Prednisolone Solution
NDC Package 52817-860-08

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

Prednisolone (prednisolone oral) 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 Trupharma, Llc, this product is identified by NDC 52817-860 and is authorized under FDA application ANDA219509.

Identification & Billing

NDC Package Code
52817-860-08
Package Description
240 mL in 1 BOTTLE
Product Code
52817-860
11-Digit Billing Format
52817086008

Clinical Specifications

Proprietary Name
Prednisolone
Non-Proprietary Name
Prednisolone Oral
Substance Name
Prednisolone
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 15 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
Trupharma, Llc
Product Type
Human Prescription Drug
FDA Application #
ANDA219509
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
08-04-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (52817-860). Click a package code to view its specific billing and regulatory data.

52817-860-16
480 mL in 1 BOTTLE

* 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 52817-860-08 identifies a specific commercial package of 240 ml in 1 bottle of Prednisolone, a human prescription drug labeled by Trupharma, Llc. This solution is formulated for oral use and contains prednisolone 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 Trupharma, Llc on August 04, 2026. The current certification is valid through December 31, 2027.

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 Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817086008. 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)
52817-860-08
11-Digit CMS (5-4-2)
52817-0860-08

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