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PredniSONE 5 mg/5mL Solution, 120 mL — NDC 00054-3722-50 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

PredniSONE 5 mg/5mL Solution, 120 mL — NDC 0054-3722-50 (Billing 00054-3722-50)

by Hikma Pharmaceuticals USA Inc. · 120 mL in 1 BOTTLE

This is a package of 120 mL of PredniSONE 5 mg/5mL Solution from Hikma Pharmaceuticals USA Inc., marketed since Nov 1984 and currently FDA-listed; retail pharmacies pay about $0.4331 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00054-3722-50
🏷️ FDA NDC (as labeled) 0054-3722-50 billing pads the labeler segment with a zero
This package
Contains120 mL Cost per mL$0.4331 NADAC Per package$51.97 / 120 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.5277/unit · Part D plans $0.5832/unit — full pricing hub ↓
Main listing for product 0054-3722 · Also comes in: 500 ml 0054-3722-63
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

NDC database record

One package, one record: these facts belong to NDC 0054-3722-50 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0054 labeler · 3722 product · 50 package
Package marketed since
Dec 13, 1996
Sample package
No — commercial package
Listing certified through
Dec 31, 2026
Billing quantity
120 mL per package
Barcode (UPC)
0300543722507
Medicaid fills, this package
20,732 prescriptions in the last four reported quarters
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0054-3722-50
Product NDC 0054-3722
11-digit billing NDC 00054372250
NCPDP billing unit ML — per mL (volume)
RxCUI 198144, 198145, 198146, 198148, 205301, 312615, 312617, 315187
UNII VB0R961HZT
UPC 0300543722507
Application # ANDA088703
SPL Set ID 3115aef0-fd50-4ec8-a064-3effb695f3f2
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 1984-11-08
Route ORAL
Dosage form SOLUTION
Substance PREDNISONE

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

GPI-14 22100045002005
GPI class predniSONE
GCN Seq No 006746
GCN 27160
HICL code 002879
Ingredient (HICL) Prednisone
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 68:04.00.00
AHFS class Adrenals
FDB label name PREDNISONE 5 MG/5 ML SOLUTION
FDB brand name Prednisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006746
  • GCN: 27160
  • GPI-14 (Medi-Span): 22100045002005
  • HICL (First Databank): 002879
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 198144
Why two NDCs? The FDA registers this code as 0054-3722-50 — a 4-4-2 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 labeler segment → 00054-3722-50. 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 acting locally, Glucocorticoids
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 PREDNISONE 5 MG/5 ML SOLUTION Ingredient Prednisone
📗 Our plain-language guide HelloPharmacist
  • It calms inflammation and lowers immune activity. It is used for allergies, arthritis, lupus, skin, gut, lung, eye and blood conditions, and more. Your prescriber chose it for your...
  • Take it with food or milk to protect your stomach. A once-daily dose is usually best in the morning. If you have delayed-release tablets, take them with food and swallow them whole...
  • No, not after long-term use. Your body may need time to restart its own steroid production. Your doctor will lower the dose gradually.
  • Bigger appetite, weight gain, trouble sleeping, mood swings and stomach upset are common. Call your doctor for signs of infection, black stools, severe stomach pain, vision changes...
📖 Read our full Prednisone guide →
8
Nutrient depletion considerations

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

🧪 Full Prednisone 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 $0.433 $51.97 / 120 ml
Medicaid paysCMS SDUD · 12 mo $0.5277 $63.32 / 120 ml
Medicare drug plans payPart D · Q2 2026 $0.5832 $69.98 / 120 ml
Medicare Part B allowsASP · J7512 $0.004 / J7512 unit —
NADAC price history (per mL) — tap or hover for the price & month
Sep 2021 Sep 2022 Feb 2026 Sep 2026 $0.615 $0.415
▼ Down 29% over the last 20 months.
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)0054-3722-50
11-digit billing NDC00054-3722-50
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7512
DescriptorPREDNISONE, IMMEDIATE RELEASE OR DELAYED RELEASE, ORAL, 1 MG
Billing units / pkg1 units
How the units are derivedThis package is 120 ML; the HCPCS unit is 1 MG, so one package = 1 billing unit.
Medicare Part B spend (2026 (Q1))$63,912 · 65,179 claims · $0.98 per claim (all NDCs under J7512)
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
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 Per unit Per pack Marketing startMarketing endStatus
00054-3722-50 You're viewing this Main listing 120 mL in 1 BOTTLE $0.4331 / mL $51.97 1996-12-13 — Active
00054-3722-63 0054-3722-63 500 mL in 1 BOTTLE $0.6054 / mL $302.72 1984-11-08 — Active

You're viewing the smallest of 2 pack sizes for this product.

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.4331 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 88% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package contains 120 mL — 120 ml in 1 bottle.
How does this package differ from NDC 00054-3722-63?
Both are PredniSONE 5 mg/5mL Solution — the drug itself is identical. This page's package is the 120 mL one, while NDC 00054-3722-63 is the 500 ml package. Per-mL NADAC also differs: $0.4331 here vs $0.6054 for the 500 ml pack.
What NDC number is used to bill for this package of PredniSONE 5 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.

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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PredniSONE 5 mg/5mLthis 00054-3722-50 Hikma 120 ml $0.433 — Availability likely —
PredniSONE 5 mg/5mL 17856-3722-01 Atlantic 5 ml — — 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

🏛️
1984
On the market since
Nov 1984
📍
2026
Currently FDA-listed
42 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 White
ShapeRound
Imprint54;612
Size6 mm
ScoringScored — splits in 2
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 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 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 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 6YSS42VSEV
    Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
  • UNII QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 3A9RD92BS4
    Maltol is a naturally occurring organic compound found in foods like bread crust and coffee. In medicines, it acts as a flavoring agent to mask bitter tastes and improve palatability.
  • UNII AV092KU4JH
    A natural oil extracted from peppermint plants. It's used as a flavoring agent to mask bitter tastes and add a refreshing mint flavor to medicines, making them easier to take.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.
  • 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?
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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA088703 (ANDA)
Labeler code00054
First marketedNov 1984
Product typeHuman Prescription Drug
Portfolio726 products on file

More NDCs from Hikma Pharmaceuticals USA Inc. labeler code 00054

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 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS Prednisone tablets and solutions are 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 Hypercalcemia associated with cancer Nonsuppurative thyroiditis 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 Systemic dermatomyositis (polymyositis) 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 antituberculous 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. Nervous System Acute exacerbations of multiple sclerosis 13.

Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The initial dosage of prednisone may vary from 5 mg to 60 mg of prednisone 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, prednisone 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 prednisone 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. Multiple Sclerosis 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 for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) ADT ® (Alternate Day Therapy) ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.

The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the Cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary- adrenal (HPA) activity on the off-steroid day.

A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion. Normally the HPA system is characterized by diurnal (circadian) rhythm.

Serum levels of ACTH rise from a low point about 10 pm to a peak level about 6 am. Increasing levels of ACTH stimulate adrenocortical activity resulting in a rise in plasma cortisol with maximal levels occurring between 2 am and 8 am. This rise in cortisol dampens ACTH production and in turn adrenocortical activity.

There is a gradual fall in plasma corticoids during the day with lowest levels occurring about midnight. The diurnal rhythm of the HPA axis is lost in Cushing’s disease, a syndrome of adrenocortical hyperfunction characterized by obesity with centripetal fat distribution, thinning of the skin with easy bruisability, muscle wasting with weakness, hypertension, latent diabetes, osteoporosis, electrolyte imbalance, etc. The same clinical findings of hyperadrenocorticism may be noted during l… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 9 words ▾

CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.

⚠️ 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 prednisone, 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 prednisone withdrawal or dosage reduction as needed. Tuberculosis If prednisone 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 prednisone 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 prednisone.

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 prednisone-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 prednisone-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 prednisone.

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 prednisone. 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 prednisone, may exacerbate systemic fungal infections; therefore, avoid prednisone use in the presence of such infections unless prednisone is needed to control drug reactions. For patients on chronic prednisone therapy who develop systemic fungal infections, prednisone withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including prednisone, may activate latent amebiasis.

Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating prednisone in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including prednisone, 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 dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Cerebral Malaria Avoid corticosteroids, including prednisone, in patients with cerebral malaria. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions. Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma.

Usage in pregnancy Si… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 173 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 Tendon rupture, particularly of the Achilles tendon 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 Metabolic Negative nitrogen balance due to protein catabolism Neurological Increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Suppression of growth in children 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 Additional Reactions Urticaria and other allergic, anaphylactic or hypersensitivity reactions

📦 How Supplied / Storage and Handling ~2 min read ▾

HOW SUPPLIED PredniSONE Tablets, USP 1 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side. NDC 0054-8739-25: 10x10 Unit-Dose NDC 0054-4741-25: Bottle of 100 Tablets NDC 0054-4741-31: Bottle of 1,000 Tablets 2.5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side. NDC 0054-8740-25: 10x10 Unit-Dose NDC 0054-4742-25: Bottle of 100 Tablets 5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side.

NDC 0054-8724-25: 10x10 Unit-Dose NDC 0054-4728-25: Bottle of 100 Tablets NDC 0054-4728-31: Bottle of 1,000 Tablets 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 0054-0017-20: 10x10 Unit-Dose NDC 0054-0017-25: Bottle of 100 Tablets NDC 0054-0017-29: Bottle of 500 Tablets 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. NDC 0054-0018-20: 10x10 Unit-Dose NDC 0054-0018-25: Bottle of 100 Tablets NDC 0054-0018-29: Bottle of 500 Tablets 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side.

NDC 0054-0019-20: 10x10 Unit-Dose NDC 0054-0019-25: Bottle of 100 Tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless, slightly viscous solution.

NDC 0054-3722-50: Bottle of 120 mL NDC 0054-3722-63: Bottle of 500 mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution. NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to 1 mL [5 mg] on the syringe) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense only in the bottle and only with the calibrated oral syringe provided.

Discard opened bottle after 90 days. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000278/04 -k02 Revised February 2024

📋 Description 200 words ▾

DESCRIPTION Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder.

It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: C 21 H 26 O 5 M.W.

358.44 Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or 50 mg of prednisone. PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and PredniSONE Intensol TM Oral Solution (Concentrate) contains 5 mg prednisone per mL. Inactive Ingredients: PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).

PredniSONE Oral Solution, USP contains alcohol 5% and the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. PredniSONE Intensol™ Oral Solution (Concentrate) contains alcohol 30% and the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Chemical Structure

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Precautions 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 infection; 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. Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that corticosteroids affect the ultimate outcome or natural history of the disease.

The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (see DOSAGE AND ADMINISTRATION ). Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin.

Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur.

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 8739 -25 10x10 Unit-Dose Tablets PredniSONE Tablets, USP 1 mg 1 mg Unit-Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 4741 -25 100 Tablets PredniSONE Tablets, USP 1 mg 1 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 8740 -25 10x10 Unit-Dose Tablets PredniSONE Tablets, USP 2.5 mg 2.5 mg Unit Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 4742 -25 100 Tablets PredniSONE Tablets , USP 2.5 mg 2.5 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 8724 -25 10x10 Unit-Dose Tablets PredniSONE Tablets, USP 5 mg 5 mg Unit Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 4728 -25 100 Tablets PredniSONE Tablets, USP 5 mg 5 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0017 -20 10x10 Unit-Dose Tablets PredniSONE Tablets , USP 10 mg 10 mg Unit Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0017 -25 100 Tablets PredniSONE Tablets , USP 10 mg 10 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0018 -20 10x10 Unit-Dose Tablets PredniSONE Tablets , USP 20 mg 20 mg Unit Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0018 -25 100 Tablets PredniSONE Tablets , USP 20 mg 20 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0019 -20 10x10 Unit-Dose Tablets PredniSONE Tablets , USP 50 mg 50 mg Unit Dose Carton - 10x10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 0019 -25 100 Tablets PredniSONE Tablets, USP 50 mg 50 mg Bottle Label - 100 count

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 3722 -50 120 mL PredniSONE Oral Solution, USP 5 mg per 5 mL Oral Solution Label - 120 mL

