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PREDNISONE 5 mg Tablet, 21-count — NDC 61919-0365-21 package photo

PREDNISONE 5 mg Tablet, 21-count

by DIRECT RX · 21 TABLET in 1 DOSE PACK (61919-365-21)
NDC 61919-0365-21
🏷️ FDA NDC (as labeled) 61919-365-21 billing pads the product segment with a zero
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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 61919-365-21
Product NDC 61919-365
11-digit billing NDC 61919036521
NCPDP billing unit EA — each (per item)
RxCUI 312617, 763181
UNII VB0R961HZT
Application # ANDA040584
SPL Set ID 2a053775-6f6a-455e-b9a8-8b60e6062db3
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 2014-01-01
Route ORAL
Dosage form TABLET
Substance PREDNISONE
GPI-14 22100045000315
GPI class predniSONE
GCN Seq No 045267
GCN 38363
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 TAB DOSE PACK
FDB brand name Prednisone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 61919-365-21 — 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 → 61919-0365-21. 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

LabelerDIRECT RX
Application holderPH HEALTH LTD
FDA applicationANDA040584 (ANDA)
Labeler code61919
First marketedJan 2014
Product typeHuman Prescription Drug
Portfolio204 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

Label name PREDNISONE 5 MG TAB DOSE PACK Ingredient Prednisone
📖 What it is MedlinePlus · NLM

Prednisone 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). Prednisone is also used to treat other conditions in patients with normal corticosteroid levels. These conditions include certain types of arthritis; severe allergic reactions; multiple sclerosis (a disease in which the nerves do not function properly); lupus (a disease in which the body attacks many of its own organs); and certain conditions that affect the lungs, skin, eyes, kidneys...

Read the full MedlinePlus article ↗
📗 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.

🧪 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.

💊 What it looks like

Color white
ShapeRound
Imprint5094;V
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 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 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 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.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.

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 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.

