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prednisone 10 mg Tablet, 500-count — NDC 64380-0784-07 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

prednisone 10 mg Tablet, 500-count — NDC 64380-784-07 (Billing 64380-0784-07)

by Strides Pharma Science Limited · 500 TABLET in 1 BOTTLE, PLASTIC

This is a package of 500 tablets of prednisone 10 mg Tablet from Strides Pharma Science Limited, marketed since Sep 2021 and currently FDA-listed; retail pharmacies pay about $0.0533 per tablet (NADAC).

NDC 64380-0784-07
🏷️ FDA NDC (as labeled) 64380-784-07 billing pads the product segment with a zero
This package
Contains500-count Cost per ea$0.0533 NADAC Per package$26.65 / 500 tablets Pack sizes4 compare ↓
Also priced by: Medicaid pays $0.3443/unit · Part D plans $0.2837/unit — full pricing hub ↓
Product page 64380-0784-08 Also comes in: 100 tablets 64380-784-01 100 tablets 64380-784-06 1000 tablets 64380-784-08
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

Past resolved recalls for this product (1)
Class II · Jul 19, 2022 · Terminated — Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets (Strides Pharma Inc.) · FDA recall D-1330-2022

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 64380-784-07
Product NDC 64380-784
11-digit billing NDC 64380078407
NCPDP billing unit EA — each (per item)
RxCUI 198145, 198148, 312615
UNII VB0R961HZT
UPC 0364380949060, 0364380785064, 0364380784067
Application # ANDA208412
SPL Set ID 2ef05381-faad-4e0f-b58d-9f2236a04a2c
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-01
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 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
Quick answers
  • GSN (GCN sequence number): 006749
  • GCN: 27172
  • GPI-14 (Medi-Span): 22100045000320
  • HICL (First Databank): 002879
  • AHFS class code: 68:04.00.00
  • RxCUI (RxNorm): 198145
Why two NDCs? The FDA registers this code as 64380-784-07 — 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 → 64380-0784-07. 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 10 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 $0.053 $26.65 / 500 tablets
Medicaid paysCMS SDUD · 12 mo $0.3443 $172.15 / 500 tablets
Medicare drug plans payPart D · Q2 2026 $0.2837 $141.85 / 500 tablets
Medicare Part B allowsASP · J7512 $0.004 / J7512 unit —
NADAC price history (per ea) — tap or hover for the price & month
Jun 2022 Dec 2023 Mar 2026 Sep 2026 $0.069 $0.053
▼ Down 19% over the last 19 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)64380-784-07
11-digit billing NDC64380-0784-07
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ7512
DescriptorPREDNISONE, IMMEDIATE RELEASE OR DELAYED RELEASE, ORAL, 1 MG
Billing units / pkg10 units
How the units are derivedThis package is 500 EA; the HCPCS unit is 1 MG, so one package = 10 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
64380-0784-01 64380-784-01 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK — — 2021-09-01 — Active
64380-0784-06 64380-784-06 100 TABLET in 1 BOTTLE, PLASTIC $0.0533 / ea $5.33 2021-09-01 — Active
64380-0784-07 You're viewing this 500 TABLET in 1 BOTTLE, PLASTIC $0.0533 / ea $26.64 2021-09-01 — Active
64380-0784-08 64380-784-08 Main listing 1000 TABLET in 1 BOTTLE, PLASTIC $0.0533 / ea $53.28 2021-09-01 — Active

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($0.0533 NADAC).

