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Prednisolone Sodium Phosphate Oral Solution 25 mg/5mL Solution, 237 mL — NDC 44523-182-08 (Billing 44523-0182-08)

by BioComp Pharma, Inc. · 237 mL in 1 BOTTLE

This is a package of 237 mL of Prednisolone Sodium Phosphate Oral Solution 25 mg/5mL Solution from BioComp Pharma, Inc., marketed since Oct 2019 and currently FDA-listed; retail pharmacies pay about $0.7881 per mL (NADAC). It is this product's only package size.

NDC 44523-0182-08
🏷️ FDA NDC (as labeled) 44523-182-08 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 44523-182-08
Product NDC 44523-182
11-digit billing NDC 44523018208
NCPDP billing unit ML — per mL (volume)
RxCUI 249066
UNII IV021NXA9J
UPC 0344523182080
Application # ANDA091396
SPL Set ID 95208441-1700-5d3f-e053-2a95a90a7da2
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-10-28
Route ORAL
Dosage form SOLUTION
Substance PREDNISOLONE SODIUM PHOSPHATE
TE code (Orange Book) AA · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 22100040202025
GPI class prednisoLONE Sodium Phosphate
GCN Seq No 041424
GCN 93945
HICL code 002871
Ingredient (HICL) Prednisolone Sodium Phosphate
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name PREDNISOLONE SOD PH 25 MG/5 ML
FDB brand name Prednisolone Sodium Phosphate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 041424
  • GCN: 93945
  • GPI-14 (Medi-Span): 22100040202025
  • HICL (First Databank): 002871
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 249066
Why two NDCs? The FDA registers this code as 44523-182-08 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 44523-0182-08. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids acting locally, Corticosteroids
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name PREDNISOLONE SOD PH 25 MG/5 ML Ingredient Prednisolone Sodium Phosphate
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation and an overactive immune system. Depending on the product, that can mean allergic conditions, skin diseases, hormone problems, ulcerative colitis or Crohn's d...
  • Follow your prescriber's directions. The dissolving tablets should be taken with food, and you should not split them. For eye suspensions, shake the bottle well first. Don't stop e...
  • Some people notice fluid retention, higher blood sugar or blood pressure, mood changes, trouble sleeping, nausea, and more appetite with weight gain. Call your doctor for signs of...
  • Often yes, but check with me first. Warfarin, diabetes medicines, aspirin or NSAIDs, water pills, digoxin, cyclosporine, and certain seizure and antibiotic medicines can interact....
📖 Read our full Prednisolone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Prednisolone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Prednisolone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $0.788 $186.78 / 237 ml
Medicaid paysCMS SDUD · 12 mo $1.21 $287.69 / 237 ml
Medicare drug plans payPart D · Q2 2026 $0.8917 $211.33 / 237 ml
NADAC price history (per mL) — tap or hover for the price & month
Jul 2025 $0.788 $0.788
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
44523-0182-08 You're viewing this Main listing 237 mL in 1 BOTTLE 2019-10-28 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prednisolone Sodium Phosphate 25 mg/5mL 42799-0816-01 Edenbridge 237 ml $0.788 AA Availability likely —
Prednisolone Sodium Phosphate Oral Solution 25 mg/5mLthis 44523-0182-08 BioComp 237 ml $0.788 AA Availability likely —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2019
On the market since
Oct 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

FlavorGrape
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerBioComp Pharma, Inc.
Application holderMISSION PHARMACAL CO
FDA applicationANDA091396 (ANDA)
Labeler code44523
First marketedOct 2019
Product typeHuman Prescription Drug
Portfolio28 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE 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).

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The initial dosage of prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) may vary from 1 mL to 12 mL (5 to 60 mg prednisolone base) per day depending on the specific disease entity being treated. In situations of less severity, lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted.

If after a reasonable period of time, there is a lack of satisfactory clinical response, prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) should be discontinued and the patient placed on other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) for a period of time consistent with the patient’s condition.

If after long term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. In the treatment of acute exacerbations of multiple sclerosis, daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day or 4 to 8 mg dexamethasone every other day for one month have been shown to be effective. In pediatric patients, the initial dose of prednisolone sodium phosphate oral solution (25 mg prednisolone per 5 mL) may vary depending on the specific disease entity being treated.

The range of initial doses is 0.14 to 2 mg/kg/day in three or four divided doses (4 to 60 mg/m 2 bsa/day). The standard regimen used to treat nephrotic syndrome in pediatric patients is 60 mg/m2/day given in three divided doses for 4 weeks, followed by 4 weeks of single dose alternate-day therapy at 40 mg/m 2 /day. The National Heart, Lung, and Blood Institute (NHLBI) recommended dosing for systemic prednisone, prednisolone or methylprednisolone in children whose asthma is uncontrolled by inhaled corticosteroids and long-acting bronchodilators is 1-2 mg/kg/day in single or divided doses.

