PrednisoLONE 15 mg/5mL Syrup, 480 mL
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- Prednisolone is a steroid that calms inflammation and dials down an overactive immune system. Depending on what you're being treated for — whether that's an asthma flare, a skin co...
- Why has my doctor prescribed prednisolone — what is it actually doing?
- Please don't stop on your own — this is one of the most important things to know about prednisolone. When you take it for more than a short time, your adrenal glands slow down thei...
- Can I stop taking prednisolone when I start feeling better?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Prednisolone — tap one for details:
Prednisolone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 8SKN0B0MIM
Benzoic acid is a naturally occurring organic acid used as a preservative in medicines and foods. It helps prevent bacterial and fungal growth to extend shelf life and maintain product stability.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII PDC6A3C0OX
Glycerin is a clear, thick liquid derived from plant oils or fats. It acts as a humectant to retain moisture, a sweetener, and a solvent in medications.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII SB8ZUX40TY
Saccharin sodium is an artificial sweetener made from saccharin salt. It's added to medicines to improve taste, especially in liquid formulations for children or bitter drugs.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII C151H8M554
A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
12 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 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 system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.615 | $295.20 / 480 ml |
| Medicaid paysCMS SDUD · 12 mo | $0.6803 | $326.54 / 480 ml |
| Medicare drug plans payPart D · Q2 2026 | $0.5590 | $268.32 / 480 ml |
| Medicare Part B allowsASP · J7510 | $0.777 / J7510 unit | — |
Where does this data come from?
🧾 Billing & reimbursement
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Prednisolone Sodium Phosphate 15 mg/5mL 00121-0759-08 | PAI | 237 ml | $0.105 | AA | Availability likely | save 83% |
| Prednisolone Sodium Phosphate 15 mg/5mL 42799-0815-01 | Edenbridge | 237 ml | $0.105 | AA | Availability likely | save 83% |
| Prednisolone Sodium Phosphate 15 mg/5mL 69238-2122-09 | Amneal | 237 ml | $0.105 | AA | Availability likely | save 83% |
| Prednisolone 15 mg/5mL 00121-0885-08 | PAI | 240 ml | $0.574 | AA | Availability likely | save 7% |
| Prednisolone 15 mg/5mL 23155-0927-51 | Heritage | 240 ml | $0.574 | AA | Availability likely | save 7% |
| Prednisolone 15 mg/5mL 62135-0250-37 | Chartwell | 240 ml | $0.574 | AA | Availability likely | save 7% |
| PrednisoLONE 15 mg/5mLthis 00527-5406-70 | Lannett | 480 ml | $0.615 | AA | Availability likely | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 00121-4759-50 | PAI | 10 cups | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 17856-0815-01 | ATLANTIC | 72 cups | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 17856-8815-01 | Atlantic | 50 cups | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 50090-1582-00 | A-S | 237 ml | — | AA | FDA listed | — |
| Prednisolone 15 mg/5mL 50090-7115-00 | A-S | 2 bottles | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 63187-0215-64 | Proficient | 240 ml | — | AA | FDA listed | — |
| Prednisolone 15 mg/5mL 67296-1656-06 | RedPharm | 60 ml | — | — | Discontinued | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 67296-2134-06 | Redpharm | 60 ml | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 68788-4046-02 | Preferred | 237 ml | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 68788-7708-02 | Preferred | 237 ml | — | AA | FDA listed | — |
| Prednisolone 15 mg/5mL 68999-0250-24 | Chartwell | 10 cups | — | AA | FDA listed | — |
| Prednisolone Sodium Phosphate 15 mg/5mL 70518-4524-00 | REMEDYREPACK | 2 cups | — | AA | FDA listed | — |
| prednisoLONE sodium phosphate 15 mg/5mL 81033-0021-54 | Kesin | 50 cups | — | AA | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 00527-5406-68 | 240 mL in 1 BOTTLE (0527-5406-68) | $0.5740 / mL | $137.76 | 2007-09-21 | Active |
| 00527-5406-70 You're viewing this | 480 mL in 1 BOTTLE (0527-5406-70) | $0.6150 / mL | $295.19 | 2007-09-21 | Active |
You're viewing the largest of 2 pack sizes for this product.
Per mL, this pack runs about 7% above the cheapest pack (240 mL, $0.5740 vs $0.6150 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 81% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 00527-5406-70?
What is the difference between NDC 00527-5406-70 and NDC 00527-5406-68?
What NDC number is used to bill for this package of PrednisoLONE 15 mg/5mL Syrup?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Prednisolone Syrup (Prednisolone Oral Solution, USP) is indicated in the following conditions: 1. 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.
