Home › NDC Lookup › Ingredients › Prednisone › 67296-0140-01
Prednisone 10 mg Tablet, 10-count — NDC 67296-0140-01 package photo

Prednisone 10 mg Tablet, 10-count

by Redpharm Drug · 10 TABLET in 1 BOTTLE (67296-0140-1)
NDC 67296-0140-01
🏷️ FDA NDC (as labeled) 67296-0140-1 billing pads the package segment with a zero
This package
Contains10-count Pack sizes5 compare ↓
Also comes in: 4 tablets 67296-0140-04 9 tablets 67296-0140-09 30 tablets 67296-0140-02 42 tablets 67296-0140-03
Rx only Generic Discontinued Non-controlled ⚠ Inactivated by FDA
🗂️ Data synced Sep 17, 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

⚠️
Excluded from the active FDA NDC Directory. FDA inactivated this product’s listing record, so it is excluded from the active NDC Directory. The listing was last certified through Dec 2025. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 67296-0140-1
Product NDC 67296-0140
11-digit billing NDC 67296014001
RxCUI 198145
UNII VB0R961HZT
Application # ANDA085162
SPL Set ID c8bc83d5-b9e2-4d31-a3df-8e899aac1ba5
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Inactivated by FDA (certified through Dec 2025)
Marketing start 1990-01-01
Route ORAL
Dosage form TABLET
Substance PREDNISONE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 67296-0140-1 — a 5-4-1 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 package segment → 67296-0140-01. 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

LabelerRedpharm Drug
Application holderWATSON LABORATORIES INC
FDA applicationANDA085162 (ANDA)
Labeler code67296
First marketedJan 1990
Product typeHuman Prescription Drug
Portfolio250 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

