Oxacillin Sodium

Treats infections caused by penicillinase producing staphylococci. Sold as Prostaphlin, Oxacillin Sodium, Bactocill In Plastic Container. Every FDA application for this active ingredient: 4 branded and 27 generic.

As of Nov 15, 2026, FDA lists 31 applications for Oxacillin Sodium (sold as Prostaphlin, Oxacillin Sodium, Bactocill In Plastic Container), first approved Oct 26, 1989, with 0 new uses approved and 0 published complete response letters.

First approved: Oct 26, 1989
Applications: 31
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $1.9M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Oxacillin Sodium	Part D	$1.9M	-16%	690

Clinical Trials

10 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive SurgerySurgical Wound Infection, Neck Infection · Tejs Ehlers Klug	Phase 4	Recruiting	Oct 26, 2026
Continuous Antibiotic Infusion In ChildrenInfection · Tampere University Hospital	Phase 3	Recruiting	May 8, 2026
Cefazolin Versus Antistaphylococcal Penicillins for Methicillin Susceptible Staphylococcus Aureus BacteremiaBacteriemia, Methicillin Susceptible Staphylococcus Aureus (MSSA) Infection · Central Hospital, Nancy, France	—	Active, not recruiting	Sep 22, 2025
Does Staphylococcus Aureus Bacteremia Early Dual Therapy Improve Outcomes?Staphylococcus Aureus Bacteremia · West Virginia University	Phase 4	Enrolling by invitation	Aug 29, 2025
Amnioinfusion for Fetal Renal FailureMulticystic Dysplastic Kidney, Polycystic Kidney Disease · Fetal Care Center, PLLC	Not applicable	Recruiting	Dec 11, 2024
Comparison of Cloxacillin and Benzylpenicillin in Penicillin Susceptible S. Aureus BacteraemiaStaphylococcus Aureus Bacteraemia, Staphylococcal Bacteraemia · Region Skane	Phase 4	Recruiting	Dec 10, 2024
Urogenital Infections in Women of Reproductive Age and the Activity of 4-Thiazolidinone Derivatives Against PathogensBacterial Vaginosis · Danylo Halytsky Lviv National Medical University	Phase 1	Active, not recruiting	Sep 27, 2024
Efficacy of LiveSpo Navax in Supportive Treatment of Pneumonia in Children With RSV and Bacterial Co-infectionsAcute Respiratory Tract Infections, Pneumonia · National Children's Hospital, Vietnam	Not applicable	Active, not recruiting	Jul 3, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 8, 1971	Oxacillin SodiumANDA 61490	Sandoz	10	Discontinued
Jul 27, 1973	BactocillANDA 61336	Glaxosmithkline	0	Discontinued
Mar 10, 1980	Oxacillin SodiumANDA 62222	Ani Pharms	3	Discontinued
May 15, 1980	Oxacillin SodiumANDA 62252	Chartwell Rx	5	Discontinued
Jun 2, 1981	BactocillANDA 62321	Glaxosmithkline	0	Discontinued
Mar 26, 1982	BactocillANDA 61334	Glaxosmithkline	0	Discontinued
Dec 19, 1986	BactocillANDA 62736	Glaxosmithkline	1	Discontinued
Dec 23, 1986	Oxacillin SodiumANDA 62737	Sandoz	6	Discontinued
Sep 29, 1988	Oxacillin SodiumANDA 62984	Chartwell Rx	15	Discontinued
Oct 26, 1988	Oxacillin SodiumANDA 62856	Chartwell Rx	18	Discontinued
Oct 26, 1989	Bactocill In Plastic ContainerNDA 50640 · New dosage form	Baxter Hlthcare	14	Marketed
Dec 11, 1995	Oxacillin SodiumANDA 62798	Acs Dobfar Spa	1	Discontinued
Mar 30, 2012	Oxacillin SodiumANDA 91246	Sagent Pharms	1	Discontinued
Mar 30, 2012	Oxacillin SodiumANDA 91245	Sagent Pharms	0	Marketed
Jan 18, 2013	Oxacillin SodiumANDA 201538	Eugia Pharma Speclts	1	Marketed
Jan 18, 2013	Oxacillin SodiumANDA 201539	Eugia Pharma Speclts	2	Marketed
Aug 25, 2014	Oxacillin SodiumANDA 91486	Onesource Specialty	1	Marketed
Dec 11, 2015	Oxacillin SodiumANDA 203950	Hospira	0	Discontinued
Jul 31, 2017	Oxacillin SodiumANDA 207147	Wockhardt Bio AG	1	Marketed
Sep 11, 2017	Oxacillin SodiumANDA 206681	Piramal Critical	0	Discontinued
Oct 26, 2017	Oxacillin SodiumANDA 206760	Piramal Critical	0	Discontinued
Nov 24, 2017	Oxacillin SodiumANDA 207148	Wockhardt Bio AG	0	Marketed
Jul 20, 2020	Oxacillin SodiumANDA 206198	Fresenius Kabi USA	0	Marketed
Jul 27, 2020	Oxacillin SodiumANDA 206199	Fresenius Kabi USA	0	Marketed
—	Oxacillin SodiumANDA 61450	Apothecon	0	Discontinued
—	ProstaphlinNDA 50118	Apothecon	0	Discontinued
—	ProstaphlinNDA 50194	Apothecon	0	Discontinued
—	Oxacillin SodiumNDA 50195	Apothecon	0	Discontinued
—	Oxacillin SodiumANDA 61457	Apothecon	0	Discontinued
—	BactocillANDA 62241	Glaxosmithkline	0	Discontinued
—	Oxacillin SodiumANDA 62711	Elkins Sinn	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA