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Prednisone 20 mg Tablet, 100-count — NDC 00378-0642-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Prednisone 20 mg Tablet, 100-count — NDC 0378-0642-01 (Billing 00378-0642-01)

by Mylan Pharmaceuticals Inc. · 100 TABLET in 1 BOTTLE, PLASTIC

This is a package of 100 tablets of Prednisone 20 mg Tablet from Mylan Pharmaceuticals Inc., marketed since Feb 2020 and currently FDA-listed; retail pharmacies pay about $0.0643 per tablet (NADAC).

NDC 00378-0642-01
🏷️ FDA NDC (as labeled) 0378-0642-01 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0643 NADAC Per package$6.43 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $4.33/unit · Part D plans $0.2837/unit — full pricing hub ↓
Product page 00378-0642-10 Also comes in: 500 tablets 0378-0642-05 1000 tablets 0378-0642-10
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0378-0642-01
Product NDC 0378-0642
11-digit billing NDC 00378064201
NCPDP billing unit EA — each (per item)
RxCUI 198145, 312615, 312617
UNII VB0R961HZT
UPC 0303780641013, 0303780640016, 0303780642010
Application # ANDA083677
SPL Set ID fec09050-5ac2-451b-a2b9-5a21b2def212
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 2020-02-06
Route ORAL
Dosage form TABLET
Substance PREDNISONE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 22100045000325
GPI class predniSONE
GCN Seq No 006751
GCN 27174
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 20 MG TABLET
FDB brand name Prednisone
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 006751
  • GCN: 27174
  • GPI-14 (Medi-Span): 22100045000325
  • HICL (First Databank): 002879
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 198145
Why two NDCs? The FDA registers this code as 0378-0642-01 — a 4-4-2 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 labeler segment → 00378-0642-01. 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.

Clinical

Label name PREDNISONE 20 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
  • It calms inflammation and lowers immune activity. It is used for allergies, arthritis, lupus, skin, gut, lung, eye and blood conditions, and more. Your prescriber chose it for your...
  • Take it with food or milk to protect your stomach. A once-daily dose is usually best in the morning. If you have delayed-release tablets, take them with food and swallow them whole...
  • No, not after long-term use. Your body may need time to restart its own steroid production. Your doctor will lower the dose gradually.
  • Bigger appetite, weight gain, trouble sleeping, mood swings and stomach upset are common. Call your doctor for signs of infection, black stools, severe stomach pain, vision changes...
📖 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.

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 $0.064 $6.43 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $4.33 $432.79 / 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
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.117 $0.064
▼ Down 43% over the last 24 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)0378-0642-01
11-digit billing NDC00378-0642-01
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ7512
DescriptorPREDNISONE, IMMEDIATE RELEASE OR DELAYED RELEASE, ORAL, 1 MG
Billing units / pkg20 units
How the units are derivedThis package is 100 EA; the HCPCS unit is 1 MG, so one package = 20 billing units.
Medicare Part B spend (2026 (Q1))$63,912 · 65,179 claims · $0.98 per claim (all NDCs under J7512)
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.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00378-0642-01 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC $0.0643 / ea $6.43 2020-02-11 — Active
00378-0642-05 0378-0642-05 500 TABLET in 1 BOTTLE, PLASTIC $0.0643 / ea $32.16 2020-02-06 — Active
00378-0642-10 0378-0642-10 Main listing 1000 TABLET in 1 BOTTLE, PLASTIC $0.0643 / ea $64.31 2020-02-11 — Active

You're viewing the smallest of 3 pack sizes for this product.

This pack has the lowest per-ea cost of the 3 priced pack sizes ($0.0643 NADAC).

This pack accounts for about 12% of this product's recent Medicaid fills; most go to the 1000 tablets pack. See all packs ↓

Pack size FAQ

What quantity is in this package?
This is a 100-count package — 100 tablet in 1 bottle, plastic.
How does this package differ from NDC 00378-0642-05?
Both are Prednisone 20 mg Tablet — the drug itself is identical. This page's package is the 100-count one, while NDC 00378-0642-05 is the 500 tablets package.
What NDC number is used to bill for this package of Prednisone 20 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Prednisone 20 mgthis 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 +43%
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 mg 76420-0069-10 Asclemed 10 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 —
prednisone 20 mg 50090-8051-01 A-S 10 tablets — AB FDA listed —
Prednisone 20 mg 50090-8083-00 A-S 8 tablets — AB FDA listed —
Prednisone 20 mg 50090-8087-00 A-S 21 tablets — AB FDA listed —
Prednisone 20 mg 50090-8084-00 A-S 20 tablets — AB FDA listed —
prednisone 20 mg 50090-8052-00 A-S 20 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

🏛️
2020
On the market since
Feb 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color White / Orange
ShapeRound
ImprintM;PS;20
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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • 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 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 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.

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.

Manufacturer & labeler

LabelerMylan Pharmaceuticals Inc.
Application holderMYLAN PHARMACEUTICALS INC
FDA applicationANDA083677 (ANDA)
Labeler code00378
First marketedFeb 2020
Product typeHuman Prescription Drug
Portfolio473 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients ⚠️ Precautions 🍼 Nursing Mothers 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 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. Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy; trichinosis with neurologic or myocardial involvement.

⏱️ Dosage and Administration ~3 min read ▾

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

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

Do not stop taking this medicine without first talking to your doctor. Avoid abrupt withdraw of therapy. The initial dosage of prednisone may vary from 5 mg to 60 mg per day, depending on the specific disease entity being treated.

In situations of less severity lower doses will generally suffice, while in selected patients higher initial doses may be required. The initial dosage should be maintained or adjusted until a satisfactory response is noted. If after a reasonable period of time there is a lack of satisfactory clinical response, prednisone should be discontinued and the patient transferred to other appropriate therapy.

IT SHOULD BE EMPHASIZED THAT DOSAGE REQUIREMENTS ARE VARIABLE AND MUST BE INDIVIDUALIZED ON THE BASIS OF THE DISEASE UNDER TREATMENT AND THE RESPONSE OF THE PATIENT. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small increments at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. It should be kept in mind that constant monitoring is needed in regard to drug dosage.

Included in the situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment; in this latter situation, it may be necessary to increase the dosage of prednisone for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

Multiple Sclerosis In the treatment of acute exacerbations of multiple sclerosis daily doses of 200 mg of prednisolone for a week followed by 80 mg every other day for 1 month have been shown to be effective. (Dosage range is the same for prednisone and prednisolone.) Alternate Day Therapy Alternate day therapy is a corticosteroid dosing regimen in which twice the usual daily dose of corticoid is administered every other morning. The purpose of this mode of therapy is to provide the patient requiring long-term pharmacologic dose treatment with the beneficial effects of corticoids while minimizing certain undesirable effects, including pituitary-adrenal suppression, the cushingoid state, corticoid withdrawal symptoms, and growth suppression in children.

The rationale for this treatment schedule is based on two major premises: (a) the anti-inflammatory or therapeutic effect of corticoids persists longer than their physical presence and metabolic effects and (b) administration of the corticosteroid every other morning allows for re-establishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the off-steroid day. A brief review of the HPA physiology may be helpful in understanding this rationale. Acting primarily through the hypothalamus a fall in free cortisol stimulates the pituitary gland to produce increasing amounts of corticotropin (ACTH) while a rise in free cortisol inhibits ACTH secretion.

Normally the HPA system is characterized by diurnal (circadia… [Excerpted — this section continues on DailyMed.]

⛔ Contraindications 14 words ▾

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

⚠️ Warnings ~2 min read ▾

WARNINGS General Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS: Allergic Reactions ). Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during and after the stressful situation. Immunosuppression and Increased Risk of Infection Corticosteroids, including prednisone tablets, 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 tablets withdrawal or dosage reduction as needed.

Do not administer prednisone tablets by an intraarticular, intrabursal, intratendinous, or intralesional route in the presence of acute local infection. Tuberculosis If prednisone tablets are 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 tablets 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 tablets. 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 tablets-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 tablets-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 tablets. 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 tablets. 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 tablets, may exacerbate systemic fungal infections; therefore, avoid prednisone tablets use in the presence of such infections unless prednisone tablets are needed to control drug reactions.

For patients on chronic prednisone tablets therapy who develop systemic fungal infections, prednisone tablets withdrawal or dosage reduction is recommended. Amebiasis Corticosteroids, including prednisone tablets, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating prednisone tablets in patients who have spent time in the tropics or patients with unexplained diarrhea.

Strongyloides Infestation Corticosteroids, including prednisone tablets, 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 migr… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~2 min read ▾

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

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

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

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

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

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

🔄 Drug Interactions 55 words ▾

Drug Interactions Amphotericin B Injection and Potassium-Depleting Agents When corticosteroids are administered concomitantly with potassium-depleting agents (e.g., amphotericin B, diuretics ), patients should be observed closely for development of hypokalemia. In addition, there have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure.

🤰 Pregnancy 96 words ▾

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

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

🧒 Pediatric Use ~1 min read ▾

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

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

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

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

🧓 Geriatric Use 101 words ▾

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

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

🧬 Clinical Pharmacology 57 words ▾

CLINICAL PHARMACOLOGY Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body’s immune responses to diverse stimuli.