It is further recommended that short course, or “burst” therapy, be continued until a child achieves a peak expiratory flow rate of 80% of his or her personal best or symptoms resolve. This usually requires 3 to 10 days of treatment, although it can take longer. There is no evidence that tapering the dose after improvement will prevent a relapse.

For the purpose of comparison, 5 mL of prednisolone sodium phosphate oral solution (33.6 mg prednisolone sodium phosphate) is equivalent to the following milligram dosage of the various glucocorticoids: These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered. image

⛔ Contraindications 13 words ▾

CONTRAINDICATIONS Systemic fungal infections. Hypersensitivity to the drug or any of its components.

⚠️ Warnings ~2 min read ▾

WARNINGS General: In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection: Corticosteroids, including prednisolone sodium phosphate oral solution, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: • Reduce resistance to new infections • Exacerbate existing infections • Increase the risk of disseminated infections • Increase the risk of reactivation or exacerbation of latent infections • Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider prednisolone sodium phosphate oral solution withdrawal or dosage reduction as needed. Tuberculosis: If prednisolone sodium phosphate oral solution is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation. During prolonged prednisolone sodium phosphate oral solution therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections: Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including prednisolone sodium phosphate oral solution.

In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: • If a prednisolone sodium phosphate oral solution-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. • If a prednisolone sodium phosphate oral solution-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation: Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including prednisolone sodium phosphate oral solution. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with prednisolone sodium phosphate oral solution.

For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections: Corticosteroids, including prednisolone sodium phosphate oral solution, may exacerbate systemic fungal infections; therefore, avoid prednisolone sodium phosphate oral solution use in the presence of such infections unless prednisolone sodium phosphate oral solution is needed to control drug reactions.

For patients on chronic prednisolone sodium phosphate oral solution therapy who develop systemic fungal infections, prednisolone sodium phosphate oral solution withdrawal or dosage reduction is recommended. Amebiasis: Corticosteroids, including prednisolone sodium phosphate oral solution, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating prednisolone sodium phosphate oral solution in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation: Corticosteroids, including prednisolone sodium phosphate oral solution, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients,…

🤒 Adverse Reactions 212 words ▾

ADVERSE REACTIONS (listed alphabetically under each subsection) Cardiovascular: Hypertrophic cardiomyopathy in premature infants. Dermatologic: Facial erythema; increased sweating; impaired wound healing; may suppress reactions to skin tests; petechiae and ecchymoses; thin fragile skin; urticaria; edema. Endocrine: Decreased carbohydrate tolerance; development of cushingoid state; hirsutism; increased requirements for insulin or oral hypoglycemic agents in diabetic patients; manifestations of latent diabetes mellitus; menstrual irregularities; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children.

Fluid and Electrolyte Disturbances : Congestive heart failure in susceptible patients; fluid retention; hypertension; hypokalemic alkalosis; potassium loss; sodium retention. Gastrointestinal: Abdominal distention; elevation in serum liver enzyme levels (usually reversible upon discontinuation); pancreatitis; peptic ulcer with possible perforation and hemorrhage; ulcerative esophagitis. Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads; loss of muscle mass; muscle weakness; osteoporosis; pathologic fracture of long bones; steroid myopathy; tendon rupture; vertebral compression fractures. Neurological: Convulsions; headache; increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment; psychic disorders; vertigo. Ophthalmic: Exophthalmos; glaucoma; increased intraocular pressure; posterior subcapsular cataracts.

Other: Increased appetite; malaise; nausea; weight gain. To report SUSPECTED ADVERSE REACTIONS, contact BioComp Pharma®, Inc. at 1-866-762-2365 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🤰 Pregnancy 1 words ▾

Pregnancy

🧒 Pediatric Use ~1 min read ▾

Pediatric Use The efficacy and safety of prednisolone in the pediatric population are based on the well-established course of effect of corticosteroids which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (>2 years of age), and aggressive lymphomas and leukemias (>1 month of age). However, some of these conclusions and other indications for pediatric use of corticosteroid, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of prednisolone in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Children who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity.

This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of HPA axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in children than some commonly used tests of HPA axis function. The linear growth of children treated with corticosteroids by any route should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of other treatment alternatives.

In order to minimize the potential growth effects of corticosteroids, children should be titrated to the lowest effective dose.

🧓 Geriatric Use ~2 min read ▾

Geriatric Use Clinical studies of prednisolone sodium phosphate oral solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience with prednisolone sodium phosphate has not identified differences in responses between the elderly and younger patients. However, the incidence of corticosteroid-induced side effects may be increased in geriatric patients and appear to be dose-related.

