Prednisolone Sodium Phosphate Solution
NDC Package 42799-816-01

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 solution is prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. This formulation utilizes a solution delivery system. Marketed by Edenbridge Pharmaceuticals Llc., this product is identified by NDC 42799-816 and is authorized under FDA application ANDA203559.

Identification & Billing

NDC Package Code
42799-816-01
Package Description
237 mL in 1 BOTTLE, PLASTIC
Product Code
42799-816
11-Digit Billing Format
42799081601
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
  • RxCUI: 283077 - prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution
  • RxCUI: 283077 - prednisolone 3 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Prednisolone Sodium Phosphate
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 a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

Regulatory & Marketing

Labeler Name
Edenbridge Pharmaceuticals Llc.
Product Type
Human Prescription Drug
FDA Application #
ANDA203559
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
05-01-2023
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 42799-816-01 identifies a specific commercial package of 237 ml in 1 bottle, plastic of Prednisolone Sodium Phosphate, a human prescription drug labeled by Edenbridge Pharmaceuticals Llc.. 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 Edenbridge Pharmaceuticals Llc. on May 01, 2023. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

Prednisolone is a man-made form of a natural substance (corticosteroid hormone) made by the adrenal gland. It is used to treat conditions such as arthritis, blood problems, immune system disorders, skin and eye conditions, breathing problems, cancer, and severe allergies. It decreases your immune system's response to various diseases to reduce symptoms such as pain, swelling and allergic-type reactions.

How is this Edenbridge Pharmaceuticals Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 42799081601. 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)
42799-816-01
11-Digit CMS (5-4-2)
42799-0816-01

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