Drugplain

Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g

Bacitracin Zinc and Polymyxin B Sulfate · OINTMENT · NuCare Pharmaceuticals,Inc.

2 Recalls on Record
Plain English

Bacitracin Zinc and Polymyxin B Sulfate is a ointment containing bacitracin zinc and polymyxin b sulfate at 500 [USP'U]/g, taken ophthalmic. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name
Bacitracin Zinc and Polymyxin B Sulfate
Generic Name
Bacitracin Zinc and Polymyxin B Sulfate
NDC Code (Product)
68071-5267
Manufacturer
NuCare Pharmaceuticals,Inc.
Strength
500 [USP'U]/g
Dosage Form
OINTMENT
Route
OPHTHALMIC
Marketing Status
Application #
ANDA064046
Marketing Start
04/25/2008

Recall History

2 Recalls on Record
Class II07/02/2019

Altaire Pharmaceuticals, Inc.

Lack of Assurance of Sterility

CompletedVoluntary: Firm initiated
Class II04/26/2023

Akorn, Inc.

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

headache12 reports
off label use12 reports
weight increased12 reports
pain11 reports
pruritus11 reports
wheezing11 reports
dyspepsia10 reports
hypersensitivity10 reports
rash10 reports
weight decreased10 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE For the treatment of superficial ocular infections involving the conjunctiva and/or cornea caused by organisms susceptible to bacitracin zinc and polymyxin B sulfate.

Dosage & Administration

DOSAGE AND ADMINISTRATION Apply the ointment every 3 or 4 hours for 7 to 10 days, depending on the severity of the infection. FOR OPHTHALMIC USE ONLY

Warnings

WARNINGS Ophthalmic ointments may retard corneal healing.

Contraindications

CONTRAINDICATIONS This product is contraindicated in those individuals who have shown hypersensitivity to any of its components.

Adverse Reactions

ADVERSE REACTIONS To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Frequently Asked Questions

What is Bacitracin Zinc and Polymyxin B Sulfate used for?

Bacitracin Zinc and Polymyxin B Sulfate contains Bacitracin Zinc and Polymyxin B Sulfate. It is a ointment taken ophthalmic. Consult your doctor for specific uses.

Is Bacitracin Zinc and Polymyxin B Sulfate a controlled substance?

Bacitracin Zinc and Polymyxin B Sulfate is not classified as a controlled substance by the DEA.

What is the generic name for Bacitracin Zinc and Polymyxin B Sulfate?

The generic name for Bacitracin Zinc and Polymyxin B Sulfate is Bacitracin Zinc and Polymyxin B Sulfate. There are 8 other brand versions of Bacitracin Zinc and Polymyxin B Sulfate.

What is the NDC code for Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g?

The NDC (National Drug Code) for Bacitracin Zinc and Polymyxin B Sulfate 500 [USP'U]/g is 68071-5267, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-5267

Package NDC

68071-5267-3

Other Bacitracin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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