Container, Baxter Hlthcare; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 23 first April 8, 1971; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 6 of which 5 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 4 since 2015 0 Class I among all firms' recalls; latest July 11, 2023; 1 more by firms not listed as its makers
- FAERS reports
- 1,116 through July 30, 2026
What is oxacillin used for?
From the label: indications and usageOxacillin 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 (See CLINICAL PHARMACOLOGY – Susceptibility Test Methods ). Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. […]
FDA pharmacologic class: Penicillin-class Antibacterial.
Source: FDA drug label (oxacillin), Onesource Specialty Pharma Limited, effective December 31, 2025 (SPL set 4972ec74-1d9a-de9b-e063-6394a90af786), via openFDA; the full label on DailyMed
Is there a generic for oxacillin (Bactocill)?
The FDA approved the first generic oxacillin on April 8, 1971. 23 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists oxacillin from 5 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1989 earliest approval on file
- 1971 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has oxacillin been recalled?
The FDA's Enforcement Report lists 5 recalls naming oxacillin since 2015: 0 Class I (the most serious), 5 Class II, 0 Class III; 3 still ongoing. 1 of them is by a firm that FDA's NDC Directory does not list as a maker of oxacillin and that holds no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 11, 2023 | Class II | Sagent Pharmaceuticals | Lack of Assurance of Sterility |
| June 13, 2016 | Class II | Sagent Pharmaceuticals Inc | Presence of Particulate Matter; The firm received two product complaints for small, dark particulate matter identified in solution post reconstitution. |
| November 10, 2015 | Class II | Walgreens Infusion Services not a listed maker | Lack of Assurance of Sterility |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the oxacillin label say about other medicines?
The oxacillin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name oxacillin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Probenecid | drug interactions | Oxacillin blood levels may be increased and prolonged by concurrent administration of probenecid which blocks the renal tubular secretion of penicillins. |
| Tetracycline | drug interactions | DRUG INTERACTIONS Tetracycline, a bacteriostatic antibiotic, may antagonize the bactericidal effect of penicillin and concurrent use of these drugs should be avoided. |
Other labels that name oxacillin
Source: FDA drug label (oxacillin), Onesource Specialty Pharma Limited, effective December 31, 2025 (SPL set 4972ec74-1d9a-de9b-e063-6394a90af786), via openFDA; the full label on DailyMed
What do FAERS reports show for oxacillin?
The FDA Adverse Event Reporting System holds 1,116 reports that list oxacillin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 214 are coded as a death and 599 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other penicillins
- the pharmacologic class, with prices and generics
- Oxacillin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other