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PredniSONE 10 mg Tablet, 100-count — NDC 00054-0017-25 package photo

PredniSONE 10 mg Tablet, 100-count

by Hikma Pharmaceuticals USA Inc. · 100 TABLET in 1 BOTTLE, PLASTIC (0054-0017-25)
NDC 00054-0017-25
🏷️ FDA NDC (as labeled) 0054-0017-25 billing pads the labeler segment with a zero
This package
Contains100-count Cost per ea$0.0605 NADAC Per package$6.05 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.0500/unit · Part D plans $0.2837/unit — full pricing hub ↓
Also comes in: 100 tablets 00054-0017-20 500 tablets 00054-0017-29
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 0054-0017-25
Product NDC 0054-0017
11-digit billing NDC 00054001725
NCPDP billing unit EA — each (per item)
RxCUI 198144, 198145, 198146, 198148, 205301, 312615, 312617, 315187
UNII VB0R961HZT
UPC 0300543722507
Application # ANDA080352
SPL Set ID 3115aef0-fd50-4ec8-a064-3effb695f3f2
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 2003-02-13
Route ORAL
Dosage form TABLET
Substance PREDNISONE
GPI-14 22100045000320
GPI class predniSONE
GCN Seq No 006749
GCN 27172
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 10 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 0054-0017-25 — 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 → 00054-0017-25. 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

LabelerHikma Pharmaceuticals USA Inc.
Application holderHIKMA PHARMACEUTICALS USA INC
FDA applicationANDA080352 (ANDA)
Labeler code00054
First marketedFeb 2003
Product typeHuman Prescription Drug
Portfolio726 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 10 MG TABLET Ingredient Prednisone
📗 Our plain-language guide HelloPharmacist
  • Prednisone calms down your immune system and reduces inflammation in your body. It's used for a huge range of conditions — everything from asthma and severe allergies to Crohn's di...
  • Why did my doctor put me on prednisone — what does it actually do?
  • Yes, morning really does matter — your body naturally produces its own cortisol hormone between 2 a.m. and 8 a.m., and taking prednisone at that time works with your body's rhythm...
  • Do I really have to take it in the morning? And does it matter if I take it with food?
📖 Read our full Prednisone guide →
8
Nutrient depletion considerations

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

🧪 Full Prednisone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
Imprint54;612
Size6 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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

