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

11-digit billing NDC: 44523018208 · Billing unit: ML · 237 ML per package
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Prednisolone Sodium Phosphate Oral Solution (prednisolone sodium phosphate) solution is prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) is indicated in the following conditions:1. 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 sodium phosphate oral solution (25 mg prednisolone per 5 mL) is indicated in the following conditions:1. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with: seasonal or perennial allergic rhinitis; asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions. 2. Dermatologic Diseases Pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative erythroderma; mycosis fungoides. 3. Edematous States To induce diuresis or remission of proteinuria in nephrotic syndrome in adults with lupus erythematosus and in adults and pediatric populations, with idiopathic nephritic syndrome, without uremia. 4. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. 5. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: ulcerative colitis; regional enteritis. 6. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults; selected cases of secondary thrombocytopenia; acquired (autoimmune) hemolytic anemia; pure red cell aplasia; Diamond-Blackfan anemia. 7. Neoplastic Diseases For the treatment of acute leukemia and aggressive lymphomas in adults and children. 8. Nervous System Acute exacerbations of multiple sclerosis. 9. Ophthalmic Diseases Uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids; temporal arteritis; sympathetic ophthalmia. 10. Respiratory Diseases Symptomatic sarcoidosis; idiopathic eosinophilic pneumonias; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; asthma (as distinct from allergic asthma listed above under “Allergic States”), hypersensitivity pneumonitis, idiopathic pulmonary fibrosis, acute exacerbations of chronic obstructive pulmonary disease (COPD), and Pneumocystis carinii pneumonia (PCP) associated with hypoxemia occurring in an HIV (+) individual who is also under treatment with appropriate anti-PCP antibiotics. Studies support the efficacy of systemic corticosteroids for the treatment of these conditions: allergic bronchopulmonary aspergillosis, idiopathic bronchiolitis obliterans with organizing pneumonia. 11. Rheumatic Disorders As adjunctive therapy for short term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low dose maintenance therapy); ankylosing spondylitis; acute and subacute bursitis; acute nonspecific tenosynovitis; acute gouty arthritis; epicondylitis. For the treatment of systemic lupus erythematosus, dermatomyositis (polymyositis), polymyalgia rheumatica, Sjogren’s syndrome, relapsing polychondritis, and certain cases of vasculitis. 12. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block, tuberculosis with enlarged mediastinal lymph nodes causing respiratory difficulty, and tuberculosis with pleural or pericardial effusion (appropriate antituberculous chemotherapy must be used concurrently when treating any tuberculosis complications); trichinosis with neurologic or myocardial involvement; acute or chronic solid organ rejection (with or without other agents).

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.

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.