Nafcillin Injection, Powder, For Solution
NDC Package 83270-316-10

11-digit billing NDC: 83270031610
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Nafcillin injection is nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Onesource Specialty Pharma Limited, this product is identified by NDC 83270-316 and is authorized under FDA application ANDA203830.

Identification & Billing

NDC Package Code
83270-316-10
Package Description
10 INJECTION, POWDER, FOR SOLUTION in 1 CARTON
Product Code
83270-316
11-Digit Billing Format
83270031610

Clinical Specifications

Proprietary Name
Nafcillin
Non-Proprietary Name
Nafcillin
Substance Name
Nafcillin Sodium
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s)
NAFCILLIN SODIUM 10 g/1
Pharmacologic Class
Usage Information
Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see   CLINICAL PHARMACOLOGY-Susceptibility Test Methods). Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to a methicillin-resistant Staphylococcussp., therapy with Nafcillin for Injection should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection and other antibacterial drugs, Nafcillin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Regulatory & Marketing

Labeler Name
Onesource Specialty Pharma Limited
Product Type
Human Prescription Drug
FDA Application #
ANDA203830
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-12-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83270-316-10 identifies a specific commercial package of 10 injection, powder, for solution in 1 carton of Nafcillin, a human prescription drug labeled by Onesource Specialty Pharma Limited. This injection, powder, for solution is formulated for intravenous use and contains nafcillin sodium as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Onesource Specialty Pharma Limited on October 12, 2026. The current certification is valid through December 31, 2027.

How is this Onesource Specialty Pharma Limited product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83270031610. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
83270-316-10
11-Digit CMS (5-4-2)
83270-0316-10

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.