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 $0.061 $6.05 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.0500 $5.00 / 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
Dec 2021 Mar 2022 Oct 2022 Feb 2024 $0.075 $0.058
▼ Down 19% over the last 12 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)0054-0017-25
11-digit billing NDC00054-0017-25
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 / pkg10 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 10 mg 00054-9817-25 Hikma 100 tablets $0.053 AB Availability likely save 12%
Prednisone 10 mg 00378-0641-01 Mylan 100 tablets $0.053 — Availability likely save 12%
Prednisone 10 mg 00591-5442-01 Actavis 100 tablets $0.053 — Availability likely save 12%
Prednisone 10 mg 00904-6923-61 Major 100 tablets $0.053 AB Availability likely save 12%
Prednisone 10 mg 59651-0487-01 Aurobindo 100 tablets $0.053 AB Availability likely save 12%
prednisone 10 mg 60219-1707-01 Amneal 100 tablets $0.053 AB Availability likely save 12%
Prednisone 10 mg 60687-0134-01 American 100 tablets $0.053 AB Availability likely save 12%
Prednisone 10 mg 60687-0914-01 American 100 tablets $0.053 AB Availability likely save 12%
PredniSONE Tablets, USP, 10 mg 63561-0121-01 Granulation 100 tablets $0.053 AB Availability likely save 12%
Prednisone 10 mg 70954-0059-10 ANI 100 tablets $0.053 AB Availability likely save 12%
PredniSONE 10 mgthis 00054-0017-25 Hikma 100 tablets $0.060 AB FDA listed —
Prednisone 10 mg 00603-5338-15 Par 21 tablets $0.585 AB Availability likely +867%
prednisone 10 mg 00615-8440-05 NCS 15 tablets — AB FDA listed —
Prednisone 10 mg 10135-0777-01 Marlex 100 tablets — AB FDA listed —
PredniSONE 10 mg 42708-0045-21 QPharma, 21 tablets — — FDA listed —
Prednisone 10 mg 42708-0115-21 QPharma, 21 tablets — AB FDA listed —
prednisone 10 mg 42708-0166-21 QPharma 21 tablets — AB FDA listed —
Prednisone 10 mg 50090-3137-00 A-S 10 tablets — AB FDA listed —
Prednisone 10 mg 50090-5202-00 A-S 60 tablets — AB FDA listed —
Prednisone 10 mg 50090-7023-00 A-S 100 tablets — AB FDA listed —
Prednisone 10 mg 50090-7024-00 A-S 10 tablets — AB FDA listed —
Prednisone 10 mg 50090-7025-00 A-S 60 tablets — AB FDA listed —
prednisone 10 mg 50090-7218-00 A-S 10 tablets — AB FDA listed —
prednisone 10 mg 50090-7219-00 A-S 60 tablets — AB FDA listed —
prednisone 10 mg 50090-7369-00 A-S 10 tablets — AB FDA listed —
prednisone 10 mg 50090-7371-00 A-S 60 tablets — AB FDA listed —
Prednisone 10 mg 51407-0922-10 Golden 1000 tablets — — FDA listed —
Prednisone 10 mg 51655-0410-20 Northwind 20 tablets — AB FDA listed —
PredniSONE 10 mg 51655-0493-49 Northwind 42 tablets — — FDA listed —
Prednisone 10 mg 51655-0935-20 Northwind 20 tablets — — FDA listed —
Prednisone 10 mg 54348-0506-10 PharmPak, 10 tablets — AB FDA listed —
Prednisone 10 mg 55154-3564-00 Cardinal 10 tablets — AB FDA listed —
Prednisone 10 mg 63187-0037-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 63187-0300-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 63629-2257-01 Bryant 1000 tablets — AB FDA listed —
prednisone 10 mg 64380-0784-01 Strides 100 tablets — AB FDA listed —
Prednisone 10 mg 66267-0171-15 NuCare 15 tablets — AB FDA listed —
Prednisone 10 mg 66267-0812-10 NuCare 100 tablets — AB FDA listed —
prednisone 10 mg 67046-1579-03 Coupler 30 tablets — AB FDA listed —
Prednisone 10 mg 67296-0140-01 Redpharm 10 tablets — AB Discontinued —
Prednisone 10 mg 68071-2661-00 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3641-01 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3746-00 NuCare 10 tablets — AB FDA listed —
Prednisone 10 mg 68071-3821-03 NuCare 30 tablets — AB FDA listed —
prednisone 10 mg 68788-8166-02 Preferred 21 tablets — AB FDA listed —
prednisone 10 mg 70518-3476-00 REMEDYREPACK 21 tablets — AB Discontinued —
prednisone 10 mg 70518-4038-00 REMEDYREPACK 48 tablets — AB FDA listed —
PredniSONE 10 mg 70518-4191-01 REMEDYREPACK 30 tablets — — FDA listed —
prednisone 10 mg 70518-4354-00 REMEDYREPACK 30 tablets — AB FDA listed —
Prednisone 10 mg 70518-4560-00 REMEDYREPACK 18 tablets — AB FDA listed —
prednisone 10 mg 70518-4660-00 REMEDYREPACK 14 tablets — AB FDA listed —
Prednisone 10 mg 71205-0362-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 71205-0421-10 Proficient 10 tablets — AB FDA listed —
prednisone 10 mg 71205-0729-10 Proficient 10 tablets — AB FDA listed —
prednisone 10 mg 71205-0818-05 Proficient 5 tablets — AB FDA listed —
Prednisone 10 mg 71335-0335-00 Bryant 10 tablets — AB Discontinued —
prednisone 10 mg 71335-2069-00 Bryant 10 tablets — AB FDA listed —
prednisone 10 mg 71335-2122-01 Bryant 5 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-2736-00 Bryant 12 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-2752-00 Bryant 10 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-3044-01 Bryant 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 71335-3045-01 Bryant 1000 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72162-2485-00 Bryant 1000 tablets — AB FDA listed —
Prednisone 10 mg 72189-0589-10 Direct_Rx 10 tablets — AB FDA listed —
Prednisone 10 mg 72789-0401-10 PD-Rx 10 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72789-0475-01 PD-Rx 100 tablets — AB FDA listed —
PredniSONE Tablets, USP, 10 mg 72789-0513-10 PD-Rx 10 tablets — AB FDA listed —
Prednisone 10 mg 76420-0068-20 Asclemed 20 tablets — AB FDA listed —
prednisone 10 mg 76420-0412-00 Asclemed 1000 tablets — AB FDA listed —
Prednisone 10 mg 80425-0193-01 Advanced 21 tablets — AB FDA listed —
prednisone 10 mg 80425-0484-01 Advanced 21 tablets — AB FDA listed —
PredniSONE 10 mg 80425-0485-01 Advanced 21 tablets — — FDA listed —
Prednisone 10 mg 80425-0491-01 Advanced 21 tablets — AB FDA listed —
prednisone 10 mg 85766-0001-00 Sportpharm 1000 tablets — AB FDA listed —
Prednisone 10 mg 87063-0044-01 ASCLEMED 100 tablets — AB FDA listed —
Prednisone 10 mg 50090-1001-00 A-S 21 tablets — AB FDA listed —
Prednisone 10 mg 50090-1002-00 A-S 48 tablets — AB Discontinued —
PredniSONE 10 mg 55289-0330-05 PD-Rx 5 tablets — — FDA listed —
prednisone 10 mg 51655-0972-20 Northwind 20 tablets — AB FDA listed —
PredniSONE 10 mg 51655-0726-21 Northwind 21 tablets — AB FDA listed —
prednisone 10 mg 87441-0069-01 Unit 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2003
On the market since
Feb 2003
📍
2026
Currently FDA-listed
23 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 00054-0017-25, 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
11
Units reimbursed last 4 qtrs
1
Gross reimbursed last 4 qtrs
$0.05
Avg / unit
$0.0455
Latest quarter Q4 2025
0Rx
Medicaid pays / ea
$0.0455
gross reimbursed
vs
NADAC / ea
$0.0605
acquisition cost
=
Spread
−$0.0150
-25% 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 ⓘ
100% MCO
Fee-for-service · 0 Rx Managed care · 11 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: no data reported WI Michigan: no data reported MI New York: 1 units · 0.0 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported 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: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: no data reported VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: no data reported TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported 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: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
0.00.0
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 York 0.0 /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.
10 tablets00054-0017-20 409 Rx · $1,844
500 tablets00054-0017-29 265 Rx · $1,217
100 tablets this page00054-0017-25 11 Rx · $0
Drug total (last 4 qtrs): 685 Rx · 11,589 units · $3,061 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
00054-0017-20 10 BLISTER PACK in 1 CARTON (0054-0017-20) / 10 TABLET in 1 BLISTER PACK $0.0605 / ea $6.05 2003-02-13 Active
00054-0017-25 You're viewing this 100 TABLET in 1 BOTTLE, PLASTIC (0054-0017-25) $0.0605 / ea $6.05 2003-02-13 Active
00054-0017-29 500 TABLET in 1 BOTTLE, PLASTIC (0054-0017-29) $0.0693 / ea $34.63 2003-02-13 Active