💲 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 5 mg 60219-1706-01 Amneal 100 tablets $0.037 AB Availability likely —
PredniSONE Tablets, USP, 5 mg 63561-0120-01 Granulation 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 00378-0640-01 Mylan 100 tablets $0.037 — Availability likely —
prednisone 5 mg 60687-0903-01 American 100 tablets $0.037 AB Availability likely —
PredniSONE 5 mg 00054-9828-25 Hikma 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 59651-0486-01 Aurobindo 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 00591-5052-01 Actavis 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 60687-0122-01 American 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 62135-0471-18 Chartwell 180 tablets $0.037 — Availability likely —
Prednisone 5 mg 70954-0058-10 ANI 100 tablets $0.037 AB Availability likely —
PredniSONE 5 mg 00054-4728-25 Hikma 100 tablets $0.045 AB FDA listed —
PredniSONE 5 mg 00054-8724-25 Hikma 100 tablets $0.045 AB FDA listed —
Prednisone 5 mg 00603-5337-15 Par 21 tablets $0.360 AB Availability likely —
prednisone 5 mg 00615-8439-05 NCS 15 tablets — AB FDA listed —
Prednisone 5 mg 63187-0020-10 Proficient 10 tablets — AB FDA listed —
Prednisone 5 mg 63187-0066-05 Proficient 5 tablets — AB FDA listed —
Prednisone 5 mg 63187-0997-05 Proficient 5 tablets — AB FDA listed —
Prednisone 5 mg 67544-0399-60 Aphena 90 tablets — AB FDA listed —
Prednisone 5 mg 70882-0117-21 Cambridge 21 tablets — AB Discontinued —
Prednisone 5 mg 76420-0067-21 Asclemed 21 tablets — AB FDA listed —
prednisone 5 mg 50090-5814-00 A-S 21 tablets — — FDA listed —
PredniSONE 5 mg 50090-6619-00 A-S 21 tablets — AB FDA listed —
PredniSONE 5 mg 50090-6621-06 A-S 90 tablets — AB FDA listed —
PredniSONE 5 mg 50090-6623-00 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 80425-0482-01 Advanced 21 tablets — AB FDA listed —
prednisone 5 mg 42708-0186-21 QPharma 21 tablets — AB FDA listed —
Prednisone 5 mg 63629-1605-00 Bryant 42 tablets — AB FDA listed —
Prednisone 5 mg 80425-0479-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 87063-0043-01 ASCLEMED 100 tablets — AB FDA listed —
Prednisone 5 mg 55154-2146-00 Cardinal 10 tablets — AB FDA listed —
PredniSONE 5 mg 80425-0481-01 Advanced 21 tablets — AB FDA listed —
prednisone 5 mg 50090-7505-00 A-S 90 tablets — AB FDA listed —
Prednisone 5 mgthis 61919-0365-21 DIRECT 21 tablets — AB FDA listed —
PredniSONE 5 mg 68071-3581-01 NuCare 100 tablets — AB FDA listed —
PredniSONE 5 mg 80425-0480-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 70518-0305-00 REMEDYREPACK 21 tablets — AB FDA listed —
Prednisone 5 mg 80425-0069-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 66267-0172-06 NuCare 6 tablets — AB FDA listed —
Prednisone 5 mg 68071-3729-01 NuCare 21 tablets — AB FDA listed —
prednisone 5 mg 68788-8579-03 Preferred 30 tablets — — FDA listed —
PredniSONE 5 mg 70518-4271-00 REMEDYREPACK 100 tablets — AB FDA listed —
Prednisone 5 mg 71335-0508-00 Bryant 42 tablets — AB Discontinued —
PredniSONE Tablets, USP, 5 mg 72789-0474-01 PD-Rx 100 tablets — AB FDA listed —
Prednisone 5 mg 80425-0068-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 50090-3354-00 A-S 21 tablets — AB FDA listed —
Prednisone 5 mg 50090-3361-04 A-S 40 tablets — AB FDA listed —
Prednisone 5 mg 50090-7931-00 A-S 21 tablets — AB FDA listed —
Prednisone 5 mg 50090-7933-00 A-S 42 tablets — AB FDA listed —
prednisone 5 mg 51655-0068-21 Northwind 21 tablets — — FDA listed —
prednisone 5 mg 51655-0988-21 Northwind 21 tablets — AB FDA listed —
PredniSONE 5 mg 60760-0796-21 St. 21 tablets — AB FDA listed —
Prednisone 5 mg 63629-2261-01 Bryant 21 tablets — AB Discontinued —
prednisone 5 mg 64380-0783-01 Strides 100 tablets — AB FDA listed —
prednisone 5 mg 70518-3539-00 REMEDYREPACK 30 tablets — AB Discontinued —
prednisone 5 mg 71335-2134-00 Bryant 42 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 71335-2753-00 Bryant 42 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 71335-3043-01 Bryant 1000 tablets — AB FDA listed —
Prednisone 5 mg 71610-0834-30 Aphena 30 tablets — AB FDA listed —
Prednisone 5 mg 72162-2149-00 Bryant 1000 tablets — — FDA listed —
PredniSONE Tablets, USP, 5 mg 72162-2484-00 Bryant 1000 tablets — AB FDA listed —
Prednisone 5 mg 42708-0136-21 QPharma, 21 tablets — — FDA listed —
Prednisone 5 mg 50090-7124-00 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 50090-7684-00 A-S 21 tablets — AB FDA listed —
Prednisone 5 mg 51407-0921-10 Golden 1000 tablets — — FDA listed —
Prednisone 5 mg 70518-3537-00 REMEDYREPACK 21 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 71335-3042-01 Bryant 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 72789-0498-30 PD-Rx 30 tablets — AB FDA listed —
PredniSONE 5 mg 43063-0968-21 PD-Rx 21 tablets — AB FDA listed —
Prednisone 5 mg 50090-7935-00 A-S 90 tablets — AB FDA listed —
Prednisone 5 mg 63629-2264-01 Bryant 100 tablets — AB FDA listed —
Prednisone 5 mg 71335-1780-00 Bryant 42 tablets — AB FDA listed —
Prednisone 5 mg 80425-0106-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 10135-0776-01 Marlex 100 tablets — AB FDA listed —
Prednisone 5 mg 42708-0114-21 QPharma, 21 tablets — AB FDA listed —
Prednisone 5 mg 50090-0439-00 A-S 21 tablets — AB FDA listed —
prednisone 5 mg 50090-7688-00 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 55154-2582-00 Cardinal 10 tablets — AB FDA listed —
Prednisone 5 mg 68071-3742-01 NuCare 100 tablets — AB FDA listed —
Prednisone 5 mg 82804-0223-10 Proficient 10 tablets — AB FDA listed —
prednisone 5 mg 50090-7686-06 A-S 90 tablets — AB FDA listed —
PredniSONE 5 mg 51655-0355-26 Northwind 90 tablets — AB FDA listed —
Prednisone 5 mg 51655-0765-21 Northwind 21 tablets — — FDA listed —
prednisone 5 mg 67046-1642-03 Coupler 30 tablets — AB FDA listed —
Prednisone 5 mg 68788-9551-02 Preferred 21 tablets — AB FDA listed —
Prednisone 5 mg 72189-0593-21 Direct_Rx 21 tablets — — FDA listed —
Prednisone 5 mg 72789-0413-21 PD-Rx 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

