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Prednisone 20 mg Tablet, 20-count — NDC 76420-0069-20 package photo

Prednisone 20 mg Tablet, 20-count

by Asclemed USA, Inc. · 20 TABLET in 1 BOTTLE (76420-069-20)
NDC 76420-0069-20
🏷️ FDA NDC (as labeled) 76420-069-20 billing pads the product segment with a zero
This package
Contains20-count Pack sizes5 compare ↓
Also priced by: Part D plans $0.2837/unit — full pricing hub ↓
Also comes in: 10 tablets 76420-0069-10 15 tablets 76420-0069-15 21 tablets 76420-0069-21 30 tablets 76420-0069-30
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) 76420-069-20
Product NDC 76420-069
11-digit billing NDC 76420006920
NCPDP billing unit EA — each (per item)
RxCUI 198145, 312615, 312617
UNII VB0R961HZT
Application # ANDA040362
SPL Set ID dc663fd3-b149-48ae-a3f3-6abaa4808cc6
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 2001-08-29
Route ORAL
Dosage form TABLET
Substance PREDNISONE
GPI-14 22100045000325
GPI class predniSONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 76420-069-20 — 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 → 76420-0069-20. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids acting locally, Glucocorticoids
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAsclemed USA, Inc.
Application holderJUBILANT CADISTA PHARMACEUTICALS INC
FDA applicationANDA040362 (ANDA)
Labeler code76420
First marketedAug 2001
Product typeHuman Prescription Drug
Portfolio652 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 / pink
ShapeRound
ImprintTL175
Size11 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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

  • UNII LMI26O6933
    Alumina is a white powder form of aluminum oxide. It's used as a filler to add bulk to tablets and capsules, and sometimes as a thickening or anti-caking agent in powdered formulations.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • 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 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • 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 8I089SAH3T
    A carbohydrate powder extracted from potatoes. It serves as a filler to add bulk and volume to the tablet or capsule, and as a disintegrant to help the medicine break apart and release its active ingredient in your body.

7 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 $5.67 / 20 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 20 mg 00378-0642-01 Mylan 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 00591-5443-01 Actavis 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 00603-5339-21 Par 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 59651-0488-01 Aurobindo 100 tablets $0.064 AB Availability likely —
prednisone 20 mg 60219-1708-01 Amneal 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 60687-0145-01 American 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 60687-0925-01 American 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 62135-0553-30 Chartwell 30 tablets $0.064 BX Availability likely —
PredniSONE Tablets, USP, 20 mg 63561-0122-01 Granulation 100 tablets $0.064 AB Availability likely —
Prednisone 20 mg 70954-0060-10 ANI 100 tablets $0.064 AB Availability likely —
PredniSONE 20 mg 00054-0018-20 Hikma 100 tablets $0.092 AB FDA listed —
PredniSONE 20 mg 00054-9818-25 Hikma 100 tablets — AB FDA listed —
prednisone 20 mg 00615-8441-39 NCS 30 tablets — AB FDA listed —
Prednisone 20 mg 10135-0778-01 Marlex 100 tablets — AB FDA listed —
Prednisone 20 mg 42708-0105-10 QPharma, 10 tablets — AB FDA listed —
Prednisone 20 mg 42708-0195-10 QPharma, 10 tablets — AB FDA listed —
prednisone 20 mg 45865-0884-21 Medsource 21 tablets — AB FDA listed —
Prednisone 20 mg 50090-2786-00 A-S 21 tablets — AB Discontinued —
Prednisone 20 mg 50090-2789-01 A-S 10 tablets — AB FDA listed —
Prednisone 20 mg 50090-2804-00 A-S 20 tablets — AB FDA listed —
prednisone 20 mg 50090-6122-01 A-S 10 tablets — AB FDA listed —
prednisone 20 mg 50090-6123-00 A-S 20 tablets — AB FDA listed —
prednisone 20 mg 50090-6259-00 A-S 21 tablets — AB FDA listed —
Prednisone 20 mg 51407-0923-05 Golden 500 tablets — AB FDA listed —
Prednisone 20 mg 51655-0242-53 Northwind 10 tablets — AB FDA listed —
prednisone 20 mg 51655-0541-20 Northwind 20 tablets — AB FDA listed —
PredniSONE 20 mg 51655-0701-18 Northwind 18 tablets — — FDA listed —
Prednisone 20 mg 55154-2147-00 Cardinal 10 tablets — AB FDA listed —
Prednisone 20 mg 55154-2581-00 Cardinal 10 tablets — AB FDA listed —
prednisone 20 mg 60760-0790-12 St. 12 tablets — AB FDA listed —
Prednisone 20 mg 60760-0797-12 St. 12 tablets — AB FDA listed —
Prednisone 20 mg 60760-0840-12 ST. 12 tablets — AB FDA listed —
Prednisone 20 mg 63187-0807-05 Proficient 5 tablets — AB FDA listed —
prednisone 20 mg 64380-0785-01 Strides 100 tablets — AB FDA listed —
Prednisone 5 mg 66267-0172-06 NuCare 6 tablets — AB FDA listed —
Prednisone 20 mg 66267-0860-03 NuCare 3 tablets — AB FDA listed —
Prednisone 20 mg 67046-1610-03 Coupler 30 tablets — AB FDA listed —
prednisone 20 mg 67296-2081-01 Redpharm 10 tablets — AB FDA listed —
Prednisone 20 mg 67296-2182-01 Redpharm 10 tablets — AB FDA listed —
Prednisone 20 mg 68071-3143-01 NuCare 100 tablets — AB FDA listed —
Prednisone 20 mg 68071-3617-01 NuCare 10 tablets — AB FDA listed —
Prednisone 20 mg 68071-3637-01 NuCare 10 tablets — AB FDA listed —
Prednisone 20 mg 68071-3721-00 NuCare 10 tablets — AB FDA listed —
Prednisone 20 mg 68071-3738-01 NuCare 10 tablets — AB FDA listed —
Prednisone 20 mg 68071-4685-02 NuCare 21 tablets — AB FDA listed —
prednisone 20 mg 68788-8663-01 Preferred 10 tablets — AB FDA listed —
Prednisone 20 mg 68788-8819-01 Preferred 10 tablets — AB FDA listed —
prednisone 20 mg 70518-3401-00 REMEDYREPACK 34 tablets — AB Discontinued —
prednisone 20 mg 70518-3540-00 REMEDYREPACK 30 tablets — AB FDA listed —
Prednisone 20 mg 70518-4243-00 REMEDYREPACK 30 tablets — AB FDA listed —
prednisone 20 mg 70518-4293-00 REMEDYREPACK 10 tablets — AB FDA listed —
Prednisone 20 mg 71205-0239-05 Proficient 5 tablets — AB FDA listed —
Prednisone 20 mg 71205-0407-10 Proficient 10 tablets — AB FDA listed —
prednisone 20 mg 71205-0741-06 Proficient 6 tablets — AB FDA listed —
prednisone 20 mg 71205-0797-10 Proficient 10 tablets — AB FDA listed —
Prednisone 20 mg 71335-0623-00 Bryant 11 tablets — AB Discontinued —
prednisone 20 mg 71335-2079-00 Bryant 11 tablets — AB FDA listed —
prednisone 20 mg 71335-2149-01 Bryant 6 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 71335-2737-00 Bryant 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 71335-2754-00 Bryant 11 tablets — AB FDA listed —
prednisone 20 mg 71335-2895-01 Bryant 9 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 71335-2938-01 Bryant 9 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 71335-3046-01 Bryant 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 71335-3047-01 Bryant 1000 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 72162-2486-00 Bryant 1000 tablets — AB FDA listed —
Prednisone 20 mg 72189-0430-05 Direct_Rx 5 tablets — AB FDA listed —
Prednisone 20 mg 72789-0393-02 PD-Rx 2 tablets — AB FDA listed —
Prednisone 20 mg 72789-0448-21 PD-Rx 21 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 72789-0473-01 PD-Rx 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 72789-0500-21 PD-Rx 21 tablets — AB FDA listed —
PredniSONE Tablets, USP, 20 mg 72789-0509-06 PD-Rx 6 tablets — AB FDA listed —
Prednisone 20 mgthis 76420-0069-20 Asclemed 20 tablets — AB FDA listed —
prednisone 20 mg 76420-0413-00 Asclemed 1000 tablets — AB FDA listed —
Prednisone 20 mg 80425-0105-01 Advanced 20 tablets — AB FDA listed —
Prednisone 20 mg 80425-0486-01 Advanced 21 tablets — AB FDA listed —
prednisone 20 mg 80425-0487-01 Advanced 21 tablets — AB FDA listed —
P- Pack Prednisone 20Mg, 7- Day Tapering Dose Pack 20 mg 85000-0012-01 INTERSTELLAR 15 tablets — AB Discontinued —
prednisone 20 mg 85766-0002-00 Sportpharm 1000 tablets — AB FDA listed —
Prednisone 20 mg 87063-0045-01 ASCLEMED 100 tablets — AB FDA listed —
PredniSONE 20 mg 68788-4182-01 Preferred 10 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

🏛️
2001
On the market since
Aug 2001
📍
2026
Currently FDA-listed
25 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
76420-0069-10 10 TABLET in 1 BOTTLE (76420-069-10) 2020-08-28 Active
76420-0069-15 15 TABLET in 1 BOTTLE (76420-069-15) 2020-08-28 Active
76420-0069-20 You're viewing this 20 TABLET in 1 BOTTLE (76420-069-20) 2020-08-28 Active
76420-0069-21 21 TABLET in 1 BOTTLE (76420-069-21) 2020-08-28 Active
76420-0069-30 30 TABLET in 1 BOTTLE (76420-069-30) 2020-08-28 Active

You're viewing one of 5 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 76420-0069-20?
NDC 76420-0069-20 is a 20-count package — 20 tablet in 1 bottle.
What is the difference between NDC 76420-0069-20 and NDC 76420-0069-10?
Both are Prednisone 20 mg Tablet — the drug itself is identical. NDC 76420-0069-20 is the 20-count package, while NDC 76420-0069-10 is the 10 tablets package.
What NDC number is used to bill for this package of Prednisone 20 mg Tablet?
Bill NDC 76420-0069-20 — the 11-digit billing format is 76420006920. 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 76420-069-20, 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: 76420-0069-20, written without dashes as 76420006920. 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 76420-0069-20, the first segment (76420) is the labeler code FDA assigned to Asclemed USA, Inc.; the middle segment (0069) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (20) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Asclemed USA, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 10 tablets (76420-0069-10), 15 tablets (76420-0069-15), 21 tablets (76420-0069-21). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Asclemed USA, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage ~2 min read ▾

INDICATIONS Prednisone Tablets, USP are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis.

3. Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic derznatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5.

Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6. Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7.

Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy. Aspiration pneumonitis 8. Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9.

Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus 11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12.

Nervous System Acute exacerbations of multiple sclerosis 13. Miscellaneous Tuberculous meningitis with subarachnoid block or, impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The initial dosage of prednisone Tablets, USP may vary from 5 mg to 60 mg prednisone per day depending on the specific disease entity being treated. In situations of less severity lower doses will generally suffice while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted.

If after a reasonable period of time there is a lack of satisfactory clinical response, Prednisone should be discontinued and the patient transferred to other appropriate therapy. IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

It should be kept in mind that constant monitoring is needed in regard to drug dosage. Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation it may be necessary to increase the dosage of Prednisone for a period of time consistent with the patient’s condition.

If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly. Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) ADT ® (Alternate Day Therapy) ADT is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning.

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

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

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

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

⛔ Contraindications 9 words ▾

CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.

