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Prednisone 5 mg Tablet, 40-count — NDC 63187-0066-40 package photo

Prednisone 5 mg Tablet, 40-count

by Proficient Rx LP · 40 TABLET in 1 BOTTLE (63187-066-40)
NDC 63187-0066-40
🏷️ FDA NDC (as labeled) 63187-066-40 billing pads the product segment with a zero
This package
Contains40-count Pack sizes12 compare ↓
Also priced by: Part D plans $0.2837/unit — full pricing hub ↓
Also comes in: 5 tablets 63187-0066-05 6 tablets 63187-0066-06 8 tablets 63187-0066-08 9 tablets 63187-0066-09 12 tablets 63187-0066-12 15 tablets 63187-0066-15 20 tablets 63187-0066-20 21 tablets 63187-0066-21 24 tablets 63187-0066-24 30 tablets 63187-0066-30 42 tablets 63187-0066-42
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) 63187-066-40
Product NDC 63187-066
11-digit billing NDC 63187006640
RxCUI 198145, 312617
UNII VB0R961HZT
Application # ANDA040256
SPL Set ID 7d52bf53-76e3-4826-a12b-b16a8560bafc
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 2002-07-12
Route ORAL
Dosage form TABLET
Substance PREDNISONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-066-40 — 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 → 63187-0066-40. 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

LabelerProficient Rx LP
Application holderPH HEALTH LTD
FDA applicationANDA040256 (ANDA)
Labeler code63187
First marketedJul 2002
Product typeHuman Prescription Drug
Portfolio1,723 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

📖 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
Imprint5093;V
Size9 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 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 ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • 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.

