Bactocill In Plastic Container

Treats infections caused by penicillinase producing staphylococci. NDA 50640, held by Baxter Hlthcare. Oxacillin Sodium.

As of Nov 13, 2026, NDA 50640 (Bactocill In Plastic Container), held by Baxter Hlthcare, was first approved by FDA on Oct 26, 1989, with 14 approved supplements and 0 published complete response letters.

First approved: Oct 26, 1989
Review: Standard
Supplements approved: 14
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE 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. (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 15 submissions below

Date	Submission	Status	Documents
Oct 26, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Bactocill In Plastic ContainerEQ 20MG BASE/ML · injectable;injection	Oxacillin Sodium	DiscontinuedReference drug
Bactocill In Plastic ContainerEQ 40MG BASE/ML · injectable;injection	Oxacillin Sodium	RxReference drug

All 15 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Aug 31, 2026	Supplement 24Labeling · Standard review	Approved	Letter Label
Feb 24, 2017	Supplement 20Labeling · Standard review	Approved	Letter Label
Jan 6, 2015	Supplement 17Labeling · Standard review	Approved	Letter Label
Feb 19, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 19, 2013	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 21, 2012	Supplement 15Labeling · Standard review	Approved	Label Letter
Oct 13, 2011	Supplement 11Labeling · Standard review	Approved	Label Letter
Apr 17, 2008	Supplement 10Labeling · Standard review	Approved	Label Letter
Mar 17, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Aug 23, 2002	Supplement 6Labeling · Standard review	Approved	Letter
Jun 12, 2000	Supplement 4Labeling · Standard review	Approved	None posted
Feb 2, 1999	Supplement 5Manufacturing · Standard review	Approved	None posted
Apr 5, 1993	Supplement 2Manufacturing · Standard review	Approved	None posted
Dec 19, 1991	Supplement 1Labeling	Approved	None posted
Oct 26, 1989	Original applicationNew dosage form · Standard review	Approved	None posted

Identifiers

Application: NDA 50640
Drugs@FDA: Overview at FDA
Company: Baxter Healthcare

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters