HomeNDC LookupIngredientsMethylprednisolone › 68382-0916-01
methylprednisolone 4 mg Tablet, 100-count — NDC 68382-0916-01 package photo

methylprednisolone 4 mg Tablet, 100-count

by Zydus Pharmaceuticals USA Inc. · 100 TABLET in 1 BOTTLE (68382-916-01)
NDC 68382-0916-01
🏷️ FDA NDC (as labeled) 68382-916-01 billing pads the product segment with a zero
This package
Contains100-count Cost per ea$0.1240 NADAC Per package$12.40 / 100 tablets Pack sizes3 compare ↓
Also priced by: Medicaid pays $0.3929/unit · Part D plans $0.3466/unit — full pricing hub ↓
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Methylprednisolone (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jan 15, 2026 — Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil. (Greenstone Llc) · FDA recall D-0299-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 68382-916-01
Product NDC 68382-916
11-digit billing NDC 68382091601
NCPDP billing unit EA — each (per item)
UNII X4W7ZR7023
Application # ANDA206751
SPL Set ID eaa9c932-c659-4ef6-bf5a-186545d87320
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 2018-05-01
Route ORAL
Dosage form TABLET
Substance METHYLPREDNISOLONE
GPI-14 22100030000310
GPI class methylPREDNISolone
GCN Seq No 006741
GCN 27056
HICL code 002877
Ingredient (HICL) Methylprednisolone
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 METHYLPREDNISOLONE 4 MG TABLET
FDB brand name Methylprednisolone
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 68382-916-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 68382-0916-01. 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, potent (group III), Corticosteroids, weak (group I), 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

LabelerZydus Pharmaceuticals USA Inc.
Application holderZYDUS PHARMACEUTICALS USA INC
FDA applicationANDA206751 (ANDA)
Labeler code68382
First marketedMay 2018
Product typeHuman Prescription Drug
Portfolio451 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 METHYLPREDNISOLONE 4 MG TABLET Ingredient Methylprednisolone
📖 What it is MedlinePlus · NLM

Methylprednisolone, a corticosteroid, is similar to a natural hormone produced by your adrenal glands. It is often used to replace this chemical when your body does not make enough of it. It relieves inflammation (swelling, heat, redness, and pain) and is used to treat certain forms of arthritis; skin, blood, kidney, eye, thyroid, and intestinal disorders (e.g., colitis); severe allergies; and asthma. Methylprednisolone is also used to treat certain types of cancer. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Methylprednisolone is used for a very wide range of conditions — basically anything where your immune system or inflammation is causing the problem. That includes severe allergic r...
  • What conditions does methylprednisolone actually treat?
  • It really depends on what you're being treated for. Some people take a short course for an acute flare and then stop. Others need longer-term treatment for chronic conditions. The...
  • How long will I need to take this medication?
📖 Read our full Methylprednisolone guide →
9
Nutrient depletion considerations

Methylprednisolone may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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

💊 What it looks like

Color White
ShapeOval
Imprint919
Size14 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 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.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.124 $12.40 / 100 tablets
Medicaid paysCMS SDUD · 12 mo $0.3929 $39.29 / 100 tablets
Medicare drug plans payPart D · Q2 2026 $0.3466 $34.66 / 100 tablets
Medicare Part B allowsASP · J7509 $0.160 / J7509 unit
NADAC price history (per ea) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.213 $0.121
▼ Down 42% 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)68382-916-01
11-digit billing NDC68382-0916-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7509
DescriptorMETHYLPREDNISOLONE ORAL, PER 4 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
methylprednisolone 4 mg 00904-6914-61 Major 100 tablets $0.124 AB Availability likely
Methylprednisolone 4 mg 42806-0400-01 Epic 100 tablets $0.124 AB Availability likely
Methylprednisolone 4 mg 62135-0760-01 Chartwell 100 tablets $0.124 Availability likely
Methylprednisolone 4 mg 68084-0149-01 American 100 tablets $0.124 AB Availability likely
methylprednisolone 4 mgthis 68382-0916-01 Zydus 100 tablets $0.124 AB Availability likely
MethylPREDNISolone 4 mg 00603-4593-15 Par 21 tablets $0.126 AB Availability likely +1%
Methylprednisolone 4 mg 59762-4440-02 Mylan 21 tablets $0.126 AB Availability likely +1%
methylprednisolone 4 mg 68001-0624-01 BluePoint 21 tablets $0.126 AB Availability likely +1%
Medrol 4 mg 00009-0056-02 Pharmacia 100 tablets $0.245 AB Availability likely +98%
MethylPREDNISolone 4 mg 55289-0649-30 PD-Rx 30 tablets AB FDA listed
Methylprednisolone 4 mg 57582-0101-01 Tianjin 100 tablets AB FDA listed
MethylPREDNISolone 4 mg 63629-2218-01 Bryant 100 tablets AB FDA listed
Methylprednisolone 4 mg 68071-2370-01 NuCare 21 tablets AB FDA listed
Methylprednisolone 4 mg 68071-5221-01 NuCare 21 tablets AB FDA listed
Methylprednisolone 4 mg 69306-0400-21 Doc 21 tablets AB FDA listed
methylprednisolone 4 mg 70771-1348-01 Zydus 100 tablets AB FDA listed
MethylPREDNISolone 4 mg 72162-1161-01 Bryant 100 tablets AB FDA listed
methylprednisolone 4 mg 82804-0007-21 Proficient 21 tablets AB FDA listed
Methylprednisolone 4 mg 85509-1400-02 PHOENIX 21 tablets AB FDA listed
Methylprednisolone 4 mg 85766-0037-01 Sportpharm 100 tablets AB FDA listed
Methylprednisolone 4 mg 71205-0453-21 Proficient 21 tablets AB FDA listed
Methylprednisolone 4 mg 76420-0041-21 Asclemed 21 tablets AB FDA listed
Methylprednisolone 4 mg 76420-0193-21 Asclemed 21 tablets AB FDA listed
Methylprednisolone 4 mg 63187-0160-21 Proficient 21 tablets AB FDA listed
MethylPREDNISolone 4 mg 63629-2226-01 Bryant 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0230-01 Advanced 21 tablets AB FDA listed
methylprednisolone 4 mg 50090-3811-00 A-S 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0231-01 Advanced 21 tablets AB FDA listed
Methylprednisolone 4 mg 80425-0255-01 Advanced 21 tablets AB FDA listed
Methylprednisolone 4 mg 50090-3094-00 A-S 21 tablets AB FDA listed
Methylprednisolone 4 mg 72189-0264-21 Direct_Rx 21 tablets AB FDA listed
Methylprednisolone 4 mg 68788-7833-02 Preferred 21 tablets AB FDA listed
Methylprednisolone 4 mg 70518-2864-00 REMEDYREPACK 21 tablets AB FDA listed
Methylprednisolone 4 mg 60760-0961-21 St. 21 tablets AB FDA listed
Methylprednisolone 4 mg 70518-4213-00 REMEDYREPACK 21 tablets AB FDA listed
Methylprednisolone 4 mg 85534-0035-00 HAWAII 21 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

