Home › NDC Lookup › Ingredients › Prednisolone › 50090-7115-01
Prednisolone 15 mg/5mL Solution — NDC 50090-7115-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Prednisolone 15 mg/5mL Solution — NDC 50090-7115-1 (Billing 50090-7115-01)

by A-S Medication Solutions · 4 BOTTLE, DISPENSING in 1 BOTTLE / 60 mL in 1 BOTTLE, DISPENSING

This is a package of Prednisolone 15 mg/5mL Solution from A-S Medication Solutions, marketed since Sep 2023 and currently FDA-listed.

NDC 50090-7115-01
🏷️ FDA NDC (as labeled) 50090-7115-1 billing pads the package segment with a zero
This package
Contains60 mL in 1 bottle, dispensing Pack sizes2 compare ↓
Also priced by: Part D plans $0.5590/unit — full pricing hub ↓
Product page 50090-7115-00 Also comes in: 2 bottles 50090-7115-0
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 →

This page is curated, coded, and maintained by

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) 50090-7115-1
Product NDC 50090-7115
11-digit billing NDC 50090711501
NCPDP billing unit ML — per mL (volume)
RxCUI 283077
UNII 9PHQ9Y1OLM
Application # ANDA040571
SPL Set ID 35f0b197-c3ae-445a-8da7-9ffcd4472e05
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 2023-09-12
Route ORAL
Dosage form SOLUTION
Substance PREDNISOLONE
TE code (Orange Book) AA · RLD · RS

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

GCN Seq No 006719
GCN 26800
HICL code 002874
Ingredient (HICL) Prednisolone
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 15 MG/5 ML SOLN
FDB brand name Prednisolone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006719
  • GCN: 26800
  • HICL (First Databank): 002874
  • AHFS class code: 52:08.08.00
  • RxCUI (RxNorm): 283077
Why two NDCs? The FDA registers this code as 50090-7115-1 — a 5-4-1 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 package segment → 50090-7115-01. 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 15 MG/5 ML SOLN Ingredient Prednisolone
📖 What it is MedlinePlus · NLM

Prednisolone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisolone is also used to treat certain conditions that affect the blood, skin, eyes, central nervous system, kidneys, lungs, stomach, and intestines. It is also used to treat allergic reactions; and certain types of arthritis; multiple sclerosis (a disease in which the nerves do not function properly); and to help prevent transplant rejection (attack of the transplanted organ by...

Read the full MedlinePlus article ↗
📗 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 →
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 Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.5590 $134.16 / 240 ml
Medicare Part B allowsASP · J7510 $0.777 / J7510 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)50090-7115-1
11-digit billing NDC50090-7115-01
Format5-4-1 as registered → padded to 5-4-2 for billing (zero added to the package segment)
HCPCS J-codeJ7510
DescriptorPrednisolone oral, per 5 mg
Billing units / pkg144 units
How the units are derivedThis package is 240; the HCPCS unit is 5 MG, so one package = 144 billing units.
Medicare Part B spend (2026 (Q1))$2,432 · 116 claims · $20.96 per claim (all NDCs under J7510)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-7115-00 50090-7115-0 Main listing 2 BOTTLE, DISPENSING in 1 BOTTLE / 120 mL in 1 BOTTLE, DISPENSING 2024-03-12 — Active
50090-7115-01 You're viewing this 4 BOTTLE, DISPENSING in 1 BOTTLE / 60 mL in 1 BOTTLE, DISPENSING 2024-03-12 — Active