📦 How Supplied / Storage and Handling 204 words ▾

HOW SUPPLIED Prednisone Tablets, USP are available containing 5 mg, 10 mg or 20 mg of prednisone, USP. The 5 mg tablets are white, round, scored tablets debossed with M on one side of the tablet and PS above the score and 5 below the score on the other side. They are available as follows: NDC 0378-0640-01 bottles of 100 tablets NDC 0378-0640-10 bottles of 1000 tablets The 10 mg tablets are white, round, scored tablets debossed with M on one side of the tablet and PS above the score and 10 below the score on the other side.

They are available as follows: NDC 0378-0641-01 bottles of 100 tablets NDC 0378-0641-10 bottles of 1000 tablets The 20 mg tablets are peach, round, scored tablets debossed with M on one side of the tablet and PS above the score and 20 below the score on the other side. They are available as follows: NDC 0378-0642-01 bottles of 100 tablets NDC 0378-0642-05 bottles of 500 tablets NDC 0378-0642-10 bottles of 1000 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

📋 Description 146 words ▾

DESCRIPTION Each tablet for oral administration contains: Prednisone, USP.................................................5 mg, 10 mg and 20 mg Inactive Ingredients Prednisone tablets, USP of 5 mg and 10 mg strengths contain anhydrous lactose, colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, and talc. Prednisone tablets of 20 mg strength contain anhydrous lactose, D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No.

6 Aluminum Lake, magnesium stearate, microcrystalline cellulose and sodium starch glycolate. 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: C 21 H 26 O 5 M.W. 358.43 Prednisone, USP is a white to practically white, odorless, crystalline powder.

It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. structural formula

💬 Information for Patients 116 words ▾

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

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

⚠️ Precautions ~3 min read ▾

PRECAUTIONS General Precautions The lowest possible dose of corticosteroids should be used to control the condition under treatment. When reduction in dosage is possible, the reduction should be gradual. Since complications of treatment with glucocorticoids are dependent on the size of the dose and the duration of treatment, a risk/benefit decision must be made in each individual case as to dose and duration of treatment and as to whether daily or intermittent therapy should be used.

Cardio-Renal As sodium retention with resultant edema and potassium loss may occur in patients receiving corticosteroids, these agents should be used with caution in patients with congestive heart failure, hypertension, or renal insufficiency. Endocrine Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for up to 12 months after discontinuation of therapy following large doses for prolonged periods; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

Since mineralocorticoid secretion may be impaired, salt and/or a mineralocorticoid should be administered concurrently. There is an enhanced effect of corticosteroids on patients with hypothyroidism. Gastrointestinal Steroids should be used with caution in active or latent peptic ulcers, diverticulitis, fresh intestinal anastomoses, and nonspecific ulcerative colitis, since they may increase the risk of a perforation.

Signs of peritoneal irritation following gastrointestinal perforation in patients receiving corticosteroids may be minimal or absent. There is an enhanced effect due to decreased metabolism of corticosteroids in patients with cirrhosis. Musculoskeletal Corticosteroids decrease bone formation and increase bone resorption both through their effect on calcium regulation (i.e., decreasing absorption and increasing excretion) and inhibition of osteoblast function.

This, together with a decrease in the protein matrix of the bone secondary to an increase in protein catabolism, and reduced sex hormone production, may lead to inhibition of bone growth in pediatric patients and the development of osteoporosis at any age. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. Special consideration should be given to patients at increased risk of osteoporosis (e.g., postmenopausal women) before initiating corticosteroid therapy.

Inclusion of therapy for osteoporosis prevention or treatment should be considered. To minimize the risk of glucocorticoid-induced bone loss, the smallest possible effective dosage and duration should be used. Lifestyle modification to reduce the risk of osteoporosis (e.g., cigarette smoking cessation, limitation of alcohol consumption, participation in weight-bearing exercise for 30-60 minutes daily) should be encouraged.

Calcium and vitamin D supplementation, bisphosphonate (e.g., alendronate, risedronate), and a weight-bearing exercise program that maintains muscle mass are suitable first-line therapies aimed at reducing the risk of adverse bone effects. Current recommendations suggest that all interventions be initiated in any patient in whom glucocorticoid therapy with at least the equivalent of 5 mg of prednisone for at least 3 months is anticipated; in addition, sex hormone replacement therapy (combined estrogen and progestin in women; testosterone in men) should be offered to such patients who are hypogonadal or in whom replacement is otherwise clinically indicated and biphosphonate therapy should be initiated (if not already) if bone mineral density (BMD) of the lumbar spine and/or hip is below normal.