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0054- 3721 -44 30 mL PredniSONE Intensol™ Oral Solution (Concentrate) 5 mg per mL Intensol Oral Solution Label - 30 mL

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
20.7K
Units reimbursed last 4 qtrs
1.5M
Gross reimbursed last 4 qtrs
$789K
Avg / prescription
$38.06
Avg / unit
$0.5277
Latest quarter Q1 2026
4.9KRx
Medicaid pays / mL
$0.5277
gross reimbursed
vs
NADAC / mL
$0.4331
acquisition cost
=
Spread
+$0.0946
+22% 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 ⓘ
24% FFS 76% MCO
Fee-for-service · 5,011 Rx Managed care · 15,721 Rx
State Medicaid map
Alaska: no data reported AK Maine: 2,904 units · 208 per 100k residents ME Washington: 1,846 units · 23.6 per 100k residents WA Idaho: 1,997 units · 102 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 12,909 units · 225 per 100k residents MN Wisconsin: 29,033 units · 491 per 100k residents WI Michigan: 49,863 units · 497 per 100k residents MI New York: 31,418 units · 161 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 10,701 units · 253 per 100k residents OR Nevada: 16,077 units · 503 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10,123 units · 316 per 100k residents IA Illinois: 60,390 units · 481 per 100k residents IL Indiana: 37,590 units · 548 per 100k residents IN Ohio: 76,498 units · 649 per 100k residents OH Pennsylvania: 69,189 units · 534 per 100k residents PA New Jersey: 41,938 units · 451 per 100k residents NJ Massachusetts: 27,694 units · 396 per 100k residents MA California: 67,988 units · 174 per 100k residents CA Utah: 2,841 units · 83.1 per 100k residents UT Colorado: 14,599 units · 248 per 100k residents CO Nebraska: no data reported NE Missouri: 21,786 units · 352 per 100k residents MO Kentucky: 69,574 units · 1,537 per 100k residents KY West Virginia: 27,196 units · 1,536 per 100k residents WV Virginia: 34,218 units · 393 per 100k residents VA Maryland: 33,413 units · 541 per 100k residents MD Connecticut: 8,840 units · 244 per 100k residents CT Rhode Island: 14,620 units · 1,335 per 100k residents RI Arizona: 26,014 units · 350 per 100k residents AZ New Mexico: 32,244 units · 1,525 per 100k residents NM Kansas: 11,159 units · 380 per 100k residents KS Arkansas: 34,509 units · 1,125 per 100k residents AR Tennessee: 67,807 units · 952 per 100k residents TN North Carolina: 87,734 units · 810 per 100k residents NC South Carolina: 32,897 units · 612 per 100k residents SC Delaware: 3,984 units · 386 per 100k residents DE Oklahoma: 17,893 units · 441 per 100k residents OK Louisiana: 1,498 units · 32.8 per 100k residents LA Mississippi: 21,765 units · 740 per 100k residents MS Alabama: 36,263 units · 710 per 100k residents AL Georgia: 52,508 units · 476 per 100k residents GA D.C.: no data reported DC Hawaii: 2,844 units · 198 per 100k residents HI Texas: 166,746 units · 547 per 100k residents TX Florida: 124,143 units · 549 per 100k residents FL
Units reimbursed · per 100k residents
23.61,537
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 Kentucky 1,537 /100k
2 West Virginia 1,536 /100k
3 New Mexico 1,525 /100k
4 Rhode Island 1,335 /100k
5 Arkansas 1,125 /100k
6 Tennessee 952 /100k
7 North Carolina 810 /100k
8 Mississippi 740 /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.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
120 ml this page00054-3722-50 20,732 Rx · $788,980
500 ml00054-3722-63 2,820 Rx · $153,722
Drug total (last 4 qtrs): 23,552 Rx · 1,780,727 units · $942,702 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Prednisone — the program that covers self-administered drugs. 17 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 Prednisone. 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
$16.74M
Claims incl. refills
4.1M
Beneficiaries
3M
Spend / beneficiary
$5.57
Spend / claim
$4.04
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.
← 00054-3721-44 · Hikma 00054-3727-63 · Hikma →
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.