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

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

🧪 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
ImprintDAN;DAN;5442
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII 68401960MK
    Crospovidone is a synthetic polymer made from polyvinylpyrrolidone. It acts as a disintegrant, helping tablets break apart quickly in the stomach so the medicine dissolves and absorbs into the body.
  • UNII F05Q2T2JA0
    Docusate sodium is a stool softener compound that helps medicines dissolve and move through the digestive tract. It acts as a surfactant, reducing surface tension in the intestines, and also serves as a wetting agent in tablet formulations.
  • 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 OJ245FE5EU
    Sodium benzoate is a salt derived from benzoic acid, a preservative. It's added to medicines to prevent growth of bacteria, fungi, and other microorganisms that could spoil the product.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 4 tablets 9 tablets 30 tablets 42 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 10 mg 00054-9817-25 Hikma 100 tablets $0.056 AB Availability likely —
Prednisone 10 mg 00378-0641-01 Mylan 100 tablets $0.056 — Availability likely —
Prednisone 10 mg 00591-5442-01 Actavis 100 tablets $0.056 — Availability likely —
Prednisone 10 mg 00904-6923-61 Major 100 tablets $0.056 AB Availability likely —
Prednisone 10 mg 59651-0487-01 Aurobindo 100 tablets $0.056 AB Availability likely —
prednisone 10 mg 60219-1707-01 Amneal 100 tablets $0.056 AB Availability likely —
Prednisone 10 mg 60687-0134-01 American 100 tablets $0.056 AB Availability likely —
Prednisone 10 mg 60687-0914-01 American 100 tablets $0.056 AB Availability likely —
PredniSONE Tablets, USP, 10 mg 63561-0121-01 Granulation 100 tablets $0.056 AB Availability likely —
Prednisone 10 mg 70954-0059-10 ANI 100 tablets $0.056 AB Availability likely —
PredniSONE 10 mg 00054-0017-20 Hikma 100 tablets $0.060 AB FDA listed —
Prednisone 10 mg 00603-5338-15 Par 21 tablets $0.573 AB Availability likely —
prednisone 10 mg 00615-8440-05 NCS 15 tablets — AB FDA listed —
Prednisone 10 mg 10135-0777-01 Marlex 100 tablets — AB FDA listed —
PredniSONE 10 mg 42708-0045-21 QPharma, 21 tablets — — FDA listed —
Prednisone 10 mg 42708-0115-21 QPharma, 21 tablets — AB FDA listed —
prednisone 10 mg 42708-0166-21 QPharma 21 tablets — AB FDA listed —
Prednisone 10 mg 50090-3137-00 A-S 10 tablets — AB FDA listed —
Prednisone 10 mg 50090-5202-00 A-S 60 tablets — AB FDA listed —
Prednisone 10 mg 50090-7023-00 A-S 100 tablets — AB FDA listed —
Prednisone 10 mg 50090-7024-00 A-S 10 tablets — AB FDA listed —
Prednisone 10 mg 50090-7025-00 A-S 60 tablets — AB FDA listed —
prednisone 10 mg 50090-7218-00 A-S 10 tablets — AB FDA listed —
prednisone 10 mg 50090-7219-00 A-S 60 tablets — AB FDA listed —
prednisone 10 mg 50090-7369-00 A-S 10 tablets — AB FDA listed —
prednisone 10 mg 50090-7371-00 A-S 60 tablets — AB FDA listed —
Prednisone 10 mg 51407-0922-10 Golden 1000 tablets — — FDA listed —
Prednisone 10 mg 51655-0410-20 Northwind 20 tablets — AB FDA listed —
PredniSONE 10 mg 51655-0493-49 Northwind 42 tablets — — FDA listed —
Prednisone 10 mg 51655-0935-20 Northwind 20 tablets — — FDA listed —
Prednisone 10 mg 54348-0506-10 PharmPak, 10 tablets — AB FDA listed —
Prednisone 10 mg 55154-3564-00 Cardinal 10 tablets — AB FDA listed —
Prednisone 10 mg 63187-0037-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 63187-0300-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 63629-2257-01 Bryant 1000 tablets — AB FDA listed —
prednisone 10 mg 64380-0784-01 Strides 100 tablets — AB FDA listed —
Prednisone 10 mg 66267-0171-15 NuCare 15 tablets — AB FDA listed —
Prednisone 10 mg 66267-0812-10 NuCare 100 tablets — AB FDA listed —
prednisone 10 mg 67046-1579-03 Coupler 30 tablets — AB FDA listed —
Prednisone 10 mgthis 67296-0140-01 Redpharm 10 tablets — AB Discontinued —
Prednisone 10 mg 68071-2661-00 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3641-01 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3746-00 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3821-03 NuCare 30 tablets — AB FDA listed —
prednisone 10 mg 68788-8166-02 Preferred 21 tablets — AB FDA listed —
prednisone 10 mg 70518-3476-00 REMEDYREPACK 21 tablets — AB Discontinued —
prednisone 10 mg 70518-4038-00 REMEDYREPACK 48 tablets — AB FDA listed —
PredniSONE 10 mg 70518-4191-01 REMEDYREPACK 30 tablets — — FDA listed —
prednisone 10 mg 70518-4354-00 REMEDYREPACK 30 tablets — AB FDA listed —
Prednisone 10 mg 70518-4560-00 REMEDYREPACK 18 tablets — AB FDA listed —
prednisone 10 mg 70518-4660-00 REMEDYREPACK 14 tablets — AB FDA listed —
Prednisone 10 mg 71205-0362-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 71205-0421-10 Proficient 10 tablets — AB FDA listed —
prednisone 10 mg 71205-0729-10 Proficient 10 tablets — AB FDA listed —
prednisone 10 mg 71205-0818-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 71335-0335-00 Bryant 10 tablets — AB Discontinued —
prednisone 10 mg 71335-2069-00 Bryant 10 tablets — AB FDA listed —
prednisone 10 mg 71335-2122-01 Bryant 5 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-2736-00 Bryant 12 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-2752-00 Bryant 10 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-3044-01 Bryant 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-3045-01 Bryant 1000 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72162-2485-00 Bryant 1000 tablets — AB FDA listed —
Prednisone 10 mg 72189-0589-10 Direct_Rx 10 tablets — AB FDA listed —
Prednisone 10 mg 72789-0401-10 PD-Rx 10 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72789-0475-01 PD-Rx 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72789-0513-10 PD-Rx 10 tablets — AB FDA listed —
Prednisone 10 mg 76420-0068-20 Asclemed 20 tablets — AB FDA listed —
prednisone 10 mg 76420-0412-00 Asclemed 1000 tablets — AB FDA listed —
Prednisone 10 mg 80425-0193-01 Advanced 21 tablets — AB FDA listed —
prednisone 10 mg 80425-0484-01 Advanced 21 tablets — AB FDA listed —
PredniSONE 10 mg 80425-0485-01 Advanced 21 tablets — — FDA listed —
Prednisone 10 mg 80425-0491-01 Advanced 21 tablets — AB FDA listed —
prednisone 10 mg 85766-0001-00 Sportpharm 1000 tablets — AB FDA listed —
Prednisone 10 mg 87063-0044-01 ASCLEMED 100 tablets — AB FDA listed —
Prednisone 10 mg 50090-1001-00 A-S 21 tablets — AB FDA listed —
Prednisone 10 mg 50090-1002-00 A-S 48 tablets — AB Discontinued —
PredniSONE 10 mg 55289-0330-05 PD-Rx 5 tablets — — FDA listed —
prednisone 10 mg 51655-0972-20 Northwind 20 tablets — AB FDA listed —
PredniSONE 10 mg 51655-0726-21 Northwind 21 tablets — AB FDA listed —
prednisone 10 mg 87441-0069-01 Unit 30 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