🏛️
2018
On the market since
May 2018
📍
2026
Currently FDA-listed
8 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 68382-0916-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
32.4K
Units reimbursed last 4 qtrs
811.9K
Gross reimbursed last 4 qtrs
$319K
Avg / prescription
$9.85
Avg / unit
$0.3929
Latest quarter Q4 2025
9.4KRx
Medicaid pays / ea
$0.3929
gross reimbursed
vs
NADAC / ea
$0.1240
acquisition cost
=
Spread
+$0.2689
+217% 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
20% FFS 80% MCO
Fee-for-service · 6,380 Rx Managed care · 26,008 Rx
State Medicaid map
Alaska: no data reported AK Maine: 6,124 units · 439 per 100k residents ME Washington: 12,910 units · 165 per 100k residents WA Idaho: 4,823 units · 246 per 100k residents ID Montana: 9,839 units · 869 per 100k residents MT North Dakota: no data reported ND Minnesota: 7,763 units · 135 per 100k residents MN Wisconsin: 9,894 units · 167 per 100k residents WI Michigan: 21,985 units · 219 per 100k residents MI New York: 48,945 units · 250 per 100k residents NY Vermont: 3,160 units · 488 per 100k residents VT New Hampshire: 4,486 units · 320 per 100k residents NH Oregon: 9,152 units · 216 per 100k residents OR Nevada: 5,412 units · 169 per 100k residents NV Wyoming: no data reported WY South Dakota: 1,368 units · 149 per 100k residents SD Iowa: 5,776 units · 180 per 100k residents IA Illinois: 22,340 units · 178 per 100k residents IL Indiana: 12,384 units · 180 per 100k residents IN Ohio: 23,216 units · 197 per 100k residents OH Pennsylvania: 37,982 units · 293 per 100k residents PA New Jersey: 47,318 units · 509 per 100k residents NJ Massachusetts: 13,511 units · 193 per 100k residents MA California: 61,878 units · 159 per 100k residents CA Utah: 10,677 units · 312 per 100k residents UT Colorado: 12,541 units · 213 per 100k residents CO Nebraska: 4,576 units · 231 per 100k residents NE Missouri: 14,813 units · 239 per 100k residents MO Kentucky: 20,811 units · 460 per 100k residents KY West Virginia: 6,170 units · 349 per 100k residents WV Virginia: 17,583 units · 202 per 100k residents VA Maryland: 17,866 units · 289 per 100k residents MD Connecticut: 3,668 units · 101 per 100k residents CT Rhode Island: 2,510 units · 229 per 100k residents RI Arizona: 31,394 units · 422 per 100k residents AZ New Mexico: 8,382 units · 396 per 100k residents NM Kansas: 2,838 units · 96.5 per 100k residents KS Arkansas: 5,325 units · 174 per 100k residents AR Tennessee: 15,036 units · 211 per 100k residents TN North Carolina: 24,858 units · 229 per 100k residents NC South Carolina: 4,070 units · 75.7 per 100k residents SC Delaware: 2,990 units · 290 per 100k residents DE Oklahoma: 5,455 units · 135 per 100k residents OK Louisiana: 2,745 units · 60.0 per 100k residents LA Mississippi: 3,084 units · 105 per 100k residents MS Alabama: 6,436 units · 126 per 100k residents AL Georgia: 7,357 units · 66.7 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,112 units · 16.8 per 100k residents TX Florida: 15,875 units · 70.2 per 100k residents FL
Units reimbursed · per 100k residents
16.8869
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 Montana 869 /100k
2 New Jersey 509 /100k
3 Vermont 488 /100k
4 Kentucky 460 /100k
5 Maine 439 /100k
6 Arizona 422 /100k
7 New Mexico 396 /100k
8 West Virginia 349 /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.
21 tablets68382-0916-34 106,506 Rx · $1,103,543
100 tablets this page68382-0916-01 32,388 Rx · $318,971
500 tablets68382-0916-05 No Medicaid data
Drug total (last 4 qtrs): 138,894 Rx · 3,010,001 units · $1,422,514 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 Methylprednisolone — the program that covers self-administered drugs. 9 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 Methylprednisolone. 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
$11.32M
Claims incl. refills
1.6M
Beneficiaries
1.4M
Spend / beneficiary
$7.99
Spend / claim
$7.26
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 Methylprednisolone — the ingredient across all brands.

Top reported reactions

Fatigue10,456
Pain9,982
Nausea9,540
Headache9,504
Pyrexia9,147
Dyspnoea8,789
Arthralgia8,275

Reporter sex

170,235 reports
Male · 42%
Female · 58%
Unknown · 0%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 15,837 5,973
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
68382-0916-01 You're viewing this 100 TABLET in 1 BOTTLE (68382-916-01) $0.1240 / ea $12.40 2018-05-01 Active
68382-0916-05 500 TABLET in 1 BOTTLE (68382-916-05) 2018-05-01 Active
68382-0916-34 1 BLISTER PACK in 1 CARTON (68382-916-34) / 21 TABLET in 1 BLISTER PACK $0.1258 / ea $2.64 2018-05-01 Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1240 NADAC).

This pack accounts for about 23% 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 68382-0916-01?
NDC 68382-0916-01 is a 100-count package — 100 tablet in 1 bottle.
What is the difference between NDC 68382-0916-01 and NDC 68382-0916-34?
Both are methylprednisolone 4 mg Tablet — the drug itself is identical. NDC 68382-0916-01 is the 100-count package, while NDC 68382-0916-34 is the 21 tablets package. Per-ea NADAC also differs: $0.1240 here vs $0.1258 for the 21 tablets pack.
What NDC number is used to bill for this package of methylprednisolone 4 mg Tablet?
Bill NDC 68382-0916-01 — the 11-digit billing format is 68382091601. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

📄 Full prescribing information FDA SPL

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

INDICATIONS AND USAGE Methylprednisolone tablets are indicated in the following conditions: 1.Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer 2.Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis 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 Bullous dermatitis herpetiformis Severe erythema multiforme (Stevens-Johnson syndrome) Severe seborrheic dermatitis Exfoliative dermatitis Mycosis fungoides Pemphigus Severe psoriasis 5.Allergic States Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment: Seasonal or perennial allergic rhinitis Drug hypersensitivity reactions Serum sickness Contact dermatitis Bronchial asthma Atopic dermatitis 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 Keratitis Optic neuritis Allergic conjunctivitis Chorioretinitis Iritis and iridocyclitis 7.Respiratory Diseases Symptomatic sarcoidosis Berylliosis Loeffler's syndrome not manageable by other means 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 methylprednisolone tablets may vary from 4 mg to 48 mg of methylprednisolone 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, methylprednisolone 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 methylprednisolone 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 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 (4 mg of methylprednisolone is equivalent to 5 mg of prednisolone). ADT ® (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 reestablishment of more nearly normal hypothalamic-pituitary-adrenal (HPA) activity on the offsteroid 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 adrenal cortical 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 adrenal cortical 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 adrenal cortical 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…

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 methylprednisolone 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 methylprednisolone withdrawal or dosage reduction as needed. Tuberculosis If methylprednisolone 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 methylprednisolone 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 methylprednisolone.

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 methylprednisolone-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 methylprednisolone-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 methylprednisolone. 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 methylprednisolone.

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 methylprednisolone, may exacerbate systemic fungal infections; therefore, avoid methylprednisolone use in the presence of such infections unless methylprednisolone is needed to control drug reactions. For patients on chronic methylprednisolone therapy who develop systemic fungal infections, methylprednisolone withdrawal or dosage reduction is recommended.

Amebiasis Corticosteroids, including methylprednisolone, may activate latent amebiasis. Therefore, it is recommended that latent amebiasis or active amebiasis be ruled out before initiating methylprednisolone in patients who have spent time in the tropics or patients with unexplained diarrhea. Strongyloides Infestation Corticosteroids, including methylprednisolone, 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 methylprednisolone, in patients with cerebral malaria. Ophthalmic Effects Prolonged use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage…

🤒 Adverse Reactions ~1 min read

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Congestive heart failure in susceptible patients Hypertension Fluid retention Potassium loss Hypokalemic alkalosis Musculoskeletal Muscle weakness Loss of muscle mass Steroid myopathy Osteoporosis Tendon rupture, particularly of the Achilles tendon Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Increases in alanine transaminase (ALT, SGPT), aspartate transaminase (AST, SGOT), and alkaline phosphatase have been observed following corticosteroid treatment.

