Prednisolone Sodium Phosphate Oral Solution
NDC Package 44523-182-08

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

Package Information

Prednisolone Sodium Phosphate Oral Solution (prednisolone sodium phosphate) solution is prednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. This formulation utilizes a solution delivery system. Marketed by Biocomp Pharma, Inc., this product is identified by NDC 44523-182 and is authorized under FDA application ANDA091396.

Identification & Billing

NDC Package Code
44523-182-08
Package Description
237 mL in 1 BOTTLE
Product Code
44523-182
11-Digit Billing Format
44523018208
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
237 ML
RxNorm Crosswalk
  • RxCUI: 249066 - prednisoLONE sodium phosphate 25 MG in 5 mL Oral Solution
  • RxCUI: 249066 - prednisolone 5 MG/ML Oral Solution
  • RxCUI: 249066 - prednisolone 25 MG (prednisolone sodium phosphate 33.6 MG) per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Prednisolone Sodium Phosphate Oral Solution
Non-Proprietary Name
Prednisolone Sodium Phosphate
Substance Name
Prednisolone Sodium Phosphate
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
PREDNISOLONE SODIUM PHOSPHATE 25 mg/5mL
Pharmacologic Class
Usage Information
Prednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain and allergic-type reactions. This medication is a corticosteroid hormone. Prednisolone may also be used with other medications in hormone disorders.

Regulatory & Marketing

Labeler Name
Biocomp Pharma, Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA091396
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
10-28-2019
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 44523-182-08 identifies a specific commercial package of 237 ml in 1 bottle of Prednisolone Sodium Phosphate Oral Solution, a human prescription drug labeled by Biocomp Pharma, Inc.. This solution is formulated for oral use and contains prednisolone 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 Biocomp Pharma, Inc. on October 28, 2019. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Prednisolone is used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/kidney/intestinal/lung diseases, and immune system disorders. It decreases your immune system's response to various diseases to reduce symptoms such as swelling, pain and allergic-type reactions. This medication is a corticosteroid hormone. Prednisolone may also be used with other medications in hormone disorders.

How is this Biocomp Pharma, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 44523018208. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 237 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)
44523-182-08
11-Digit CMS (5-4-2)
44523-0182-08

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