Dicloxacillin Sodium

Sold as Pathocil, Dynapen. Every FDA application for this active ingredient: 3 branded and 6 generic.

As of Nov 15, 2026, FDA lists 9 applications for Dicloxacillin Sodium (sold as Pathocil, Dynapen), first approved Apr 22, 1968, with 1 new use approved and 0 published complete response letters.

First approved: Apr 22, 1968
Applications: 9
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $1.0M

Medicare Spending

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

Product	Part	Spending, 2025	Change	Beneficiaries
Dicloxacillin Sodium	Part D	$1.0M	+5%	17,430

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

DICLOXACILLIN 250 MG CAPSULE: $0.594 per unitGeneric · -1% in a year
DICLOXACILLIN 500 MG CAPSULE: $0.915 per unitGeneric · -7% in a year

Clinical Trials

5 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
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
Effect of Single vs Multiple Prophylactic Antibiotic Doses on PJI Following Primary THA in Patients With a FractureFracture of Hip, Total Hip Arthroplasty · Soren Overgaard	Not applicable	Active, not recruiting	Sep 7, 2022
Oral Antimicrobial Treatment vs. Outpatient Parenteral for Infective EndocarditisEndocarditis Infective · Fundacion Clinic per a la Recerca Biomédica	Phase 4	Recruiting	Jun 1, 2022
Determinants of Warfarin MetabolismHealthy · Hadassah Medical Organization	Not applicable	Recruiting	Sep 13, 2005

Applications

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


Apr 22, 1968	PathocilNDA 50092	Wyeth Ayerst	29	Discontinued
May 9, 1968	PathocilNDA 50011	Wyeth Ayerst	29	Discontinued
Apr 1, 1971	Dicloxacillin SodiumANDA 61454	Chartwell Rx	6	Discontinued
Apr 1, 1971	Dicloxacillin SodiumANDA 61455	Apothecon	1	Discontinued
Dec 31, 1979	DycillANDA 62238	Glaxosmithkline	2	Discontinued
Jun 3, 1982	Dicloxacillin SodiumANDA 62286	Chartwell Rx	14	Marketed
Sep 23, 2022	Dicloxacillin SodiumANDA 216845	Aurobindo Pharma	0	Marketed
—	DycillANDA 60254	Glaxosmithkline	0	Discontinued
—	DynapenNDA 50337	Apothecon	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