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PREDNISONE 2.5 mg Tablet, 21-count — NDC 87063-0042-21 package photo

PREDNISONE 2.5 mg Tablet, 21-count

by ASCLEMED USA INC. · 21 TABLET in 1 BOTTLE (87063-042-21)
NDC 87063-0042-21
🏷️ FDA NDC (as labeled) 87063-042-21 billing pads the product segment with a zero
This package
Contains21-count Pack sizes8 compare ↓
Also priced by: Part D plans $0.2837/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 87063-042-21
Product NDC 87063-042
11-digit billing NDC 87063004221
UNII VB0R961HZT
Application # ANDA215672
SPL Set ID bf6ebe58-e7bb-49d3-842e-3372f8ba6172
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 2022-03-28
Route ORAL
Dosage form TABLET
Substance PREDNISONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 87063-042-21 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 87063-0042-21. 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.

🏭 Manufacturer & labeler

LabelerASCLEMED USA INC.
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA215672 (ANDA)
Labeler code87063
First marketedMar 2022
Product typeHuman Prescription Drug
Portfolio122 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Prednisone calms down your immune system and reduces inflammation in your body. It's used for a huge range of conditions — everything from asthma and severe allergies to Crohn's di...
  • Why did my doctor put me on prednisone — what does it actually do?
  • Yes, morning really does matter — your body naturally produces its own cortisol hormone between 2 a.m. and 8 a.m., and taking prednisone at that time works with your body's rhythm...
  • Do I really have to take it in the morning? And does it matter if I take it with food?
📖 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.

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.

💊 What it looks like

Color orange / yellow / white
ShapeRound
ImprintPI;50
Size11 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 CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

6 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 DailyMedingredient 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.

💲 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 eachPer 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 $0.2837 $5.96 / 21 tablets
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PredniSONE 2.5 mg 00054-4742-25 Hikma 100 tablets $0.068 AB Availability likely
Prednisone 2.5 mg 00603-5336-21 Par 100 tablets $0.068 AB Availability likely
Prednisone 2.5 mg 59651-0485-01 Aurobindo 100 tablets $0.068 AB Availability likely
Prednisone 2.5 mg 70954-0057-10 ANI 100 tablets $0.068 AB Availability likely
PredniSONE 2.5 mg 00054-8740-25 Hikma 100 tablets $0.082 AB FDA listed
Prednisone 2.5 mg 10135-0775-01 Marlex 100 tablets AB FDA listed
prednisone 2.5 mg 50090-7235-00 A-S 30 tablets FDA listed
Prednisone 2.5 mg 50090-7825-00 A-S 30 tablets AB FDA listed
Prednisone 2.5 mg 51655-0197-52 Northwind 30 tablets AB FDA listed
PredniSONE 2.5 mg 51655-0763-52 Northwind 30 tablets FDA listed
Prednisone 2.5 mg 63629-2260-01 Bryant 100 tablets AB FDA listed
prednisone 2.5 mg 64380-0835-01 Strides 100 tablets AB FDA listed
Prednisone 2.5 mg 67046-1448-03 Coupler 30 tablets AB FDA listed
prednisone 2.5 mg 68788-8184-03 Preferred 30 tablets FDA listed
Prednisone 2.5 mg 68788-8858-01 Preferred 15 tablets AB FDA listed
prednisone 2.5 mg 71335-2088-01 Bryant 30 tablets FDA listed
Prednisone 2.5 mg 71335-2356-01 Bryant 30 tablets AB FDA listed
Prednisone 2.5 mgthis 87063-0042-21 ASCLEMED 21 tablets AB 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

🏛️
2022
On the market since
Mar 2022
📍
2026
Currently FDA-listed
4 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.

📊 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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for PREDNISONE — the ingredient across all brands.