⚠️ Warnings ~2 min read ▾

WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. Corticosteroids may mask some signs of infection, and new infections may appear during their use. There may be decreased resistance and inability to localize infection when corticosteroids are used.

Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to fungi or viruses. Usage in pregnancy: Since adequate human reproduction studies have not been done with corticosteroids, the use of these drugs in pregnancy, nursing mothers or women of childbearing potential requires that the possible benefits of the drug be weighed against the potential hazards to the mother and embryo or fetus.

Infants born of mothers who have received substantial doses of corticosteroids during pregnancy, should be carefully observed for signs of hypoadrenalism. 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. While on corticosteroid therapy patients should not be vaccinated against smallpox.

Other immunization procedures should not be undertaken in patients who are on corticosteroids, especially on high dose, because of possible hazards of neurological complications and a lack of antibody response. The use of Prednisone Tablets, USP in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate anti-tuberculous regimen. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur.

During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis. Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteroids.

In such children or adults who have not had these diseases, particular care should be taken to avoid exposure. How the dose, route and duration of corticosteroid administration affects the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.

If exposed to chickenpox, prophylaxis with varicella-zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

🤒 Adverse Reactions 166 words ▾

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Metabolic Negative nitrogen balance due to protein catabolism Neurological Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Suppression of growth in children Decreased carbohydrate tolerance Manifestations of latent diabetes melliltus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Additional Reactions Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

🧬 Clinical Pharmacology 56 words ▾

ACTIONS 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 205 words ▾

HOW SUPPLIED Prednisone Tablets, USP are available in the following strengths and package sizes: 5 mg (White, round tablets debossed with "TL 172" on one side and scored on the other side) Bottles of 21 NDC 76420-067-21 (repackaged from NDC 59746-172-06) Bottles of 30 NDC 76420-067-30 (repackaged from NDC 59746-172-06) Bottles of 48 NDC 76420-067-48 (repackaged from NDC 59746-172-06) 10 mg (White, round tablets debossed with "TL 173" on one side and scored on the other side) Bottles of 20 NDC 76420-068-20 (repackaged from NDC 59746-173-06) Bottles of 21 NDC 76420-068-21 (repackaged from NDC 59746-173-06) Bottles of 30 NDC 76420-068-30 (repackaged from NDC 59746-173-06) Bottles of 40 NDC 76420-068-40 (repackaged from NDC 59746-173-06) Bottles of 60 NDC 76420-068-60 (repackaged from NDC 59746-173-06) 20mg (Peach, round tablets debossed with "TL 175" on one side and scored on the other side) Bottles of 10 NDC 76420-069-10 (repackaged from NDC 59746-175-06) Bottles of 15 NDC 76420-069-15 (repackaged from NDC 59746-175-06) Bottles of 20 NDC 76420-069-20 (repackaged from NDC 59746-175-06) Bottles of 21 NDC 76420-069-21 (repackaged from NDC 59746-175-06) Bottles of 30 NDC 76420-069-30 (repackaged from NDC 59746-175-06) Store at 20° to 25° C (68° to 77° F) [See USP Room Temperature].

Repackaged by: Enovachem PHARMACEUTICALS Torrance, CA 90501

📋 Description 125 words ▾

DESCRIPTION Prednisone 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, in chloroform, in dioxane, and in methanol. The chemical name for prednisone is pregna-1, 4-diene-3, 11, 20-trione, 17, 21-dihydroxy- The structural formula is represented below: Molecular weight: 358.44 Prednisone Tablets, USP are available in three strengths: 5 mg, 10 mg, and 20 mg. In addition, each tablet contains the following Inactive Ingredients: Lactose Monohydrate, Magnesium Stearate, Pregelatinized Starch, Sodium Lauryl Sulfate and Sodium Starch Glycolate.

Also Prednisone Tablets USP, 20 mg contains FD & C yellow #6 aluminum lake HT 15-18%. Image

💬 Information for Patients 38 words ▾

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

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 76420-0068-20 · Asclemed 76420-0072-10 · Asclemed →
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.