These changes are usually small, not associated with any clinical syndrome and are reversible upon discontinuation. Dermatologic Impaired wound healing Petechiae and ecchymoses May suppress reactions to skin tests Thin fragile skin Facial erythema Increased sweating Neurological Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Development of Cushingoid state Suppression of growth in children Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Menstrual irregularities Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements of insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Metabolic Negative nitrogen balance due to protein catabolism Vascular Flushing The following additional reactions have been reported following oral as well as parenteral therapy: Urticaria and other allergic, anaphylactic or hypersensitivity reactions.

🔄 Drug Interactions ~1 min read

DRUG INTERACTIONS The pharmacokinetic interactions listed below are potentially clinically important. Mutual inhibition of metabolism occurs with concurrent use of cyclosporin and methylprednisolone; therefore, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporin.

Drugs that induce hepatic enzymes such as phenobarbital, phenytoin and rifampin may increase the clearance of methylprednisolone and may require increases in methylprednisolone dose to achieve the desired response. Drugs such as troleandomycin and ketoconazole may inhibit the metabolism of methylprednisolone and thus decrease its clearance. Therefore, the dose of methylprednisolone should be titrated to avoid steroid toxicity.

Methylprednisolone may increase the clearance of chronic high dose aspirin. This could lead to decreased salicylate serum levels or increase the risk of salicylate toxicity when methylprednisolone is withdrawn. Aspirin should be used cautiously in conjunction with corticosteroids in patients suffering from hypoprothrombinemia.

The effect of methylprednisolone on oral anticoagulants is variable. There are reports of enhanced as well as diminished effects of anticoagulant when given concurrently with corticosteroids. Therefore, coagulation indices should be monitored to maintain the desired anticoagulant effect.

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

📦 How Supplied / Storage and Handling ~1 min read

HOW SUPPLIED Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: NDC 68382-916-01 in bottle of 100 tablets NDC 68382-916-05 in bottle of 500 tablets NDC 68382-916-34 in unit-of-use cartons of 21 tablets Methylprednisolone tablets USP, 8 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '917' on one side and bisect on other side and are supplied as follows: NDC 68382-917-11 in bottle of 25 tablets with child-resistant closure NDC 68382-917-01 in bottle of 100 tablets NDC 68382-917-05 in bottle of 500 tablets NDC 68382-917-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 16 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '918' on one side and quadrisect on other side and are supplied as follows: NDC 68382-918-18 in bottle of 50 tablets with child-resistant closure NDC 68382-918-01 in bottle of 100 tablets NDC 68382-918-05 in bottle of 500 tablets NDC 68382-918-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 32 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '919' on one side and bisect on other side and are supplied as follows: NDC 68382-919-11 in bottle of 25 tablets with child-resistant closure NDC 68382-919-01 in bottle of 100 tablets NDC 68382-919-05 in bottle of 500 tablets NDC 68382-919-77 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20°C to 25° C (68°F to 77° F) [See USP Controlled Room Temperature].

📋 Description 200 words

DESCRIPTION Methylprednisolone tablets contain methylprednisolone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Methylprednisolone, USP occurs as a white to practically white, odorless, crystalline powder.

It melts at about 240°C, with some decomposition. It is practically insoluble in water, sparingly soluble in ethanol (96 %), in dioxane, in methanol and slightly soluble in acetone, in methylene chloride and in chloroform, very slightly soluble in ether. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11, 17, 21-trihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 374.48.

The structural formula is represented below: C 22 H 30 O 5 Each methylprednisolone tablet USP, contains 4 mg, 8 mg, 16 mg or 32 mg of methylprednisolone. In addition each tablet contains the following inactive ingredients: lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinized starch, and sodium starch glycolate. ACTIONS Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Their synthetic analogs are primarily used for their potent anti-inflammatory effects in disorders of many organ systems. Glucocorticoids cause profound and varied metabolic effects. In addition, they modify the body's immune responses to diverse stimuli. methylpredisolone

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