5 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 $11.35 / 40 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 00054-9828-25 Hikma 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 00378-0640-01 Mylan 100 tablets $0.037 — Availability likely —
Prednisone 5 mg 00591-5052-01 Actavis 100 tablets $0.037 — Availability likely —
Prednisone 5 mg 59651-0486-01 Aurobindo 100 tablets $0.037 AB Availability likely —
prednisone 5 mg 60219-1706-01 Amneal 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 60687-0122-01 American 100 tablets $0.037 AB Availability likely —
prednisone 5 mg 60687-0903-01 American 100 tablets $0.037 AB Availability likely —
Prednisone 5 mg 62135-0471-18 Chartwell 180 tablets $0.037 — Availability likely —
PredniSONE Tablets, USP, 5 mg 63561-0120-01 Granulation 100 tablets $0.037 AB 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 10135-0776-01 Marlex 100 tablets — AB FDA listed —
Prednisone 5 mg 42708-0114-21 QPharma, 21 tablets — AB FDA listed —
Prednisone 5 mg 42708-0136-21 QPharma, 21 tablets — — FDA listed —
PredniSONE 5 mg 43063-0968-21 PD-Rx 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 50090-5814-00 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 50090-7124-00 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 50090-7505-00 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 50090-7684-00 A-S 21 tablets — AB FDA listed —
prednisone 5 mg 50090-7686-06 A-S 90 tablets — AB FDA listed —
prednisone 5 mg 50090-7688-00 A-S 90 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 50090-7935-00 A-S 90 tablets — AB FDA listed —
Prednisone 5 mg 51407-0921-10 Golden 1000 tablets — — FDA listed —
prednisone 5 mg 51655-0068-21 Northwind 21 tablets — — 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 51655-0988-21 Northwind 21 tablets — AB FDA listed —
Prednisone 5 mg 55154-2146-00 Cardinal 10 tablets — AB FDA listed —
prednisone 5 mg 55154-2582-00 Cardinal 10 tablets — AB FDA listed —
PredniSONE 5 mg 60760-0796-21 St. 21 tablets — AB FDA listed —
Prednisone 5 mg 63187-0020-10 Proficient 10 tablets — AB FDA listed —
Prednisone 5 mgthis 63187-0066-40 Proficient 40 tablets — AB FDA listed —
Prednisone 5 mg 63187-0997-05 Proficient 5 tablets — AB FDA listed —
Prednisone 5 mg 63629-1605-00 Bryant 42 tablets — AB FDA listed —
Prednisone 5 mg 63629-2264-01 Bryant 100 tablets — AB FDA listed —
prednisone 5 mg 64380-0783-01 Strides 100 tablets — AB FDA listed —
prednisone 5 mg 67046-1642-03 Coupler 30 tablets — AB FDA listed —
Prednisone 5 mg 67544-0399-60 Aphena 90 tablets — AB FDA listed —
PredniSONE 5 mg 68071-3581-01 NuCare 100 tablets — AB FDA listed —
Prednisone 5 mg 68071-3729-01 NuCare 21 tablets — AB FDA listed —
Prednisone 5 mg 68071-3742-01 NuCare 100 tablets — AB FDA listed —
prednisone 5 mg 68788-8579-03 Preferred 30 tablets — — FDA listed —
Prednisone 5 mg 68788-9551-02 Preferred 21 tablets — AB FDA listed —
Prednisone 5 mg 70518-3537-00 REMEDYREPACK 21 tablets — AB FDA listed —
prednisone 5 mg 70518-3539-00 REMEDYREPACK 30 tablets — AB Discontinued —
PredniSONE 5 mg 70518-4271-00 REMEDYREPACK 100 tablets — AB FDA listed —
Prednisone 5 mg 70882-0117-21 Cambridge 21 tablets — AB Discontinued —
Prednisone 5 mg 71335-0508-00 Bryant 42 tablets — AB Discontinued —
Prednisone 5 mg 71335-1780-00 Bryant 42 tablets — AB FDA listed —
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 71335-3042-01 Bryant 100 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 72189-0593-21 Direct_Rx 21 tablets — — FDA listed —
Prednisone 5 mg 72789-0413-21 PD-Rx 21 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 72789-0474-01 PD-Rx 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 5 mg 72789-0498-30 PD-Rx 30 tablets — AB FDA listed —
Prednisone 5 mg 76420-0067-21 Asclemed 21 tablets — AB FDA listed —
Prednisone 5 mg 80425-0068-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 80425-0069-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 80425-0106-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 80425-0479-01 Advanced 21 tablets — AB FDA listed —
PredniSONE 5 mg 80425-0480-01 Advanced 21 tablets — AB FDA listed —
PredniSONE 5 mg 80425-0481-01 Advanced 21 tablets — AB FDA listed —
prednisone 5 mg 80425-0482-01 Advanced 21 tablets — AB FDA listed —
Prednisone 5 mg 82804-0223-10 Proficient 10 tablets — AB FDA listed —
Prednisone 5 mg 87063-0043-01 ASCLEMED 100 tablets — AB FDA listed —
prednisone 5 mg 42708-0186-21 QPharma 21 tablets — AB FDA listed —
Prednisone 5 mg 61919-0365-21 DIRECT 21 tablets — AB FDA listed —
Prednisone 5 mg 70518-0305-00 REMEDYREPACK 21 tablets — AB FDA listed —
Prednisone 5 mg 66267-0172-06 NuCare 6 tablets — AB FDA listed —
Prednisone 5 mg 63629-2261-01 Bryant 21 tablets — AB Discontinued —
Prednisone 5 mg 50090-0439-00 A-S 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

🏛️
2002
On the market since
Jul 2002
📍
2026
Currently FDA-listed
24 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
63187-0066-05 5 TABLET in 1 BOTTLE (63187-066-05) 2014-08-01 Active
63187-0066-06 6 TABLET in 1 BOTTLE (63187-066-06) 2014-08-01 Active
63187-0066-08 8 TABLET in 1 BOTTLE (63187-066-08) 2014-08-01 Active
63187-0066-09 9 TABLET in 1 BOTTLE (63187-066-09) 2014-08-01 Active
63187-0066-12 12 TABLET in 1 BOTTLE (63187-066-12) 2014-08-01 Active
63187-0066-15 15 TABLET in 1 BOTTLE (63187-066-15) 2014-08-01 Active
63187-0066-20 20 TABLET in 1 BOTTLE (63187-066-20) 2014-08-01 Active
63187-0066-21 21 TABLET in 1 BOX, UNIT-DOSE (63187-066-21) 2014-08-01 Active
63187-0066-24 24 TABLET in 1 BOTTLE (63187-066-24) 2014-08-01 Active
63187-0066-30 30 TABLET in 1 BOTTLE (63187-066-30) 2014-08-01 Active
63187-0066-40 You're viewing this 40 TABLET in 1 BOTTLE (63187-066-40) 2014-08-01 Active
63187-0066-42 42 TABLET in 1 BOTTLE (63187-066-42) 2014-08-01 Active

