Prednisolone Solution
NDC Package 52817-860-08

11-digit billing NDC: 52817086008 · Billing unit: ML · 240 ML per package
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Prednisolone (prednisolone oral) solution is prednisolone Oral Solution, USP is indicated in the following conditions:1. 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
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
RxNorm Crosswalk
  • RxCUI: 283077 - prednisoLONE sodium phosphate 15 MG in 5 mL Oral Solution
  • RxCUI: 283077 - prednisolone 3 MG/ML Oral Solution
  • RxCUI: 283077 - prednisolone 15 MG (as prednisolone sodium phosphate 20.2 MG) per 5 ML Oral Solution
  • RxCUI: 283077 - prednisolone 15 MG per 5 ML Oral Solution

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 Oral Solution, USP is indicated in the following conditions:1. Endocrine DisordersPrimary 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    Nonsuppurative thyroiditis    Hypercalcemia associated with cancer 2. Rheumatic DisordersAs 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    Post-traumatic osteoarthritis    Synovitis of osteoarthritis    Epicondylitis 3. Collagen DiseasesDuring an exacerbation or as maintenance therapy in selected cases of:   Systemic lupus erythematosus    Acute rheumatic carditis 4. Dermatologic Diseases   Pemphigus    Bullous dermatitis herpetiformis    Severe erythema multiforme (Stevens-Johnson syndrome)    Exfoliative dermatitis    Mycosis fungoides    Severe psoriasis    Severe seborrheic dermatitis 5. Allergic StatesControl of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment:   Seasonal or perennial allergic rhinitis    Bronchial asthma    Contact dermatitis    Atopic dermatitis    Serum sickness    Drug hypersensitivity reactions 6. Ophthalmic DiseasesSevere acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as:   Allergic corneal marginal ulcers    Herpes zoster ophthalmicus    Anterior segment inflammation    Diffuse posterior uveitis and choroiditis    Sympathetic ophthalmia    Allergic conjunctivitis    Keratitis    Chorioretinitis    Optic neuritis    Iritis and iridocyclitis 7. Respiratory DiseasesSymptomatic sarcoidosis Loeffler’s syndrome not manageable by other means   Berylliosis    Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate chemotherapy    Aspiration pneumonitis 8. Hematologic Disorders   Idiopathic thrombocytopenic purpura in adults    Secondary thrombocytopenia in adults    Acquired (autoimmune) hemolytic anemia    Erythroblastopenia (RBC anemia)    Congenital (erythroid) hypoplastic anemia 9. Neoplastic DiseasesFor palliative management of:   Acute leukemia of childhood    Leukemias and lymphomas in adults 10. Edematous StatesTo induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.11. Gastrointestinal DiseasesTo tide the patient over a critical period of the disease in:   Ulcerative colitis    Regional enteritis 12. MiscellaneousTuberculous meningitis with subarachnoid block or impending block used concurrently with appropriate antituberculous chemotherapy. Trichinosis with neurologic or myocardial involvement.In addition to the above indications prednisolone oral solution is indicated for systemic dermatomyositis (polymyositis).

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.

How is this Trupharma, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52817086008. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 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)
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.