Active substance
Oxacillin
- US FDA 33
- WHO EML 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BACTOCILL IN PLASTIC CONTAINER | EQ 40MG BASE/ML | injectable · injection | BAXTER HLTHCARE | Prescription | 26 Oct 1989 |
| OXACILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | SAGENT PHARMS | Prescription | 30 Mar 2012 |
| OXACILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 18 Jan 2013 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | EUGIA PHARMA SPECLTS | Prescription | 18 Jan 2013 |
| OXACILLIN SODIUM | EQ 2GM BASE/VIAL | injectable · injection | ONESOURCE SPECIALTY | Prescription | 25 Aug 2014 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | WOCKHARDT BIO AG | Prescription | 31 Jul 2017 |
| OXACILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | WOCKHARDT BIO AG | Prescription | 24 Nov 2017 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 20 Jul 2020 |
| OXACILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | FRESENIUS KABI USA | Prescription | 27 Jul 2020 |
| OXACILLIN SODIUM | EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 10GM BASE/VIAL | injectable · injection | SANDOZ | Discontinued | 8 Apr 1971 |
| BACTOCILL | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | GLAXOSMITHKLINE | Discontinued | 27 Jul 1973 |
| OXACILLIN SODIUM | EQ 250MG BASE; EQ 500MG BASE | capsule · oral | ANI PHARMS | Discontinued | 10 Mar 1980 |
| OXACILLIN SODIUM | EQ 250MG BASE/5ML | for solution · oral | TEVA | Discontinued | 15 May 1980 |
| BACTOCILL | EQ 250MG BASE/5ML | for solution · oral | GLAXOSMITHKLINE | Discontinued | 2 Jun 1981 |
| BACTOCILL | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 4GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 10GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | GLAXOSMITHKLINE | Discontinued | 26 Mar 1982 |
| BACTOCILL | EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; EQ 2GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | GLAXOSMITHKLINE | Discontinued | 19 Dec 1986 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | powder · intravenous | SANDOZ | Discontinued | 23 Dec 1986 |
| OXACILLIN SODIUM | EQ 10GM BASE/VIAL | injectable · injection | WATSON LABS INC | Discontinued | 29 Sep 1988 |
| OXACILLIN SODIUM | EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL; EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 4GM BASE/VIAL | injectable · injection | WATSON LABS INC | Discontinued | 26 Oct 1988 |
| BACTOCILL IN PLASTIC CONTAINER | EQ 20MG BASE/ML | injectable · injection | BAXTER HLTHCARE | Discontinued | 26 Oct 1989 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL; EQ 125MG BASE/VIAL; EQ 250MG BASE/VIAL; EQ 500MG BASE/VIAL | injectable · injection | ACS DOBFAR SPA | Discontinued | 11 Dec 1995 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | SAGENT PHARMS | Discontinued | 30 Mar 2012 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL | injectable · injection | ONESOURCE SPECIALTY | Discontinued | 25 Aug 2014 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | HOSPIRA | Discontinued | 11 Dec 2015 |
| OXACILLIN SODIUM | EQ 1GM BASE/VIAL; EQ 2GM BASE/VIAL | injectable · injection | PIRAMAL CRITICAL | Discontinued | 11 Sep 2017 |
8 more — full table
WHO WHO Model List of Essential Medicines (2025)
- 6.2.1. Access group antibiotics · core
First choice: Therapeutic equivalent to cloxacillin for Bacterial infection of joint; First choice: Therapeutic equivalent to cloxacillin for Osteomyelitis or osteitis; First choice: Therapeutic equivalent to cloxacillin for Bacterial cellulitis, erysipelas or lymphangitis; Second choice: Therapeutic equivalent to cloxacillin for Sepsis without septic shock
Safety signals and safety-related labeling changes
- EMA PRAC 3 Sep 2026 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: Yes - US FDA 31 Aug 2026 BACTOCILL IN PLASTIC CONTAINER — safety-related labeling change
Labeling sections changed: Adverse Reactions - EMA PRAC 15 Jan 2026 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No - EMA PRAC 14 Apr 2016 PRAC signal: Metabolic acidosis following administration of flucloxacillin in association with paracetamol
Action for MAH: update of the product information: No
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.