Polymyxin B Injection, Powder, For Solution
NDC Package 70594-049-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Polymyxin B (polymyxin b sulfate) injection is a medication contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins. This formulation utilizes a injection, powder, for solution delivery system. Marketed by Xellia Pharmaceuticals Usa Llc, this product is identified by NDC 70594-049 and is authorized under FDA application ANDA202766.

Identification & Billing

NDC Package Code
70594-049-01
Package Description
1 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS
Product Code
70594-049
11-Digit Billing Format
70594004901
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
1 EA
RxNorm Crosswalk
  • RxCUI: 204509 - polymyxin B Variable Concentration Multi-Use Injectable Solution
  • RxCUI: 204509 - polymyxin B 250000 UNT/ML Injectable Solution

Clinical Specifications

Proprietary Name
Polymyxin B
Non-Proprietary Name
Polymyxin B Sulfate
Substance Name
Polymyxin B Sulfate
Dosage Form
Injection, Powder, For Solution - A sterile preparation intended for reconstitution to form a solution for parenteral use.
Administration Route
  • Intramuscular - Administration within a muscle.
  • Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
  • Intravenous - Administration within or into a vein or veins.
  • Ophthalmic - Administration to the external eye.
Active Ingredient(s)
POLYMYXIN B SULFATE 500000 [USP'U]/1
Pharmacologic Class
Usage Information
This drug is contraindicated in persons with a prior history of hypersensitivity reactions to polymyxins.

Regulatory & Marketing

Labeler Name
Xellia Pharmaceuticals Usa Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA202766
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-01-2018
Listing Expiration
12-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (70594-049). Click a package code to view its specific billing and regulatory data.

70594-049-02
10 VIAL, GLASS in 1 CARTON / 1 INJECTION, POWDER, FOR SOLUTION in 1 VIAL, GLASS

* 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 70594-049-01 identifies a specific commercial package of 1 vial, glass in 1 carton / 1 injection, powder, for solution in 1 vial, glass of Polymyxin B, a human prescription drug labeled by Xellia Pharmaceuticals Usa Llc. This product is billed for "EA" each discreet unit and contains an estimated amount of 1 billable units per package. This injection, powder, for solution is formulated for intramuscular; intrathecal; intravenous; ophthalmic use and contains polymyxin b sulfate 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 Xellia Pharmaceuticals Usa Llc on October 01, 2018. The current certification is valid through December 31, 2026.

How is this Xellia Pharmaceuticals Usa Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70594004901. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 1 total billable units per package. 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)
70594-049-01
11-Digit CMS (5-4-2)
70594-0049-01

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