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0605 NADAC).

This pack accounts for about 1.6% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓

Pack size FAQ

What quantity is in NDC 00054-0017-25?
NDC 00054-0017-25 is a 100-count package — 100 tablet in 1 bottle, plastic.
What is the difference between NDC 00054-0017-25 and NDC 00054-0017-20?
Both are PredniSONE 10 mg Tablet — the drug itself is identical. NDC 00054-0017-25 is the 100-count package, while NDC 00054-0017-20 is the 100 tablets package.
What NDC number is used to bill for this package of PredniSONE 10 mg Tablet?
Bill NDC 00054-0017-25 — the 11-digit billing format is 00054001725. 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 ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 📦 How Supplied / Storage and Handling 📋 Description
🎯 Indications and Usage ~2 min read ▾

INDICATIONS Prednisone tablets and solutions are indicated in the following conditions: 1. Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance) Congenital adrenal hyperplasia Hypercalcemia associated with cancer Nonsuppurative thyroiditis 2. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Acute nonspecific tenosynovitis Acute gouty arthritis Post-traumatic osteoarthritis Synovitis of osteoarthritis Epicondylitis 3.

Collagen Diseases During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis 4. Dermatologic Diseases Pemphigus Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Exfoliative dermatitis Mycosis fungoides Severe psoriasis Severe seborrheic dermatitis 5. Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Bronchial asthma Contact dermatitis Atopic dermatitis Serum sickness Drug hypersensitivity reactions 6.

Ophthalmic Diseases Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: Allergic corneal marginal ulcers Herpes zoster ophthalmicus Anterior segment inflammation Diffuse posterior uveitis and choroiditis Sympathetic ophthalmia Allergic conjunctivitis Keratitis Chorioretinitis Optic neuritis Iritis and iridocyclitis 7. Respiratory Diseases Symptomatic sarcoidosis Loeffler’s syndrome not manageable by other means Berylliosis Fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy Aspiration pneumonitis 8.