Neuro-Psychiatric Although controlled clinical trials have shown corticosteroids to be effective in speeding the resolution of acute exacerbations of multiple sclerosis, they do not show that they affect the ultimate outcome or natural history of the disease.… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 61 words ▾

Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from corticosteroids, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 37 words ▾

Carcinogenesis, Mutagenesis, Impairment of Fertility No adequate studies have been conducted in animals to determine whether corticosteroids have a potential for carcinogenesis or mutagenesis. Steroids may increase or decrease motility and number of spermatozoa in some patients.

📚 References 71 words ▾

REFERENCES 1. Fekety R. Infections associated with corticosteroids and immunosuppressive therapy.

In: Gorbach SL, Bartlett JG, Blacklow NR, eds. Infectious Diseases . Philadelphia: WBSaunders Company 1992:1050-1.

2. Stuck AE, Minder CE, Frey FJ. Risk of infectious complications in patients taking glucocorticoids.

Rev Infect Dis 1989:11(6):954-63. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Manufactured by: ALPHAPHARM PTY LTD 15 Garnet Street Carole Park QLD 4300 Australia Revised: 6/2024 ALP:PREDT:R3 (3506/2)

📄 Package Label / Principal Display Panel ~1 min read ▾

PRINCIPAL DISPLAY PANEL – 5 mg NDC 0378-0640-01 predniSONE Tablets, USP 5 mg Rx only 100 Tablets Each tablet contains: Prednisone, USP 5 mg Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Keep this and all medication out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Usual Dosage: See accompanying prescribing information. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Made in Australia Mylan.com 3490/0 RALP0640A Prednisone Tablets, USP 5 mg Bottle Label

PRINCIPAL DISPLAY PANEL – 10 mg NDC 0378-0641-01 predniSONE Tablets, USP 10 mg Rx only 100 Tablets Each tablet contains: Prednisone, USP 10 mg Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Keep this and all medication out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Usual Dosage: See accompanying prescribing information. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Made in Australia Mylan.com 3501/0 RALP0641A Prednisone Tablets, USP 10 mg Bottle Label

PRINCIPAL DISPLAY PANEL – 20 mg NDC 0378-0642-01 predniSONE Tablets, USP 20 mg Rx only 100 Tablets Each tablet contains: Prednisone, USP 20 mg Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed. Keep this and all medication out of the reach of children.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from light and moisture. Usual Dosage: See accompanying prescribing information. Manufactured for: Mylan Pharmaceuticals Inc.

Morgantown, WV 26505 U.S.A. Made in Australia Mylan.com 3503/0 RALP0642A Prednisone Tablets, USP 20 mg Bottle Label

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

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 this package alone, 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 – Q1 2026 · 5 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
886
Units reimbursed last 4 qtrs
9.9K
Gross reimbursed last 4 qtrs
$43K
Avg / prescription
$48.50
Avg / unit
$4.3281
Latest quarter Q1 2026
398Rx
Medicaid pays / ea
$4.3281
gross reimbursed
vs
NADAC / ea
$0.0643
acquisition cost
=
Spread
+$4.2638
+6631% 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 ⓘ
76% FFS 24% MCO
Fee-for-service · 675 Rx Managed care · 211 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 1,280 units · 21.7 per 100k residents WI Michigan: no data reported MI New York: 3,503 units · 17.9 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: 221 units · 5.2 per 100k residents OR Nevada: 197 units · 6.2 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: 164 units · 1.4 per 100k residents OH Pennsylvania: no data reported PA New Jersey: 89 units · 1.0 per 100k residents NJ Massachusetts: no data reported MA California: 1,483 units · 3.8 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 1,102 units · 17.8 per 100k residents MO Kentucky: 182 units · 4.0 per 100k residents KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: 137 units · 2.2 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 1,085 units · 51.3 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: 192 units · 1.8 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 134 units · 2.9 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 160 units · 0.5 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.551.3
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 New Mexico 51.3 /100k
2 Wisconsin 21.7 /100k
3 New York 17.9 /100k
4 Missouri 17.8 /100k
5 Nevada 6.2 /100k
6 Oregon 5.2 /100k
7 Kentucky 4.0 /100k
8 California 3.8 /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.
1000 tablets00378-0642-10 4,049 Rx · $112,807
500 tablets00378-0642-05 2,253 Rx · $89,416
100 tablets this page00378-0642-01 886 Rx · $42,972
Drug total (last 4 qtrs): 7,188 Rx · 81,568 units · $245,195 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.
← 00378-0641-01 · Mylan 00378-0757-01 · Mylan →
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.