🏛️
1990
On the market since
Jan 1990
📍
2026
Currently FDA-listed
36 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
67296-0140-01 You're viewing this 10 TABLET in 1 BOTTLE (67296-0140-1) 2020-04-22 Inactivated by FDA
67296-0140-02 30 TABLET in 1 BOTTLE (67296-0140-2) 2011-06-24 Inactivated by FDA
67296-0140-03 42 TABLET in 1 BOTTLE (67296-0140-3) 2020-04-22 Inactivated by FDA
67296-0140-09 9 TABLET in 1 BOTTLE (67296-0140-9) 2020-04-22 Inactivated by FDA
67296-0140-04 4 TABLET in 1 BOTTLE (67296-0140-4) 1990-01-01 Active

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

Pack size FAQ

What quantity is in NDC 67296-0140-01?
NDC 67296-0140-01 is a 10-count package — 10 tablet in 1 bottle.
What is the difference between NDC 67296-0140-01 and NDC 67296-0140-04?
Both are Prednisone 10 mg Tablet — the drug itself is identical. NDC 67296-0140-01 is the 10-count package, while NDC 67296-0140-04 is the 4 tablets package.
What NDC number is used to bill for this package of Prednisone 10 mg Tablet?
Bill NDC 67296-0140-01 — the 11-digit billing format is 67296014001. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 67296-0140-1, 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: 67296-0140-01, written without dashes as 67296014001. 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 67296-0140-01, the first segment (67296) is the labeler code FDA assigned to Redpharm Drug; the middle segment (0140) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 4 other package presentations of this same product, including 4 tablets (67296-0140-04), 9 tablets (67296-0140-09), 30 tablets (67296-0140-02). 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?
Redpharm Drug 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 🧬 Clinical Pharmacology 📦 How Supplied / 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; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic disorders: as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.

Collagen diseases: during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis), acute rheumatic carditis. Dermatologic diseases: pemphigus; bullous dermatitis herpetiformis; severe erythema multiforme (Stevens-Johnson syndrome); exfoliative dermatitis; mycosis fungoides; severe psoriasis; severe seborrheic dermatitis. Allergic states: control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: seasonal or perennial allergic rhinitis; bronchial asthma; contact dermatitis; atopic dermatitis; serum sickness; drug hypersensitivity reactions.

Ophthalmic diseases: severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic corneal marginal ulcers, herpes zoster ophthalmicus, anterior segment inflammation, diffuse posterior uveitis and choroiditis, sympathetic ophthalmia, allergic conjunctivitis, keratitis, chorioretinitis, optic neuritis, iritis and iridocyclitis. Respiratory diseases: symptomatic sarcoidosis; Loeffler’s syndrome not manageable by other means; berylliosis; fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy; aspiration pneumonitis.