Osteoporosis is the most frequently encountered complication, which occurs at a higher incidence rate in corticosteroid-treated geriatric patients as compared to younger populations and in age-matched controls. Losses of bone mineral density appear to be greatest early on in the course of treatment and may recover over time after steroid withdrawal or use of lower doses (i.e., ≤5 mg/day). Prednisolone doses of 7.5 mg/day or higher have been associated with an increased relative risk of both vertebral and nonvertebral fractures, even in the presence of higher bone density compared to patients with involutional osteoporosis.

Routine screening of geriatric patients, including regular assessments of bone mineral density and institution of fracture prevention strategies along with regular review of prednisolone sodium phosphate indication should be undertaken to minimize complications and keep the dose at the lowest acceptable level. Co-administration of bisphosphonates has been shown to retard the rate of bone loss in corticosteroidtreated males and postmenopausal females, and these agents are recommended in the prevention and treatment of corticosteroid-induced osteoporosis.

It has been reported that equivalent weight-based doses yield higher total and unbound prednisolone plasma concentrations and reduced renal and non-renal clearance in elderly patients compared to younger populations. However, it is not clear whether dosing reductions would be necessary in elderly patients, since these pharmacokinetic alterations may be offset by age-related differences in responsiveness of target organs and/ or less pronounced suppression of adrenal release of cortisol. Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of communicant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function (see CLINICAL PHARMACOLOGY ).

🆘 Overdosage 148 words ▾

OVERDOSAGE The effects of accidental ingestion of large quantities of prednisolone over a very short period of time have not been reported, but prolonged use of the drug can produce mental symptoms, moon face, abnormal fat deposits, fluid retention, excessive appetite, weight gain, hypertrichosis, acne, striae, ecchymosis, increased sweating, pigmentation, dry scaly skin, thinning scalp hair, increased blood pressure, tachycardia, thrombophlebitis, decreased resistance to infection, negative nitrogen balance with delayed bone and wound healing, headache, weakness, menstrual disorders, accentuated menopausal symptoms, neuropathy, fractures, osteoporosis, peptic ulcer, decreased glucose tolerance, hypokalemia, and adrenal insufficiency.

Hepatomegaly and abdominal distention have been observed in children. Treatment of acute overdosage is by immediate gastric lavage or emesis followed by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of prednisolone may be reduced only temporarily, or alternate day treatment may be introduced.

🧬 Clinical Pharmacology ~2 min read ▾

CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Prednisolone is a synthetic adrenocortical steroid drug with predominantly glucocorticoid properties.

Some of these properties reproduce the physiological actions of endogenous glucocorticosteroids, but others do not necessarily reflect any of the adrenal hormones’ normal functions; they are seen only after administration of large therapeutic doses of the drug. The pharmacological effects of prednisolone which are due to its glucocorticoid properties include: promotion of gluconeogenesis; increased deposition of glycogen in the liver; inhibition of the utilization of glucose; anti-insulin activity; increased catabolism of protein; increased lipolysis; stimulation of fat synthesis and storage; increased glomerular filtration rate and resulting increase in urinary excretion of urate (creatinine excretion remains unchanged); and increased calcium excretion.

Depressed production of eosinophils and lymphocytes occurs, but erythropoiesis and production of polymorphonuclear leukocytes are stimulated. Inflammatory processes (edema, fibrin deposition, capillary dilatation, migration of leukocytes and phagocytosis) and the later stages of wound healing (capillary proliferation, deposition of collagen, cicatrization) are inhibited. Prednisolone can stimulate secretion of various components of gastric juice.

Suppression of the production of corticotropin may lead to suppression of endogenous corticosteroids. Prednisolone has slight mineralocorticoid activity, whereby entry of sodium into cells and loss of intracellular potassium is stimulated. This is particularly evident in the kidney, where rapid ion exchange leads to sodium retention and hypertension.

Prednisolone is rapidly and well absorbed from the gastrointestinal tract following oral administration. Prednisolone sodium phosphate oral solution produces a 14% higher peak plasma level of prednisolone which occurs 20% faster than that seen with tablets. Prednisolone is 70-90% protein-bound in the plasma, and it is eliminated from the plasma with a half-life of 2 to 4 hours.

It is metabolized mainly in the liver and excreted in the urine as sulfate and glucuronide conjugates. The systemic availability, metabolism and elimination of prednisolone after administration of single weight-based doses (0.8 mg/kg) of intravenous (IV) prednisolone and oral prednisone were reported in a small study of 19 young (23 to 34 years) and 12 elderly (65 to 89 years) subjects. Results showed that the systemic availability of total and unbound prednisolone, as well as interconversion between prednisolone and prednisone were independent of age.