This pack accounts for about 13% 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 500-count package — 500 tablet in 1 bottle, plastic.
How does this package differ from NDC 64380-0784-01?
Both are prednisone 10 mg Tablet — the drug itself is identical. This page's package is the 500-count one, while NDC 64380-0784-01 is the 100 tablets package.
What NDC number is used to bill for this package of prednisone 10 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 10 mg 00054-9817-25 Hikma 100 tablets $0.053 AB Availability likely —
Prednisone 10 mg 00378-0641-01 Mylan 100 tablets $0.053 — Availability likely —
Prednisone 10 mg 00591-5442-01 Actavis 100 tablets $0.053 — Availability likely —
Prednisone 10 mg 00904-6923-61 Major 100 tablets $0.053 AB Availability likely —
Prednisone 10 mg 59651-0487-01 Aurobindo 100 tablets $0.053 AB Availability likely —
prednisone 10 mg 60219-1707-01 Amneal 100 tablets $0.053 AB Availability likely —
Prednisone 10 mg 60687-0134-01 American 100 tablets $0.053 AB Discontinued —
Prednisone 10 mg 60687-0914-01 American 100 tablets $0.053 AB Availability likely —
PredniSONE Tablets, USP, 10 mg 63561-0121-01 Granulation 100 tablets $0.053 AB Availability likely —
prednisone 10 mgthis 64380-0784-07 Strides 500 tablets $0.053 AB Availability likely —
Prednisone 10 mg 70954-0059-10 ANI 100 tablets $0.053 AB Availability likely —
PredniSONE 10 mg 00054-0017-20 Hikma 100 tablets $0.060 AB FDA listed +14%
Prednisone 10 mg 00603-5338-15 Par 21 tablets $0.585 AB Availability likely +998%
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 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

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color White
ShapeRound
ImprintP50
Size11 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 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

LabelerStrides Pharma Science Limited
Application holderSTRIDES PHARMA GLOBAL PTE LTD
FDA applicationANDA208412 (ANDA)
Labeler code64380
First marketedSep 2021
Product typeHuman Prescription Drug
Portfolio195 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 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~2 min read ▾

INDICATIONS AND USAGE Prednisone tablets USP are indicated in the following conditions: Endocrine Disorders Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice: synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance); congenital adrenal hyperplasia; hypercalcemia associated with cancer; nonsuppurative thyroiditis. Rheumatic Disorders As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis, rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), ankylosing spondylitis, acute and subacute bursitis, acute nonspecific tenosynovitis, acute gouty arthritis, post-traumatic osteoarthritis, synovitis of osteoarthritis, epicondylitis.

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

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

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

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

⏱️ Dosage and Administration ~3 min read ▾

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

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

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

If after long-term therapy the drug is to be stopped, it 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 (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 long-… [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 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 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. Tuberculosis If prednisone tablets 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 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 migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia. Cerebral Malaria Avoid corticosteroids, including prednisone tablets, in patients with cerebral malaria. Kaposi's Sarcoma Kaposi's sarcoma has been reported to occur in patients receiving corticosteroid therapy, most often for ch… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions 183 words ▾

ADVERSE REACTIONS Fluid and Electrolyte Disturbances Sodium retention Fluid retention Congestive heart failure in susceptible patients Potassium loss Hypokalemic alkalosis Hypertension Musculoskeletal Muscle weakness Steroid myopathy Loss of muscle mass Osteoporosis Vertebral compression fractures Aseptic necrosis of femoral and humeral heads Pathologic fracture of long bones Gastrointestinal Peptic ulcer with possible perforation and hemorrhage Pancreatitis Abdominal distention Ulcerative esophagitis Dermatologic Impaired wound healing Thin fragile skin Petechiae and ecchymoses Facial erythema Increased sweating May suppress reactions to skin tests Metabolic Negative nitrogen balance due to protein catabolism Neurological Increased intracranial pressure with papilledema (pseudo-tumor cerebri) usually after treatment Convulsions Vertigo Headache Endocrine Menstrual irregularities Development of Cushingoid state Secondary adrenocortical and pituitary unresponsiveness, particularly in times of stress, as in trauma, surgery or illness Suppression of growth in children Decreased carbohydrate tolerance Manifestations of latent diabetes mellitus Increased requirements for insulin or oral hypoglycemic agents in diabetics Ophthalmic Posterior subcapsular cataracts Increased intraocular pressure Glaucoma Exophthalmos Additional Reactions Urticaria and other allergic, anaphylactic or hypersensitivity reactions To report SUSPECTED ADVERSE REACTIONS, contact Strides Pharma Inc. at 1-877-244-9825 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

🧬 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 ~1 min read ▾

HOW SUPPLIED Prednisone Tablets USP 10 mg - White to off white color, circular, biconvex tablets debossed with 'P10' on one side and break line on other side and free from physical defects. 20 mg - White to off white color, circular, biconvex tablets debossed with 'P20' on one side and break line on other side and free from physical defects. 50 mg - White to off white colour, biconvex round shaped tablet debossed with "P50" on one side, score on other side and free from physical defects.

Product Name NDC Number Pack Type Prednisone Tablets USP, 10 mg 64380-784-06 100's count in HDPE container 64380-784-07 500's count in HDPE container 64380-784-08 1000's count in HDPE container 64380-784-01 10 x 10's Unit-Dose blister pack Prednisone Tablets USP, 20 mg 64380-785-06 100's count in HDPE container 64380-785-07 500's count in HDPE container 64380-785-08 1000's count in HDPE container 64380-785-01 10 x 10's Unit-Dose blister pack Prednisone Tablets USP, 50 mg 64380-949-06 100's Count in HDPE container 64380-949-01 10 x 10's Count blister pack Store at 20° to 25 °C (68° to 77 °F); excursions permitted to 15° to 30 °C (59° to 86 °F) [see USP Controlled Room Temperature].

Dispense in a tight container, as defined in the USP/NF. PROTECT FROM MOISTURE. Rx only Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India.

Distributed by: Strides Pharma Inc. Bridgewater, NJ 08807 Revised: 08/2025

📋 Description 111 words ▾

DESCRIPTION Each tablet for oral administration contains: Prednisone Tablets USP…………………………………… 10 mg, 20 mg and 50 mg Inactive Ingredients The tablets contain lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize starch), sodium starch glycolate and magnesium stearate. Prednisone tablets USP contain prednisone USP, which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract.

The chemical name for prednisone is pregna-1,4-diene-3,11,20-trione monohydrate,17,21-dihydroxy The structural formula is represented below: Prednisone is a white to practically white, odorless, crystalline powder. It is very slightly soluble in water; slightly soluble in alcohol, chloroform, dioxane, and methanol. FDA approved dissolution test specifications differ from USP. structure-prednisone

⚠️ Precautions ~2 min read ▾

PRECAUTIONS General Precautions Drug-induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; 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 and in those with cirrhosis. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of possible corneal perforation. The lowest possible dose of corticosteroid should be used to control the condition under treatment, and when reduction in dosage is possible, the reduction should be gradual.

Psychic derangements may appear when corticosteroids are used, ranging from euphoria, insomnia, mood swings, personality changes, and severe depression, to frank psychotic manifestations. Also existing emotional instability or psychotic tendencies may be aggravated by corticosteroids. Aspirin should be used cautiously in conjunction with corticosteroids in hypoprothrombinemia.

Steroids should be used with caution in nonspecific ulcerative colitis, if there is a probability of impending perforation, abscess or other pyogenic infection: diverticulitis; fresh intestinal anastomoses; active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis: and myasthenia gravis. Growth and development of infants and children on prolonged corticosteroid therapy should be carefully observed. 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 corticosteroids affect the ultimate outcome or natural history of the disease.

The studies do show that relatively high doses of corticosteroids are necessary to demonstrate a significant effect (See DOSAGE AND ADMINISTRATION). 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. Convulsions have been reported with concurrent use of methylprednisolone and cyclosporine.

Since concurrent use of these agents results in a mutual inhibition of metabolism, it is possible that adverse events associated with the individual use of either drug may be more apt to occur. Information for the Patient Patients who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles and, if exposed, to obtain medical advice.