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 4 bottle, dispensing in 1 bottle / 60 ml in 1 bottle, dispensing.
What NDC number is used to bill for this package of Prednisolone 15 mg/5mL Solution?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prednisolone Sodium Phosphate 15 mg/5mL 00121-0759-08 PAI 237 ml $0.103 AA Availability likely —
Prednisolone Sodium Phosphate 15 mg/5mL 42799-0815-01 Edenbridge 237 ml $0.103 AA Availability likely —
Prednisolone Sodium Phosphate 15 mg/5mL 69238-2122-09 Amneal 237 ml $0.103 AA Availability likely —
Prednisolone 15 mg/5mL 00121-0885-08 PAI 240 ml $0.568 AA Availability likely —
PrednisoLONE 15 mg/5mL 00527-5406-68 Lannett 240 ml $0.568 AA Availability likely —
Prednisolone 15 mg/5mL 23155-0927-51 Heritage 240 ml $0.568 AA Availability likely —
Prednisolone 15 mg/5mL 62135-0250-37 Chartwell 240 ml $0.568 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/5mLthis 50090-7115-01 A-S 4 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 —
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

🏛️
2023
On the market since
Sep 2023
📍
2026
Currently FDA-listed
3 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

Color pink
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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII XF417D3PSL
    Anhydrous citric acid is a sour, crystalline powder derived from citric acid with water removed. In medicines, it acts as a buffer to control pH, adds tartness to improve taste, and helps tablets disintegrate.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

11 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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

LabelerA-S Medication Solutions
Application holderPHARMACEUTICAL ASSOCIATES INC
FDA applicationANDA040571 (ANDA)
Labeler code50090
First marketedSep 2023
Product typeHuman Prescription Drug
Portfolio2,811 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE 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 Disorders 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 Oral Solution USP is indicated for systemic dermatomyositis (polymyositis).

⏱️ Dosage and Administration ~2 min read ▾

DOSAGE AND ADMINISTRATION Dosage of prednisolone oral solution 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 oral solution 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 oral solution 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 oral solution 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 4 words ▾

CONTRAINDICATIONS Systemic fungal infections.

⚠️ Warnings ~2 min read ▾

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 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 Oral Solution USP withdrawal or dosage reduction as needed. Do not administer Prednisolone Oral Solution USP by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection.

Tuberculosis 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 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 Oral Solution USP. In corticosteroids-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 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 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 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 Oral Solution USP. For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including Prednisolone Oral Solution USP, may exacerbate systemic fungal infections; therefore, avoid Prednisolone Oral Solution USP use in the presence of such infections unless Prednisolone Oral Solution USP is needed to control drug reactions.

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

Strongyloides Infestatio n Corticosteroids, including Prednisolone Oral Solution USP, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and disseminat… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 174 words ▾

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 pediatric patients 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 PAI Pharma at 1-800-845-8210 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🧬 Clinical Pharmacology 63 words ▾

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 30 words ▾

HOW SUPPLIED Product: 50090-7115 NDC: 50090-7115-0 120 mL in a BOTTLE, DISPENSING / 2 in a BOTTLE NDC: 50090-7115-1 60 mL in a BOTTLE, DISPENSING / 4 in a BOTTLE

📋 Description 128 words ▾

DESCRIPTION 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)-. C 21 H 28 O 5 M.W.

360.45 Prednisolone Oral Solution USP, 15 mg/5 mL contains 15 mg of prednisolone in each 5 mL. Benzoic acid, 0.1% is added as a preservative. It also contains alcohol 5%, citric acid (anhydrous), edetate disodium, glycerin, propylene glycol, purified water, saccharin sodium, sucrose, FD&C blue #1 and FD&C red #40.

Prednisolone Structure

💬 Information for Patients 38 words ▾

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.

⚠️ Precautions ~1 min read ▾

PRECAUTIONS General: Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently.

There is an enhanced effect of corticosteroids on patients with hypothyroidism and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also, existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis if there is a probability of impending perforation, abscess or other pyogenic infections; diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis; and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. 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.

📄 Package Label / Principal Display Panel 3 words ▾

Prednisolone Label Image

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

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

Medicare Part D (outpatient prescription) spending for Prednisolone — 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. 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
$614.9K
Claims incl. refills
5.4K
Beneficiaries
4.7K
Spend / beneficiary
$132.08
Spend / claim
$114.07
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.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk ✓ Available
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by A-S Medication Solutions. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 2 bottles (50090-7115-00). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J7510 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 50090-7113-00 · A-S 50090-7116-00 · A-S →
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.