You're viewing one of 12 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 63187-0066-40?
NDC 63187-0066-40 is a 40-count package — 40 tablet in 1 bottle.
What is the difference between NDC 63187-0066-40 and NDC 63187-0066-05?
Both are Prednisone 5 mg Tablet — the drug itself is identical. NDC 63187-0066-40 is the 40-count package, while NDC 63187-0066-05 is the 5 tablets package.
What NDC number is used to bill for this package of Prednisone 5 mg Tablet?
Bill NDC 63187-0066-40 — the 11-digit billing format is 63187006640. 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 63187-066-40, 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: 63187-0066-40, written without dashes as 63187006640. 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 63187-0066-40, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0066) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (40) 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 Proficient Rx LP. 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 11 other package presentations of this same product, including 5 tablets (63187-0066-05), 6 tablets (63187-0066-06), 8 tablets (63187-0066-08). 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?
Proficient Rx LP 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 ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🎯 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 Nonsuppurative thyroiditis Hypercalcemia associated with cancer • 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 Aspiration pneumonitis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy • 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 • 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 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 (…

⛔ Contraindications 14 words ▾

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

⚠️ Warnings ~2 min read ▾

WARNINGS 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 fulminating…

🤒 Adverse Reactions ~2 min read ▾

ADVERSE REACTIONS (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 treatme…

🔄 Drug Interactions ~2 min read ▾

Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure. Antibiotics Macrolide antibiotics have been reported to cause a significant decrease in corticosteroid clearance (see PRECAUTIONS: Drug Interactions: Hepatic Enzyme Inducers, Inhibitors and Substrates ).

Anticholinesterases Concomitant use of anticholinesterase agents (e.g., neostigmine, pyridostigmine ) and corticosteroids may produce severe weakness in patients with myasthenia gravis. If possible, anticholinesterase agents should be withdrawn at least 24 hours before initiating corticosteroid therapy. If concomitant therapy must occur, it should take place under close supervision and the need for respiratory support should be anticipated.

Anticoagulants, Oral Co-administration of corticosteroids and warfarin usually results in inhibition of response to warfarin, although there have been some conflicting reports. Therefore, coagulation indices should be monitored frequently to maintain the desired anticoagulant effect. Antidiabetics Because corticosteroids may increase blood glucose concentrations, dosage adjustments of antidiabetic agents may be required.

Antitubercular drugs Serum concentrations of isoniazid may be decreased. Bupropion Since systemic steroids, as well as bupropion, can lower the seizure threshold, concurrent administration should be undertaken only with extreme caution; low initial dosing and small gradual increases should be employed. Cholestyramine Cholestyramine may increase the clearance of corticosteroids.

Cyclosporine Increased activity of both cyclosporine and corticosteroids may occur when the two are used concurrently. Convulsions have been reported with this concurrent use. Digitalis Glycosides Patients on digitalis glycosides may be at increased risk of arrhythmias due to hypokalemia.

Estrogens, Including Oral Contraceptives Estrogens may decrease the hepatic metabolism of certain corticosteroids, thereby increasing their effect. Fluoroquinolones Post-marketing surveillance reports indicate that the risk of tendon rupture may be increased in patients receiving concomitant fluoroquinolones (e.g., ciprofloxacin, levofloxacin ) and corticosteroids, especially in the elderly. Tendon rupture can occur during or after treatment with quinolones.

Hepatic Enzyme Inducers, Inhibitors and Substrates Drugs which induce cytochrome P450 3A4 (CYP 3A4) enzyme activity (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance the metabolism of corticosteroids and require that the dosage of the corticosteroid be increased. Drugs which inhibit CYP 3A4 (e.g., ketoconazole, itraconazole, ritonavir, indinavir, macrolide antibiotics such as erythromycin ) have the potential to result in increased plasma concentrations of corticosteroids. Glucocorticoids are moderate inducers of CYP 3A4.

Co-administration with other drugs that are metabolized by CYP 3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration. Ketoconazole Ketoconazole has been reported to decrease the metabolism of certain corticosteroids by up to 60%, leading to increased risk of corticosteroid side effects. In addition, ketoconazole alone can inhibit adrenal corticosteroid synthesis and may cause adrenal insufficiency during corticosteroid withdrawal.