📄 Package Label / Principal Display Panel 15 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL predni-10mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL predni-20mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL predni-50mg

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
34K
Units reimbursed last 4 qtrs
819.5K
Gross reimbursed last 4 qtrs
$282.2K
Avg / prescription
$8.31
Avg / unit
$0.3443
Latest quarter Q1 2026
8.8KRx
Medicaid pays / ea
$0.3443
gross reimbursed
vs
NADAC / ea
$0.0533
acquisition cost
=
Spread
+$0.2910
+546% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
43% FFS 57% MCO
Fee-for-service · 14,550 Rx Managed care · 19,414 Rx
State Medicaid map
Alaska: no data reported AK Maine: 8,079 units · 579 per 100k residents ME Washington: 8,561 units · 110 per 100k residents WA Idaho: 5,825 units · 297 per 100k residents ID Montana: 3,492 units · 308 per 100k residents MT North Dakota: 904 units · 115 per 100k residents ND Minnesota: 9,867 units · 172 per 100k residents MN Wisconsin: 11,695 units · 198 per 100k residents WI Michigan: 43,348 units · 432 per 100k residents MI New York: 185,198 units · 946 per 100k residents NY Vermont: 3,448 units · 533 per 100k residents VT New Hampshire: 299 units · 21.3 per 100k residents NH Oregon: 5,031 units · 119 per 100k residents OR Nevada: 2,497 units · 78.2 per 100k residents NV Wyoming: no data reported WY South Dakota: 3,709 units · 404 per 100k residents SD Iowa: 26,179 units · 816 per 100k residents IA Illinois: 9,163 units · 73.0 per 100k residents IL Indiana: 5,600 units · 81.6 per 100k residents IN Ohio: 31,157 units · 264 per 100k residents OH Pennsylvania: 60,446 units · 466 per 100k residents PA New Jersey: 26,636 units · 287 per 100k residents NJ Massachusetts: 8,956 units · 128 per 100k residents MA California: 51,830 units · 133 per 100k residents CA Utah: 3,022 units · 88.4 per 100k residents UT Colorado: 2,366 units · 40.3 per 100k residents CO Nebraska: 4,978 units · 252 per 100k residents NE Missouri: 16,527 units · 267 per 100k residents MO Kentucky: 29,909 units · 661 per 100k residents KY West Virginia: 14,193 units · 802 per 100k residents WV Virginia: 16,082 units · 185 per 100k residents VA Maryland: 16,819 units · 272 per 100k residents MD Connecticut: 20,715 units · 573 per 100k residents CT Rhode Island: no data reported RI Arizona: 4,181 units · 56.3 per 100k residents AZ New Mexico: 3,196 units · 151 per 100k residents NM Kansas: 308 units · 10.5 per 100k residents KS Arkansas: 3,166 units · 103 per 100k residents AR Tennessee: 13,167 units · 185 per 100k residents TN North Carolina: 22,964 units · 212 per 100k residents NC South Carolina: 1,462 units · 27.2 per 100k residents SC Delaware: 1,965 units · 191 per 100k residents DE Oklahoma: 9,098 units · 224 per 100k residents OK Louisiana: 8,495 units · 186 per 100k residents LA Mississippi: 3,634 units · 124 per 100k residents MS Alabama: 5,842 units · 114 per 100k residents AL Georgia: 6,937 units · 62.9 per 100k residents GA D.C.: no data reported DC Hawaii: 721 units · 50.2 per 100k residents HI Texas: 22,727 units · 74.5 per 100k residents TX Florida: 9,188 units · 40.6 per 100k residents FL
Units reimbursed · per 100k residents
10.5946
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 946 /100k
2 Iowa 816 /100k
3 West Virginia 802 /100k
4 Kentucky 661 /100k
5 Maine 579 /100k
6 Connecticut 573 /100k
7 Vermont 533 /100k
8 Pennsylvania 466 /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 tablets64380-0784-08 223,125 Rx · $1,222,863
500 tablets this page64380-0784-07 33,964 Rx · $282,194
100 tablets64380-0784-06 6,661 Rx · $50,356
100 tablets64380-0784-01 No Medicaid data
Drug total (last 4 qtrs): 263,750 Rx · 6,329,199 units · $1,555,412 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.
← 64380-0783-01 · Strides 64380-0785-01 · Strides →
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.