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PREDNISONE 1 mg Tablet, 100-count — NDC 59651-0484-01 package photo

PREDNISONE 1 mg Tablet, 100-count

by Aurobindo Pharma Limited · 100 TABLET in 1 BOTTLE (59651-484-01)
NDC 59651-0484-01
🏷️ FDA NDC (as labeled) 59651-484-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.0414 NADAC Per package$4.14 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.1189/unit · Part D plans $0.2837/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 59651-484-01
Product NDC 59651-484
11-digit billing NDC 59651048401
NCPDP billing unit EA — each (per item)
RxCUI 198144
UNII VB0R961HZT
Application # ANDA215671
SPL Set ID 7b33767f-a520-4470-8f3f-4e86b38d615a
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 2021-11-16
Route ORAL
Dosage form TABLET
Substance PREDNISONE
GPI-14 22100045000305
GPI class predniSONE
GCN Seq No 006748
GCN 27171
HICL code 002879
Ingredient (HICL) Prednisone
HIC1 code P
Therapeutic class — broad (HIC1) Endocrine System
HIC2 code P5
Therapeutic class — intermediate (HIC2) Adrenocortical Hormones
HIC3 code P5A
Therapeutic class — specific (HIC3) Glucocorticoids
AHFS code 68:04.00.00
AHFS class Adrenals
FDB label name PREDNISONE 1 MG TABLET
FDB brand name Prednisone
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 59651-484-01 — 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 → 59651-0484-01. 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

LabelerAurobindo Pharma Limited
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA215671 (ANDA)
Labeler code59651
First marketedNov 2021
Product typeHuman Prescription Drug
Portfolio1,452 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PREDNISONE 1 MG TABLET Ingredient Prednisone
📖 What it is MedlinePlus · NLM

Prednisone is used alone or with other medications to treat the symptoms of low corticosteroid levels (lack of certain substances that are usually produced by the body and are needed for normal body functioning). Prednisone is also used to treat other conditions in patients with normal corticosteroid levels. These conditions include certain types of arthritis; severe allergic reactions; multiple sclerosis (a disease in which the nerves do not function properly); lupus (a disease in which the body attacks many of its own organs); and certain conditions that affect the lungs, skin, eyes, kidneys...

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

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

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 Brown
ShapeRound
ImprintPI;1
Size7 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

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

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

  • UNII CQ3XH3DET6
    D&C Yellow No. 10 Aluminum Lake is a yellow colorant made by combining a dye with aluminum salts. It's used in medicines to add color for product identification and visual appeal.
  • UNII 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 7T9FYH5QMK
    A plant-derived powder that serves as a binder and filler in tablets and capsules. It helps hold ingredients together, adds bulk, and aids in smooth tablet disintegration when swallowed.
  • UNII H8AV0SQX4D
    A modified starch derived from potato or corn starch. It absorbs water quickly and helps tablets or capsules break apart and dissolve in the stomach, acting as a disintegrant to ensure the medicine releases its active ingredients properly.
  • 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.

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 DailyMedingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.041 $4.14 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.1189 $11.89 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.2837 $28.37 / 100 tablets
Medicare Part B allowsASP · J7512 $0.004 / J7512 unit
NADAC price history (per ea) — tap or hover for the price & month
Sep 2022 Jan 2024 Mar 2026 Aug 2026 $0.075 $0.040
▼ Down 40% over the last 15 months.
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)59651-484-01
11-digit billing NDC59651-0484-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7512
DescriptorPREDNISONE, IMMEDIATE RELEASE OR DELAYED RELEASE, ORAL, 1 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
PredniSONE 1 mg 00054-4741-25 Hikma 100 tablets $0.041 AB Availability likely
Prednisone 1 mg 00603-5335-21 Par 100 tablets $0.041 AB Availability likely
Prednisone 1 mgthis 59651-0484-01 Aurobindo 100 tablets $0.041 AB Availability likely
prednisone 1 mg 60219-1705-01 Amneal 100 tablets $0.041 AB Availability likely
Prednisone 1 mg 62135-0470-18 Chartwell 180 tablets $0.041 Availability likely
prednisone 1 mg 64380-0782-06 Strides 100 tablets $0.041 AB Availability likely
Prednisone 1 mg 70954-0056-10 ANI 100 tablets $0.041 AB Availability likely
PredniSONE 1 mg 00054-8739-25 Hikma 100 tablets $0.048 AB FDA listed +15%
prednisone 1 mg 00615-8438-39 NCS 30 tablets AB FDA listed
Prednisone 1 mg 63629-2254-01 Bryant 1000 tablets AB FDA listed
Prednisone 1 mg 68071-3958-09 NuCare 90 tablets AB FDA listed
Prednisone 1 mg 71205-0089-00 Proficient 100 tablets AB FDA listed
Prednisone 1 mg 71335-2273-01 Bryant 100 tablets AB FDA listed
Prednisone 1 mg 71335-3129-01 Bryant 100 tablets AB FDA listed
Prednisone 1 mg 72162-1169-00 Bryant 1000 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

🏛️
2021
On the market since
Nov 2021
📍
2026
Currently FDA-listed
5 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 59651-0484-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
9.2K
Units reimbursed last 4 qtrs
906.2K
Gross reimbursed last 4 qtrs
$107.8K
Avg / prescription
$11.66
Avg / unit
$0.1189
Latest quarter Q4 2025
2.1KRx
Medicaid pays / ea
$0.1189
gross reimbursed
vs
NADAC / ea
$0.0414
acquisition cost
=
Spread
+$0.0775
+187% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
43% FFS 57% MCO
Fee-for-service · 3,936 Rx Managed care · 5,308 Rx
State Medicaid map
Alaska: 6,687 units · 912 per 100k residents AK Maine: 6,063 units · 435 per 100k residents ME Washington: 73,963 units · 947 per 100k residents WA Idaho: 10,881 units · 554 per 100k residents ID Montana: 9,974 units · 881 per 100k residents MT North Dakota: no data reported ND Minnesota: 20,645 units · 360 per 100k residents MN Wisconsin: 21,430 units · 363 per 100k residents WI Michigan: 22,161 units · 221 per 100k residents MI New York: 87,928 units · 449 per 100k residents NY Vermont: 3,659 units · 566 per 100k residents VT New Hampshire: 8,861 units · 632 per 100k residents NH Oregon: 36,987 units · 874 per 100k residents OR Nevada: 1,612 units · 50.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 10,112 units · 315 per 100k residents IA Illinois: 22,255 units · 177 per 100k residents IL Indiana: 4,328 units · 63.1 per 100k residents IN Ohio: 20,704 units · 176 per 100k residents OH Pennsylvania: 40,134 units · 310 per 100k residents PA New Jersey: 21,280 units · 229 per 100k residents NJ Massachusetts: 22,127 units · 316 per 100k residents MA California: 210,920 units · 541 per 100k residents CA Utah: 3,152 units · 92.2 per 100k residents UT Colorado: 18,141 units · 309 per 100k residents CO Nebraska: 6,606 units · 334 per 100k residents NE Missouri: 7,572 units · 122 per 100k residents MO Kentucky: 9,028 units · 199 per 100k residents KY West Virginia: 2,962 units · 167 per 100k residents WV Virginia: 15,254 units · 175 per 100k residents VA Maryland: 16,322 units · 264 per 100k residents MD Connecticut: 17,889 units · 495 per 100k residents CT Rhode Island: no data reported RI Arizona: 11,799 units · 159 per 100k residents AZ New Mexico: 6,088 units · 288 per 100k residents NM Kansas: no data reported KS Arkansas: 1,926 units · 62.8 per 100k residents AR Tennessee: 7,510 units · 105 per 100k residents TN North Carolina: 14,179 units · 131 per 100k residents NC South Carolina: no data reported SC Delaware: 958 units · 92.9 per 100k residents DE Oklahoma: 3,910 units · 96.5 per 100k residents OK Louisiana: 8,516 units · 186 per 100k residents LA Mississippi: no data reported MS Alabama: 8,671 units · 170 per 100k residents AL Georgia: 2,829 units · 25.7 per 100k residents GA D.C.: 9,065 units · 1,335 per 100k residents DC Hawaii: no data reported HI Texas: 16,904 units · 55.4 per 100k residents TX Florida: 8,853 units · 39.2 per 100k residents FL
Units reimbursed · per 100k residents
25.71,335
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 1,335 /100k
2 Washington 947 /100k
3 Alaska 912 /100k
4 Montana 881 /100k
5 Oregon 874 /100k
6 New Hampshire 632 /100k
7 Vermont 566 /100k
8 Idaho 554 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
100 tablets this page59651-0484-01 9,244 Rx · $107,767
1000 tablets59651-0484-99 7,804 Rx · $86,891
10 tablets59651-0484-78 No Medicaid data
Drug total (last 4 qtrs): 17,048 Rx · 1,699,800 units · $194,658 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 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 Per unit Per pack Marketing startStatus
59651-0484-01 You're viewing this 100 TABLET in 1 BOTTLE (59651-484-01) $0.0414 / ea $4.14 2021-11-16 Active
59651-0484-78 10 BLISTER PACK in 1 CARTON (59651-484-78) / 10 TABLET in 1 BLISTER PACK 2021-11-16 Active
59651-0484-99 1000 TABLET in 1 BOTTLE (59651-484-99) $0.0414 / ea $41.37 2021-11-16 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.0414 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 54% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 59651-0484-01?
NDC 59651-0484-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 59651-0484-01 and NDC 59651-0484-78?
Both are PREDNISONE 1 mg Tablet — the drug itself is identical. NDC 59651-0484-01 is the 100-count package, while NDC 59651-0484-78 is the 100 tablets package.
What NDC number is used to bill for this package of PREDNISONE 1 mg Tablet?
Bill NDC 59651-0484-01 — the 11-digit billing format is 59651048401. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

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

INDICATIONS 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; posttraumatic osteoarthritis; synovitis of osteoarthritis; epicondylitis.

Collagen diseases : during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus, 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, serum sickness, bronchial asthma, contact dermatitis, atopic dermatitis, drug hypersensitivity reactions.

Ophthalmic diseases : severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa, such as: allergic conjunctivitis, keratitis, allergic corneal marginal ulcers, herpes zoster ophthalmicus, iritis and iridocyclitis, chorioretinitis, anterior segment inflammation, diffuse posterior uveitis and choroiditis, optic neuritis, sympathetic ophthalmia. 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. Miscellaneous: tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate anti-tuberculous chemotherapy, trichinosis with neurologic or myocardial involvement. In addition to the above indications, prednisone tablets are indicated for systemic dermatomyositis (polymyositis).

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION: Dosage of prednisone tablets should be individualized according to the severity of the disease and the response of the patient. For infants and children, the recommended dosage should be governed by the same considerations rather than strict adherence to the ratio indicated by age or body weight. Hormone therapy is an adjunct to, and not a replacement for, conventional therapy.

Dosage should be decreased or discontinued gradually when the drug has been administered for more than a few days. The severity, prognosis, expected duration of the disease, and the reaction of the patient to medication are primary factors in determining dosage. If a period of spontaneous remission occurs in a chronic condition, treatment should be discontinued.

Blood pressure, body weight, routine laboratory studies, including two-hour postprandial blood glucose and serum potassium, and a chest X-ray should be obtained at regular intervals during prolonged therapy. Upper GI X-rays are desirable in patients with known or suspected peptic ulcer disease The initial dosage of prednisone 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 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.

Contraindications 9 words

CONTRAINDICATIONS: Prednisone tablets are contraindicated in systemic fungal infections.

⚠️ Warnings ~2 min read

WARNINGS: In patients on corticosteroid therapy subject to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Immunosuppression and Increased Risk of Infection Corticosteroids, including prednisone, suppress the immune system and increase the risk of infection with any pathogen, including viral, bacterial, fungal, protozoan, or helminthic pathogens. Corticosteroids can: Reduce resistance to new infections Exacerbate existing infections Increase the risk of disseminated infections Increase the risk of reactivation or exacerbation of latent infections Mask some signs of infection Corticosteroid-associated infections can be mild but can be severe and at times fatal.