🏛️
2014
On the market since
Jan 2014
📍
2026
Currently FDA-listed
12 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
61919-0365-21 You're viewing this 21 TABLET in 1 DOSE PACK (61919-365-21) 2014-01-01 Active

🧭 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 61919-365-21, 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: 61919-0365-21, written without dashes as 61919036521. 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 61919-0365-21, the first segment (61919) is the labeler code FDA assigned to DIRECT RX; the middle segment (0365) 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 DIRECT RX. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
DIRECT RX 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 ⏱️ Dosage and Administration ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS & USAGE 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 Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatlogic 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 Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy 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 when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE & ADMINISTRATION Gastric irritation may be reduced if taken before, during, or immediately after meals or with food or milk. The maximal activity of the adrenal cortex is between 2 am and 8 am, and it is minimal between 4 pm and midnight. Exogenous corticosteroids suppress adrenocorticoid activity the least when given at the time of maximal activity (am) for single dose administration.

Therefore, it is recommended that prednisone be administered in the morning prior to 9 am and when large doses are given, administration of antacids between meals to help prevent peptic ulcers. Multiple dose therapy should be evenly distributed in evenly spaced intervals throughout the day. Dietary salt restriction may be advisable in patients.

Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of PredniSONE Tablets 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, 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 increments 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 (ci…

⚠️ Warnings ~2 min read ▾

WARNINGS SECTION General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Cardio-Renal Average and large doses of hydrocortisone or cortisone can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium.

These effects are less likely to occur with the synthetic derivatives except when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients. Endocrine Corticosteroids can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for corticosteroid insufficiency after withdrawal of treatment. Adrenocortical insufficiency may result from too rapid withdrawal of corticosteroids and may be minimized by gradual reduction of dosage.

This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted. If the patient is receiving steroids already, dosage may have to be increased. Metabolic clearance of corticosteroids is decreased in hypothyroid patients and increased in hyperthyroid patients.

Changes in thyroid status of the patient may necessitate adjustment in dosage. Infection General Patients who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used.

Infection with any pathogen (viral, bacterial, fungal, protozoan or helminthic) in any location of the body may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents that affect cellular immunity, humoral immunity, or neutrophil function.1 These infections may be mild, but may be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases.2 Corticosteroids may also mask some signs of current infection.

Fungal Infections Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control life-threatening drug reactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see PRECAUTIONS: Drug Interactions: Amphotericin B Injection and Potassium-Depleting Agents). Special Pathogens Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or any patient with unexplained diarrhea. Similarly, corticosteroids 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.

Corticosteroids should not be used in cerebral malaria. Tuberculosis The use of prednisone in active tuberculosis should be restricted to those cases of fulminati…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS SECTION (listed alphabetically, under each subsection) The following adverse reactions have been reported with prednisone or other corticosteroids: Allergic Reactions anaphylactoid or hypersensitivity reactions, anaphylaxis, angioedema. Cardiovascular System bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, ECG changes caused by potassium deficiency, edema, fat embolism, hypertension or aggravation of hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS: Cardio-Renal), necrotizing angiitis, pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic acne, acneiform eruptions, allergic dermatitis, alopecia, angioedema, angioneurotic edema, atrophy and thinning of skin, dry scaly skin, ecchymoses and petechiae (bruising), erythema, facial edema, hirsutism, impaired wound healing, increased sweating, Karposi’s sarcoma (see PRECAUTIONS: General Precautions), lupus erythematosus-like lesions, perineal irritation, purpura, rash, striae, subcutaneous fat atrophy, suppression of reactions to skin tests, striae, telangiectasis, thin fragile skin, thinning scalp hair, urticaria.

Endocrine Adrenal insufficiency-greatest potential caused by high potency glucocorticoids with long duration of action (associated symptoms include; arthralgias, buffalo hump, dizziness, life-threatening hypotension, nausea, severe tiredness or weakness), amenorrhea, postmenopausal bleeding or other menstrual irregularities, decreased carbohydrate and glucose tolerance, development of cushingoid state, diabetes mellitus (new onset or manifestations of latent), glycosuria, hyperglycemia, hypertrichosis, hyperthyroidism (see WARNINGS: Endocrine), hypothyroidism, increased requirements for insulin or oral hypoglycemic agents in diabetics, lipids abnormal, moon face, negative nitrogen balance caused by protein catabolism, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery or illness) (see WARNINGS: Endocrine), suppression of growth in pediatric patients.