The mean unbound fraction of prednisolone was higher, and steady-state volume of distribution (Vss) of unbound prednisolone was reduced in elderly patients. Plasma prednisolone concentrations were higher in elderly subjects, and the higher AUCs of total and unbound prednisolone were most likely reflective of an impaired metabolic clearance, evidenced by reduced fractional urinary clearance of 6ß -hydroxyprednisolone. Despite these findings of higher total and unbound prednisolone concentrations, elderly subjects had higher AUCs of cortisol, suggesting that the elderly population is less sensitive to suppression of endogenous cortisol or their capacity for hepatic inactivation of cortisol is diminished.

📦 How Supplied / Storage and Handling 137 words ▾

HOW SUPPLIED Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a pale yellow, grape flavored solution. NDC 44523-182-08 8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2° to 8°C (36° to 46°F).

Keep tightly closed and out of the reach of children. Image Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a pale yellow, grape flavored solution. NDC 44523-182-08 8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP.

Store refrigerated, 2° to 8°C (36° to 46°F). Keep tightly closed and out of the reach of children.

📦 Storage and Handling 67 words ▾

Each 5 mL (teaspoonful) of Prednisolone Sodium Phosphate Oral Solution contains 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a pale yellow, grape flavored solution. NDC 44523-182-08 8 fl oz (237 mL) bottle Dispense in tight, light-resistant glass or PET plastic containers as defined in the USP. Store refrigerated, 2° to 8°C (36° to 46°F). Keep tightly closed and out of the reach of children.

📋 Description 144 words ▾

DESCRIPTION Prednisolone sodium phosphate oral solution is a dye free, pale to light yellow solution. Each 5 mL (teaspoonful) of prednisolone sodium phosphate oral solution contains 33.6 mg prednisolone sodium phosphate (25 mg prednisolone base) in a palatable, aqueous vehicle. Prednisolone sodium phosphate oral solution also contains antibitter mask, corn syrup, edetate disodium, glycerin, grape flavor, hydroxyethylcellulose, methylparaben, potassium phosphate dibasic, potassium phosphate monobasic, purified water, and sodium saccharin.

Prednisolone sodium phosphate occurs as white or slightly yellow, friable granules or powder. It is freely soluble in water; soluble in methanol; slightly soluble in alcohol and in chloroform; and very slightly soluble in acetone and in dioxane. The chemical name of prednisolone sodium phosphate is pregna-1,4-diene-3,20- dione,11,17-dihydroxy- 21-(phosphonooxy)- disodium salt, (11ß)-.

The empirical formula is C 21 H 27 Na 2 O 8 P; the molecular weight is 484.39. Its chemical structure is: structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5K
Units reimbursed last 4 qtrs
167.2K
Gross reimbursed last 4 qtrs
$203K
Avg / prescription
$40.29
Avg / unit
$1.2139
Latest quarter Q1 2026
1.2KRx
Medicaid pays / mL
$1.2139
gross reimbursed
vs
NADAC / mL
$0.7881
acquisition cost
=
Spread
+$0.4258
+54% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
47% FFS 53% MCO
Fee-for-service · 2,380 Rx Managed care · 2,659 Rx
State Medicaid map
Alaska: 1,351 units · 184 per 100k residents AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: 818 units · 8.1 per 100k residents MI New York: 1,097 units · 5.6 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 763 units · 23.8 per 100k residents IA Illinois: 3,131 units · 25.0 per 100k residents IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 2,522 units · 19.5 per 100k residents PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 378 units · 1.0 per 100k residents CA Utah: no data reported UT Colorado: 1,569 units · 26.7 per 100k residents CO Nebraska: no data reported NE Missouri: 2,944 units · 47.5 per 100k residents MO Kentucky: 6,023 units · 133 per 100k residents KY West Virginia: no data reported WV Virginia: 1,936 units · 22.2 per 100k residents VA Maryland: 1,211 units · 19.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: 1,982 units · 26.7 per 100k residents AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 8,322 units · 76.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: 6,161 units · 152 per 100k residents OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 64,391 units · 1,261 per 100k residents AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 56,851 units · 186 per 100k residents TX Florida: 5,779 units · 25.6 per 100k residents FL
Units reimbursed · per 100k residents
1.01,261
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Alabama 1,261 /100k
2 Texas 186 /100k
3 Alaska 184 /100k
4 Oklahoma 152 /100k
5 Kentucky 133 /100k
6 North Carolina 76.8 /100k
7 Missouri 47.5 /100k
8 Colorado 26.7 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Prednisolone Sodium Phosphate (matched by generic name) — the program that covers self-administered drugs. 6 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Prednisolone Sodium Phosphate. CMS lists 3 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$315.5K
Claims incl. refills
10.8K
Beneficiaries
9.2K
Spend / beneficiary
$34.22
Spend / claim
$29.32
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 44523-0120-16 · BioComp 44523-0410-01 · Biocomp →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.