Nonsteroidal Anti-Inflammatory Agents (NSAIDS) Concomitant use of aspirin (or other nonsteroidal anti-inflammatory agents ) and corticosteroids increases the risk of gastrointestinal side effects. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia. The clearance of salicylate…

🤰 Pregnancy 99 words ▾

Pregnancy Teratogenic Effects Pregnancy Category C Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Animal studies in which corticosteroids have been given to pregnant mice, rats, and rabbits have yielded an increased incidence of cleft palate in the offspring. There are no adequate and well-controlled studies in pregnant women.

Corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Infants born to mothers who have received substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism.

🧒 Pediatric Use ~1 min read ▾

Pediatric Use The efficacy and safety of corticosteroids in the pediatric population are based on the well-established course of effect of corticosteroids, which is similar in pediatric and adult populations. Published studies provide evidence of efficacy and safety in pediatric patients for the treatment of nephrotic syndrome (patients >2 years of age), and aggressive lymphomas and leukemias (patients >1 month of age). Other indications for pediatric use of corticosteroids, e.g., severe asthma and wheezing, are based on adequate and well-controlled trials conducted in adults, on the premises that the course of the diseases and their pathophysiology are considered to be substantially similar in both populations.

The adverse effects of corticosteroids in pediatric patients are similar to those in adults (see ADVERSE REACTIONS ). Like adults, pediatric patients should be carefully observed with frequent measurements of blood pressure, weight, height, intraocular pressure, and clinical evaluation for the presence of infection, psychosocial disturbances, thromboembolism, peptic ulcers, cataracts, and osteoporosis. Pediatric patients who are treated with corticosteroids by any route, including systemically administered corticosteroids, may experience a decrease in their growth velocity.

This negative impact of corticosteroids on growth has been observed at low systemic doses and in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression (i.e., cosyntropin stimulation and basal cortisol plasma levels). Growth velocity may therefore be a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function. The linear growth of pediatric patients treated with corticosteroids should be monitored, and the potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of treatment alternatives.

In order to minimize the potential growth effects of corticosteroids, pediatric patients should be titrated to the lowest effective dose.

🧓 Geriatric Use 101 words ▾

Geriatric Use Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

In particular, the increased risk of diabetes mellitus, fluid retention and hypertension in elderly patients treated with corticosteroids should be considered.

🧬 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 197 words ▾

HOW SUPPLIED PredniSONE Tablets are available in the following strengths and package sizes: 5 mg (white, round, scored, debossed “5094” on one side and debossed “V” on the reverse side) • Bottles of 05 NDC 63187-066-05 • Bottles of 06 NDC 63187-066-06 • Bottles of 08 NDC 63187-066-08 • Bottles of 09 NDC 63187-066-09 • Bottles of 12 NDC 63187-066-12 • Bottles of 15 NDC 63187-066-15 • Bottles of 20 NDC 63187-066-20 • Unit-of-Use (21 Tablets) NDC 63187-066-21 • Bottles of 24 NDC 63187-066-24 • Bottles of 30 NDC 63187-066-30 • Bottles of 40 NDC 63187-066-40 • Bottles of 42 NDC 63187-066-42 10 mg (white, round, scored, debossed “5093” on one side and debossed “V” on the reverse side) • Bottles of 05 NDC 63187-037-05 • Bottles of 08 NDC 63187-037-08 • Bottles of 09 NDC 63187-037-09 • Bottles of 10 NDC 63187-037-10 • Bottles of 20 NDC 63187-037-20 • Unit-of-Use (21 Tablets) NDC 63187-037-21 • Bottles of 30 NDC 63187-037-30 • Bottles of 40 NDC 63187-037-40 • Bottles of 42 NDC 63187-037-42 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].

📦 Storage and Handling 24 words ▾

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].

📋 Description 174 words ▾

DESCRIPTION Click here to enter Description

DESCRIPTION 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: 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.

This is an image of the formula for PredniSONE.

💬 Information for Patients 116 words ▾

Information for Patients Patients should be warned not to discontinue the use of corticosteroids abruptly or without medical supervision. As prolonged use may cause adrenal insufficiency and make patients dependent on corticosteroids, they should advise any medical attendants that they are taking corticosteroids and they should seek medical advice at once should they develop an acute illness including fever or other signs of infection. Following prolonged therapy, withdrawal of corticosteroids may result in symptoms of the corticosteroid withdrawal syndrome including, myalgia, arthralgia, and malaise.

Persons who are on corticosteroids should be warned to avoid exposure to chickenpox or measles. Patients should also be advised that if they are exposed, medical advice should be sought without delay.

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