Top reported reactions

Fatigue40,822
Pain37,875
Dyspnoea34,944
Arthralgia33,224
Condition Aggravated28,616
Nausea28,568
Diarrhoea28,439

Age at onset

Neonate961
Infant454
Child2,120
Adolescent2,238
Adult56,838
Elderly32,373

Reporter sex

499,938 reports
Male · 40%
Female · 60%
Unknown · 0%

Serious outcomes

Hospitalization172,740
Death52,152
Life-threatening26,074
Disabling16,512
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 42,464 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
87063-0042-01 100 TABLET in 1 BOTTLE (87063-042-01) 2025-12-03 Active
87063-0042-18 18 TABLET in 1 BOTTLE (87063-042-18) 2025-12-03 Active
87063-0042-20 20 TABLET in 1 BOTTLE (87063-042-20) 2025-12-03 Active
87063-0042-21 You're viewing this 21 TABLET in 1 BOTTLE (87063-042-21) 2025-12-03 Active
87063-0042-30 30 TABLET in 1 BOTTLE (87063-042-30) 2025-12-03 Active
87063-0042-60 60 TABLET in 1 BOTTLE (87063-042-60) 2025-12-03 Active
87063-0042-78 10 BLISTER PACK in 1 CARTON (87063-042-78) / 10 TABLET in 1 BLISTER PACK 2025-12-03 Active
87063-0042-90 90 TABLET in 1 BOTTLE (87063-042-90) 2025-12-03 Active

Pack size FAQ

What quantity is in NDC 87063-0042-21?
NDC 87063-0042-21 is a 21-count package — 21 tablet in 1 bottle.
What is the difference between NDC 87063-0042-21 and NDC 87063-0042-18?
Both are PREDNISONE 2.5 mg Tablet — the drug itself is identical. NDC 87063-0042-21 is the 21-count package, while NDC 87063-0042-18 is the 18 tablets package.
What NDC number is used to bill for this package of PREDNISONE 2.5 mg Tablet?
Bill NDC 87063-0042-21 — the 11-digit billing format is 87063004221. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
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 FDA registers it as 87063-042-21, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 87063-0042-21, written without dashes as 87063004221. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 87063-0042-21, the first segment (87063) is the labeler code FDA assigned to ASCLEMED USA INC.; the middle segment (0042) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (21) identifies this exact package size and type. Together they name one specific package of one specific product.
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 ASCLEMED USA INC.. 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 7 other package presentations of this same product, including 18 tablets (87063-0042-18), 20 tablets (87063-0042-20), 30 tablets (87063-0042-30). 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?
ASCLEMED USA INC. 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.
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.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE Prednisone tablets are indicated in the following conditions: 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 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.

Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 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 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 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 Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 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.

Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis Nervous System Acute exacerbations of multiple sclerosis 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 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.) Alternate Day Therapy Alternate day therapy 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…

Contraindications 14 words

CONTRAINDICATIONS Prednisone tablets are contraindicated in systemic fungal infections and known hypersensitivity to components.

⚠️ Warnings ~2 min read

WARNINGS In patients on corticosteroid therapy subject to any 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. Prolonged use of corticosteroids m…

🤒 Adverse Reactions 170 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 Metabolic Negative nitrogen balance due to protein catabolism Neurological Increased intracranial pressure with papilledema (pseudo-tumor 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 Addit i onal React i ons Urticaria and other allergic, anaphylactic or hypersensitivity reactions

🧬 Clinical Pharmacology 57 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 are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

📦 How Supplied / Storage and Handling ~2 min read

HOW SUPPLIED Prednisone Tablets USP, 2.5 mg are yellow colored, round, biconvex tablets, scored on one side and “PE”, “11” on other side. They are supplied as follows: Bottles of 18 NDC 87063-042-18 (repackaged from NDC 59651-485-XX) Bottles of 20 NDC 87063-042-20 (repackaged from NDC 59651-485-XX) Bottles of 21 NDC 87063-042-21 (repackaged from NDC 59651-485-XX) Bottles of 30 NDC 87063-042-30 (repackaged from NDC 59651-485-XX) Bottles of 60 NDC 87063-042-60 (repackaged from NDC 59651-485-XX) Bottles of 90 NDC 87063-042-90 (repackaged from NDC 59651-485-XX) Bottles of 100 NDC 87063-042-01 (relabeled from NDC 59651-485-01) 10x10 Unit-dose Tablets NDC 87063-042-78 (relabeled from NDC 59651-485-78) Prednisone Tablets USP, 5 mg are orange colored, round, biconvex tablets, scored on one side and “PI”, “5” on other side.