Fluid and Electrolyte Disturbances congestive heart failure in susceptible patients, fluid retention, hypokalemia, hypokalemic alkalosis, metabolic alkalosis, hypotension or shock-like reaction, potassium loss, sodium retention with resulting edema. Gastrointestinal abdominal distention, abdominal pain, anorexia which may result in weight loss, constipation, diarrhea, elevation in serum liver enzyme levels (usually reversible upon discontinuation), gastric irritation, hepatomegaly, increased appetite and weight gain, nausea, oropharyngeal candidiasis, pancreatitis, peptic ulcer with possible perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis, vomiting.

Hematologic anemia, neutropenia (including febrile neutropenia). Metabolic negative nitrogen balance due to protein catabolism. Musculoskeletal arthralgias, aseptic necrosis of femoral and humeral heads, increase risk of fracture, loss of muscle mass, muscle weakness, myalgias, osteopenia, osteoporosis (see PRECAUTIONS: Musculoskeletal), pathologic fracture of long bones, steroid myopathy, tendon rupture (particularly of the Achilles tendon), vertebral compression fractures.

Neurological/Psychiatric amnesia, anxiety, benign intracranial hypertension, convulsions, delirium, dementia (characterized by deficits in memory retention, attention, concentration, mental speed and efficiency, and occupational performance), depression, dizziness, EEG abnormalities, emotional instability and irritability, euphoria, hallucinations, headache, impaired cognition, incidence of severe psychiatric symptoms, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of trea…

🧬 Clinical Pharmacology 58 words ▾

CLINICAL PHARMACOLOGY SECTION 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 ~1 min read ▾

HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 1 mg (white, round, flat-faced, beveled edge, scored, debossed “5084” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5335-10 Bottles of 100 NDC 0603-5335-21 Bottles of 500 NDC 0603-5335-28 Bottles of 1000 NDC 0603-5335-32 2.5 mg (white, round, flat-faced, beveled edge, scored, debossed “5085” on one side and debossed “V” on the reverse side) Bottles of 10 NDC 0603-5336-10 Bottles of 100 NDC 0603-5336-21 Bottles of 500 NDC 0603-5336-28 Bottles of 1000 NDC 0603-5336-32 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5337-21 Bottles of 500 NDC 0603-5337-28 Bottles of 1000 NDC 0603-5337-32 Unit-of-Use (21 Tablets) NDC 0603-5337-15 Unit-of-Use (48 Tablets) NDC 0603-5337-31 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5338-21 Bottles of 500 NDC 0603-5338-28 Bottles of 1000 NDC 0603-5338-32 Unit-of-Use (21 Tablets) NDC 0603-5338-15 Unit-of-Use (48 Tablets) NDC 0603-5338-31 20 mg (peach, round, scored, debossed “5092” on one side and debossed “V” on the reverse side) Bottles of 100 NDC 0603-5339-21 Bottles of 500 NDC 0603-5339-28 Bottles of 1000 NDC 0603-5339-32 Unit-of-Use (21 Tablets) NDC 0603-5339-15 Unit-of-Use (48 Tablets) NDC 0603-5339-31 Dispense in a tight, light-resistant container as defined in the USP.

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. REFERENCES 1. Fekety R.

Infections associated with corticosteroids and immunosuppressive therapy. In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases.

Philadelphia: WBSaunders Company 1992:1050-1. 2. Stuck AE, Minder CE, Frey FJ.

Risk of infectious complications in patients taking glucocorticoids. Rev Infect Dis 1989:11(6):954-63. Manufactured for: QUALITEST PHARMACEUTICALS Huntsville, AL 35811 8182278 R9/11-R3

📋 Description 160 words ▾

DESCRIPTION SECTION PredniSONE Tablets contain prednisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone is a white to practically white, odorless, crystalline powder.

It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy-. The structural formula is represented below: PredniSONE Tablets are available in 5 strengths: 1 mg, 2.5 mg, 5 mg, 10 mg and 20 mg.

Inactive ingredients: 1 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 2.5 mg — lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, stearic acid; 5 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 10 mg—colloidal silicon dioxide, lactose monohydrate, magnesium stearate, pregelatinized starch, sodium starch glycolate; 20 mg—FD&C Yellow #6 Lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate. image description

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