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 Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3. Collagen Diseases During 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 States Control 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 Diseases Severe 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 Diseases Symptomatic 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 Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10.
Edematous States To 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 Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.
Miscellaneous Tuberculous 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 Syrup (Prednisolone Oral Solution, USP) is indicated for systemic dermatomyositis (polymyositis).
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION Dosage of Prednisolone Syrup (Prednisolone Oral Solution, USP) should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight. Hormone therapy is an adjunct to and not a replacement for conventional therapy.
Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.
Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease. The initial dosage of Prednisolone Syrup (Prednisolone Oral Solution, USP) may vary from 5 mg to 60 mg 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 Syrup (Prednisolone Oral Solution, USP) should be discontinued and the patient transferred to 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 Syrup (Prednisolone Oral Solution, USP) 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.
⛔ Contraindications ▾
CONTRAINDICATIONS Systemic fungal infections.
⚠️ Warnings ▾
WARNINGS 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 Syrup (Prednisolone Oral Solution, USP), 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 Syrup (Prednisolone Oral Solution, USP) withdrawal or dosage reduction as needed. Do not administer Prednisolone Syrup (Prednisolone Oral Solution, USP) by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.
Tuberculosis If Prednisolone Syrup (Prednisolone Oral Solution, USP) 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 Syrup (Prednisolone Oral Solution, USP) 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 Syrup (Prednisolone Oral Solution, USP). 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 Syrup (Prednisolone Oral Solution, USP)-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 Syrup (Prednisolone Oral Solution, USP)-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 Syrup (Prednisolone Oral Solution, USP).
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 Syrup (Prednisolone Oral Solution, USP). 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 Syrup (Prednisolone Oral Solution, USP), may exacerbate systemic fungal infections; therefore, avoid Prednisolone Syrup (Prednisolone Oral Solution, USP) use in the presence of such infections unless Prednisolone Syrup (Prednisolone Oral Solution, USP) is needed to control drug reactions. For patients on chronic Prednisolone Syrup (Prednisolone Oral Solution, USP) therapy who develop systemic fungal infections, Prednisolone Syrup (Prednisolone Oral Solution, USP) withdrawal or dosage reduction is recommended.
Amebiasis Corticosteroids, including Prednisolone Syrup (Prednisolone Oral Solution, USP), may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating Prednisolone Syrup (Prednisolone Oral Solution, USP) in pat…
🤒 Adverse Reactions ▾
ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Neurological Convulsions Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs such as prednisolone are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids such as prednisolone cause profound and varied metabolic effects.
In addition, they modify the body's immune responses to diverse stimuli.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Prednisolone Syrup (Prednisolone Oral Solution, USP) is a cherry flavored red liquid containing 15 mg of prednisolone in each 5 mL (teaspoonful) and is supplied as follows: NDC 0527-5406-68 240 mL NDC 0527-5406-70 480 mL Pharmacist: Dispense with a suitable calibrated measuring device to assure proper measuring of dose. DOSE/VOLUME CHART 15 mg prednisolone = 1 teaspoon 10 mg prednisolone = 2/3 teaspoon 7.5 mg prednisolone = 1/2 teaspoon 5 mg prednisolone = 1/3 teaspoon Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Refrigerate.
Pharmacist: Dispense with a suitable calibrated measuring device to assure proper measuring of dose. DOSE/VOLUME CHART 15 mg prednisolone = 1 teaspoon 10 mg prednisolone = 2/3 teaspoon 7.5 mg prednisolone = 1/2 teaspoon 5 mg prednisolone = 1/3 teaspoon
📦 Storage and Handling ▾
Dispense in tight, light-resistant and child-resistant containers as defined in the USP/NF. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do Not Refrigerate.
📋 Description ▾
DESCRIPTION Prednisolone Syrup (Prednisolone Oral Solution, USP) contains prednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisolone is a white to practically white, odorless, crystalline powder.
It is very slightly soluble in water; soluble in methanol and in dioxane; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for prednisolone is Pregna-1,4-diene-3,20-dione,11,17,21-trihydroxy-,(11β). Prednisolone Syrup (Prednisolone Oral Solution, USP) contains 15 mg of prednisolone in each 5 mL.
Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5% v/v, cherry flavor, citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, glycerin, propylene glycol, purified water, sodium saccharin, and sucrose. Prednisolone Syrup (Prednisolone Oral Solution, USP) may contain sodium citrate for pH adjustment.
This is an image of the structural formula of Prednisolone.
💬 Information for Patients ▾
Information for Patients: Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.