They are supplied as follows: Bottles of 18 NDC 87063-043-18 (repackaged from NDC 59651-486-XX) Bottles of 20 NDC 87063-043-20 (repackaged from NDC 59651-486-XX) Bottles of 21 NDC 87063-043-21 (repackaged from NDC 59651-486-XX) Bottles of 30 NDC 87063-043-30 (repackaged from NDC 59651-486-XX) Bottles of 60 NDC 87063-043-60 (repackaged from NDC 59651-486-XX) Bottles of 90 NDC 87063-043-90 (repackaged from NDC 59651-486-XX) Bottles of 100 NDC 87063-043-01 (relabeled from NDC 59651-486-01) 10x10 Unit-dose Tablets NDC 87063-043-78 (relabeled from NDC 59651-486-78) Prednisone Tablets USP, 10 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “10” on other side.

They are supplied as follows: Bottles of 18 NDC 87063-044-18 (repackaged from NDC 59651-487-XX) Bottles of 20 NDC 87063-044-20 (repackaged from NDC 59651-487-XX) Bottles of 21 NDC 87063-044-21 (repackaged from NDC 59651-487-XX) Bottles of 30 NDC 87063-044-30 (repackaged from NDC 59651-487-XX) Bottles of 60 NDC 87063-044-60 (repackaged from NDC 59651-487-XX) Bottles of 90 NDC 87063-044-90 (repackaged from NDC 59651-487-XX) Bottles of 100 NDC 87063-044-01 (relabeled from NDC 59651-487-01) 10x10 Unit-dose Tablets NDC 87063-044-78 (relabeled from NDC 59651-487-78) Prednisone Tablets USP, 20 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “20” on other side.

They are supplied as follows: Bottles of 18 NDC 87063-045-18 (repackaged from NDC 59651-488-XX) Bottles of 20 NDC 87063-045-20 (repackaged from NDC 59651-488-XX) Bottles of 21 NDC 87063-045-21 (repackaged from NDC 59651-488-XX) Bottles of 30 NDC 87063-045-30 (repackaged from NDC 59651-488-XX) Bottles of 60 NDC 87063-045-60 (repackaged from NDC 59651-488-XX) Bottles of 90 NDC 87063-045-90 (repackaged from NDC 59651-488-XX) Bottles of 100 NDC 87063-045-01 (relabeled from NDC 59651-488-01) 10x10 Unit-dose Tablets NDC 87063-045-78 (relabeled from NDC 59651-488-78) Prednisone Tablets USP, 50 mg are white to off-white, round, biconvex tablets, scored on one side and “PI”, “50” on other side.

They are supplied as follows: Bottles of 18 NDC 87063-048-18 (repackaged from NDC 59651-489-XX) Bottles of 20 NDC 87063-048-20 (repackaged from NDC 59651-489-XX) Bottles of 21 NDC 87063-048-21 (repackaged from NDC 59651-489-XX) Bottles of 30 NDC 87063-048-30 (repackaged from NDC 59651-489-XX) Bottles of 60 NDC 87063-048-60 (repackaged from NDC 59651-489-XX) Bottles of 90 NDC 87063-048-90 (repackaged from NDC 59651-489-XX) Bottles of 100 NDC 87063-048-01 (relabeled from NDC 59651-489-01) 10x10 Unit-dose Tablets NDC 87063-048-78 (relabeled from NDC 59651-489-78) Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature].

Dispense in a tight, child-resistant container as defined in the USP/NF. PROTECT FROM MOISTURE. Relabeled and Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📋 Description 149 words

DESCRIPTION Prednisone tablets, USP are available for oral administration containing either 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone USP. Each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. In addition, 2.5 mg contains D&C yellow No.10 aluminum lake and 5 mg contains FD&C yellow # 6 aluminum lake.

Prednisone tablets, USP contain prednisone USP which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. 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 Prednisone USP is a white to partially white, odorless crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol.

FDA approved dissolution test specifications differ from USP. Chemical Structure

💬 Information for Patients 29 words

Information for the Patient Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

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