Hematologic disorders: idiopathic thrombocytopenic purpura in adults; secondary thrombocytopenia in adults; acquired (autoimmune) hemolytic anemia; erythroblastopenia (RBC anemia); congenital (erythroid) hypoplastic anemia. Neoplastic diseases: for palliative management of: leukemias and lymphomas in adults, acute leukemia of childhood. Edematous states: to induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

Gastrointestinal diseases: to tide the patient over a critical period of the disease in: ulcerative colitis, regional enteritis. Nervous system: acute exacerbations of multiple sclerosis. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.

⏱️ Dosage and Administration ~3 min read ▾

DOSAGE AND ADMINISTRATION The initial dosage of prednisone 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 decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached.

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

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

The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children. The rationale for this treatment schedule is based on two major premises: (a) the antiinflammatory 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 durin…

⛔ Contraindications 14 words ▾

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

⚠️ Warnings ~3 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. Infections with any pathogen including viral, bacterial, fungal, protozoan or helminthic infections, 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 can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. 2 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. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids.

Killed or inactivated vaccines may be administered to patients receiving immunosuppressive doses of corticosteroids; however, the response to such vaccines may be diminished. Indicated immunization procedures may be undertaken in patients receiving nonimmunosuppressive doses of corticosteroids. The use of prednisone tablets 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 antituberculous 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.

Chicken pox 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 chicken pox, 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 chicken pox develops, treatment with antiviral agents may be considered. Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm)…

🤒 Adverse Reactions 208 words ▾

ADVERSE REACTIONS Fluid and electrolyte disturbances: sodium retention; fluid retention; congestive heart failure in susceptible patients; potassium loss; hypokalemic alkalosis; hypertension. Musculoskeletal: muscle weakness; steroid myopathy; loss of muscle mass; osteoporosis; tendon rupture, particularly of the Achilles tendon; vertebral compression fractures; aseptic necrosis of femoral and humeral heads; pathologic fracture of long bones. Gastrointestinal: peptic ulcer with possible perforation and hemorrhage; pancreatitis; abdominal distention; ulcerative esophagitis; increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT) and alkaline phosphatase have been observed following corticosteroid treatment.

These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic: impaired wound healing; thin fragile skin; petechiae and ecchymoses; facial erythema; increased sweating; may suppress reactions to skin tests. Metabolic: negative nitrogen balance due to protein catabolism.

Neurological: increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment; convulsions; vertigo; headache. Endocrine: menstrual irregularities; development of cushingoid state; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; suppression of growth in children; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements for insulin or oral hypoglycemic agents in diabetics.

Ophthalmic: posterior subcapsular cataracts; increased intraocular pressure; glaucoma; exophthalmos. Additional Reactions: urticaria and other allergic, anaphylactic or hypersensitivity reactions.

🔄 Drug Interactions 150 words ▾

Drug Interactions The pharmacokinetic interactions listed below are potentially clinically important. Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of corticosteroids and may require increases in corticosteroid dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of corticosteroids and thus decrease their clearance.

Therefore, the dose of corticosteroid should be titrated to avoid steroid toxicity. Corticosteroids may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when corticosteroid is withdrawn.

Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia. The effect of corticosteroids on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulants when given concurrently with corticosteroids.

Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

🧬 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 antiinflammatory 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 87 words ▾

HOW SUPPLIED Prednisone Tablets USP 5 mg are scored, round, white tablets imprinted DAN DAN and 5052 supplied in bottles of 100 and 1000. Prednisone Tablets USP 10 mg are scored, round, white tablets imprinted DAN DAN and 5442 supplied in bottles of 100, 500 and 1000. Prednisone Tablets USP 20 mg are scored, round, peach tablets imprinted DAN DAN and 5443 supplied in bottles of 100, 500 and 1000.

Dispense in a well-closed container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.]

📋 Description 119 words ▾

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. 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 is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg of prednisone USP (anhydrous).

In addition, each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, crospovidone, docusate sodium, magnesium stearate and sodium benzoate. Prednisone Tablets USP 20 mg also contain FD and C Yellow No. 6.

STRUCTURE

💬 Information for Patients 39 words ▾

Information for Patients Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chicken pox 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 ↗
← 67296-0078-01 · Redpharm 67296-0142-01 · Redpharm →
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.