The rate of infectious complications increases with increasing corticosteroid dosages. Monitor for the development of infection and consider prednisone withdrawal or dosage reduction as needed. Tuberculosis If prednisone is used to treat a condition in patients with latent tuberculosis or tuberculin reactivity, reactivation of tuberculosis may occur.

Closely monitor such patients for reactivation. During prolonged prednisone therapy, patients with latent tuberculosis or tuberculin reactivity should receive chemoprophylaxis. Varicella Zoster and Measles Viral Infections Varicella and measles can have a serious or even fatal course in non-immune patients taking corticosteroids, including prednisone.

In corticosteroid-treated patients who have not had these diseases or are non-immune, particular care should be taken to avoid exposure to varicella and measles: If a prednisone-treated patient is exposed to varicella, prophylaxis with varicella zoster immune globulin may be indicated. If varicella develops, treatment with antiviral agents may be considered. If a prednisone-treated patient is exposed to measles, prophylaxis with immunoglobulin may be indicated.

Hepatitis B Virus Reactivation Hepatitis B virus reactivation can occur in patients who are hepatitis B carriers treated with immunosuppressive dosages of corticosteroids, including prednisone. Reactivation can also occur infrequently in corticosteroid-treated patients who appear to have resolved hepatitis B infection. Screen patients for hepatitis B infection before initiating immunosuppressive (e.g., prolonged) treatment with prednisone.

For patients who show evidence of hepatitis B infection, recommend consultation with physicians with expertise in managing hepatitis B regarding monitoring and consideration for hepatitis B antiviral therapy. Fungal Infections Corticosteroids, including prednisone, may exacerbate systemic fungal infections; therefore, avoid prednisone use in the presence of such infections unless prednisone is needed to control drug reactions. For patients on chronic prednisone therapy who develop systemic fungal infections, prednisone withdrawal or dosage reduction is recommended.

Amebiasis Corticosteroids, including prednisone, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating prednisone in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including prednisone, should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation.

In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including prednisone, in patients with cerebral malaria. Kaposi’s Sarcoma Kaposi’s sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for chronic conditions.

Discontinuation of corticosteroids may result in clinical improvement of Kaposi’s sarcoma. Prolonged use of corticosteroids…

🤒 Adverse Reactions 157 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. Neurological: convulsions, increased intracranial pressure with papilledema (pseudotumor cerebri) usually after treatment, vertigo, headache. Endocrine: menstrual irregularities ; development of cushingoid state; suppression of growth in children; secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness; decreased carbohydrate tolerance; manifestations of latent diabetes mellitus; increased requirements of insulin or oral hypoglycemic agents in diabetics.

Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos. Metabolic: negative nitrogen balance due to protein catabolism.

🧬 Clinical Pharmacology 62 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, such as prednisone, are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids, such as prednisone, cause profound and varied metabolic effects.

In addition, they modify the body's immune response to diverse stimuli.

📦 How Supplied / Storage and Handling 93 words

HOW SUPPLIED Prednisone Tablets USP, 1 mg are beige colored, round, biconvex tablets, scored on one side and “PI”, “1” on other side. They are supplied as follows: Bottles of 100 NDC 59651-484-01 Bottles of 1,000 NDC 59651-484-99 10x10 Unit-dose Tablets NDC 59651-484-78 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a tight, child-resistant container as defined in the USP/NF.

PROTECT FROM MOISTURE. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Revised: 02/2024

📋 Description 128 words

DESCRIPTION Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, that are readily absorbed from the gastrointestinal tract. The formula for prednisone is C 21 H 26 O 5 . Chemically, it is 17,21-dihydroxypregna-1,4-diene-3,11,20-trione and has the following structure.: Prednisone USP is a white to partially white, odorless, crystalline powder and has a molecular weight of 358.43.

It melts at about 230°C with some decomposition. Prednisone USP is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. Prednisone tablets USP contain 1 mg prednisone, USP.

The inactive ingredients for prednisone tablets USP include: D&C yellow No.10 aluminum lake, FD&C yellow # 6 aluminum lake, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch (maize), and sodium starch glycolate. Meets USP Dissolution Test 2. Chemical Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.