Elliotts B Injection
NDC Package 55792-007-10

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

Package Information

Elliotts B (sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate) injection is elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma. This formulation utilizes a injection delivery system. Marketed by Lukare Medical, Llc, this product is identified by NDC 55792-007 and is authorized under FDA application NDA020577.

Identification & Billing

NDC Package Code
55792-007-10
Package Description
10 AMPULE in 1 BOX / 10 mL in 1 AMPULE (55792-007-01)
Product Code
55792-007
11-Digit Billing Format
55792000710
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.

Clinical Specifications

Proprietary Name
Elliotts B
Non-Proprietary Name
Sodium Cation, Sodium Bicarbonate, Anhydrous Dextrose, Magnesium Sulfate, Potassium Chloride, Calcium Chloride, Sodium Phosphate
Substance Name
Anhydrous Dextrose; Calcium Chloride; Magnesium Sulfate, Unspecified Form; Potassium Chloride; Sodium Bicarbonate; Sodium Chloride; Sodium Phosphate
Dosage Form
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route
Intrathecal - Administration within the cerebrospinal fluid at any level of the cerebrospinal axis, including injection into the cerebral ventricles.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Elliotts B Solution is indicated as a diluent for the intrathecal administration of methotrexate sodium and cytarabine for the prevention or treatment of meningeal leukemia or lymphocytic lymphoma.

Regulatory & Marketing

Labeler Name
Lukare Medical, Llc
Product Type
Human Prescription Drug
FDA Application #
NDA020577
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-04-2013
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 55792-007-10 identifies a specific commercial package of 10 ampule in 1 box / 10 ml in 1 ampule (55792-007-01) of Elliotts B, a human prescription drug labeled by Lukare Medical, Llc. This injection is formulated for intrathecal use and contains anhydrous dextrose; calcium chloride; magnesium sulfate, unspecified form; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate 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 Lukare Medical, Llc on June 04, 2013. The current certification is valid through December 31, 2026.

How is this Lukare Medical, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55792000710. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
55792-007-10
11-Digit CMS (5-4-2)
55792-0007-10

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