Prednisolone Sodium Phosphate Solution
NDC Package 0121-1100-04

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 Pai Holdings, Llc Dba Pai Pharma, this product is identified by NDC 0121-1100 and is authorized under FDA application NDA019157.

Identification & Billing

NDC Package Code
0121-1100-04
Package Description
5 mL in 1 BOTTLE
Product Code
0121-1100
11-Digit Billing Format
00121110004
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
5 ML
RxNorm Crosswalk
  • RxCUI: 312614 - prednisoLONE sodium phosphate 5 MG in 5 mL Oral Solution
  • RxCUI: 312614 - prednisolone 1 MG/ML Oral Solution
  • RxCUI: 312614 - prednisolone 5 MG (as prednisolone sodium phosphate 6.7 MG) per 5 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 5 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
Pai Holdings, Llc Dba Pai Pharma
Product Type
Human Prescription Drug
FDA Application #
NDA019157
Marketing Category
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date
06-26-2026
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0121-1100-04 identifies a specific commercial package of 5 ml in 1 bottle of Prednisolone Sodium Phosphate, a human prescription drug labeled by Pai Holdings, Llc Dba Pai Pharma. 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 Pai Holdings, Llc Dba Pai Pharma on June 26, 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 Pai Holdings, Llc Dba Pai Pharma product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00121110004. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 5 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 (4-4-2)
0121-1100-04
11-Digit CMS (5-4-2)
00121-1100-04

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