Hematologic Disorders Idiopathic thrombocytopenic purpura in adults Secondary thrombocytopenia in adults Acquired (autoimmune) hemolytic anemia Erythroblastopenia (RBC anemia) Congenital (erythroid) hypoplastic anemia 9. Neoplastic Diseases For palliative management of: Leukemias and lymphomas in adults Acute leukemia of childhood 10. Edematous States To induce a diuresis or remission of proteinuria in the nephrotic syndrome, without uremia, of the idiopathic type or that due to lupus erythematosus.

11. Gastrointestinal Diseases To tide the patient over a critical period of the disease in: Ulcerative colitis Regional enteritis 12. Nervous System Acute exacerbations of multiple sclerosis 13.

Miscellaneous Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy Trichinosis with neurologic or myocardial involvement

⏱️ Dosage and Administration ~3 min read ▾

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

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

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

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

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

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

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

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

⛔ Contraindications 9 words ▾

CONTRAINDICATIONS Systemic fungal infections and known hypersensitivity to components.

⚠️ Warnings ~2 min read ▾

WARNINGS In patients on corticosteroid therapy subjected to unusual stress, increased dosage of rapidly acting corticosteroids before, during, and after the stressful situation is indicated. 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.

Usage in pregnancy Si…

🤒 Adverse Reactions 173 words ▾

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

📦 How Supplied / Storage and Handling ~2 min read ▾

HOW SUPPLIED PredniSONE Tablets, USP 1 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 092” debossed on the other side. NDC 0054-8739-25: 10x10 Unit-Dose NDC 0054-4741-25: Bottle of 100 Tablets NDC 0054-4741-31: Bottle of 1,000 Tablets 2.5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 339” debossed on the other side. NDC 0054-8740-25: 10x10 Unit-Dose NDC 0054-4742-25: Bottle of 100 Tablets 5 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 612” debossed on the other side.

NDC 0054-8724-25: 10x10 Unit-Dose NDC 0054-4728-25: Bottle of 100 Tablets NDC 0054-4728-31: Bottle of 1,000 Tablets 10 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 899” debossed on the other side. NDC 0054-0017-20: 10x10 Unit-Dose NDC 0054-0017-25: Bottle of 100 Tablets NDC 0054-0017-29: Bottle of 500 Tablets 20 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 760” debossed on the other side. NDC 0054-0018-20: 10x10 Unit-Dose NDC 0054-0018-25: Bottle of 100 Tablets NDC 0054-0018-29: Bottle of 500 Tablets 50 mg – White to off-white, round, biconvex tablet; scored on one side and product identification “54 [above] 343” debossed on the other side.

NDC 0054-0019-20: 10x10 Unit-Dose NDC 0054-0019-25: Bottle of 100 Tablets 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. PredniSONE Oral Solution USP, 5 mg per 5 mL Clear, colorless, slightly viscous solution.

NDC 0054-3722-50: Bottle of 120 mL NDC 0054-3722-63: Bottle of 500 mL Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant, child-resistant container as defined in the USP/NF. PredniSONE Intensol™ Oral Solution (Concentrate), 5 mg per mL Clear, colorless, slightly viscous solution. NDC 0054-3721-44: Bottle of 30 mL with calibrated oral syringe (graduations of 0.25 mL [1.25 mg] to 1 mL [5 mg] on the syringe) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense only in the bottle and only with the calibrated oral syringe provided.

Discard opened bottle after 90 days. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000278/04 -k02 Revised February 2024

📋 Description 200 words ▾

DESCRIPTION Prednisone is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Prednisone, USP is a white to partially white, crystalline powder.

It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. The chemical name for prednisone is 17,21-dihydroxypregna-1,4-dienne-3,11,20-trione. The structural formula is represented below: C 21 H 26 O 5 M.W.

358.44 Each tablet, for oral administration, contains 1, 2.5, 5, 10, 20, or 50 mg of prednisone. PredniSONE Oral Solution contains 5 mg prednisone per 5 mL, and PredniSONE Intensol TM Oral Solution (Concentrate) contains 5 mg prednisone per mL. Inactive Ingredients: PredniSONE Tablets, USP contain the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate and stearic acid (1 mg, 2.5 mg, and 5 mg only).

PredniSONE Oral Solution, USP contains alcohol 5% and the following inactive ingredients: anhydrous citric acid, edetate disodium, fructose, hydrochloric acid, maltol, peppermint oil, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate, vanilla flavor and purified water. PredniSONE Intensol™ Oral Solution (Concentrate) contains alcohol 30% and the following inactive ingredients: anhydrous citric acid, poloxamer 188, propylene glycol and purified water. Chemical Structure

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