Quick answers
- What is Prednisolone used for?
- The FDA-approved label (Orapred ODT, Advanz Pharma (US) Corp., June 3, 2025) says: “Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Prednisolone have a boxed warning?
- No. None of the 33 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Prednisolone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Prednisolone been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Prednisolone?
- 23 companies list prescription products of Prednisolone in the FDA NDC Directory, including PAI Holdings, LLC dba PAI Pharma, Edenbridge Pharmaceuticals LLC. and Ingenus Pharmaceuticals, LLC.
What Prednisolone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Orapred ODT (prednisolone sodium phosphate orally disintegrating tablet) is indicated in the treatment of the following diseases or conditions: Orapred ODT is a corticosteroid indicated as an anti-inflammatory or immunosuppressive agent for certain allergic, dermatologic, gastrointestinal, hematologic, ophthalmologic, nervous system, renal, respiratory, rheumatologic, specific infectious diseases or conditions and …
— FDA label: Orapred ODT, Advanz Pharma (US) Corp., effective June 3, 2025. Read the full label on DailyMed →
The FDA has 33 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Conditions named on the label
These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.
Related medical specialties
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 33 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Solution · Tablet, orally disintegrating · Tablet · Solution/ drops · Syrup |
|---|---|
| Route | Oral · Ophthalmic |
| Prescription products | 41 in the FDA NDC Directory |
| Brand names | Orapred ODT |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| prednisolone 15 mg/5 mL solution | Generic | $0.5401–$0.6067 per mL 8 packages, lowest to highest |
| prednisolone 15 mg/5 mL syrup | Generic | $0.5401–$0.6067 per mL 2 packages, lowest to highest |
| prednisolone 5 mg tablet | Generic | $8.30 per tablet |
| prednisolone sodium phosphate 10 mg/5 mL solution | Generic | $2.43 per mL |
| prednisolone sodium phosphate 10 mg/mL solution/ drops | Generic | $4.59 per mL |
| prednisolone sodium phosphate 15 mg/5 mL solution | Generic | $0.1034 per mL |
| prednisolone sodium phosphate 5 mg/5 mL solution | Generic | $0.5491 per mL |
NADAC list of November 4, 2026; these prices took effect between April 22, 2026 and October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- PAI Holdings, LLC dba PAI Pharma6 products
- Edenbridge Pharmaceuticals LLC.4 products
- Ingenus Pharmaceuticals, LLC3 products
- Advanz Pharma (US) Corp.3 products
- Chartwell RX, LLC3 products
- Atlantic Biologicals Corp.2 products
- Chartwell Governmental & Specialty RX, LLC.2 products
- Preferred Pharmaceuticals Inc.2 products
- A-S Medication Solutions2 products
- Bausch & Lomb Incorporated1 product
- BioComp Pharma, Inc.1 product
- Seton Pharmaceuticals LLC1 product
- Proficient Rx LP1 product
- Redpharm Drug1 product
- Remedyrepack Inc.1 product
- Amneal Pharmaceuticals NY LLC1 product
- Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.1 product
- Tulex Pharmaceuticals Inc1 product
- Zhejiang Xianju Pharmaceutical Co., Ltd.1 product
- TruPharma, LLC1 product
- Lannett Company, Inc.1 product
- Hisun Pharmaceuticals USA, Inc.1 product
- Aurobindo Pharma Limited1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA019157 PEDIAPRED | Pai Holdings | May 28, 1986 | 18, latest June 5, 2024 2024: Labeling · 2018: Labeling · 2013: Labeling |
| NDA021959 ORAPRED ODT | Advanz Pharma | June 1, 2006 | 6, latest June 5, 2024 2024: Labeling · 2020: Labeling · 2016: Manufacturing (CMC) |
Generic approvals (15)
- ANDA080531Chartwell Molecular · May 31, 1974
- ANDA040070Bausch and Lomb Inc · July 29, 1994
- ANDA040323Chartwell Rx · May 13, 1999
- ANDA075988Chartwell Rx · May 25, 2004
- ANDA076913Pharm Assoc · April 25, 2005
- ANDA040571Pharm Assoc · August 25, 2005
- ANDA040775Lannett Co Inc · September 21, 2007
- ANDA078465Pharm Assoc · March 7, 2008
- ANDA078988Pharm Assoc · June 9, 2008
- ANDA091396Mission Pharma · September 13, 2010
- ANDA203559Edenbridge Pharms · December 20, 2016
- ANDA216715Amneal · October 25, 2022
- ANDA215673Aurobindo Pharma Ltd · March 17, 2023
- ANDA218083Zhejiang Xianju · May 2, 2024
- ANDA219509Tp Anda Holdings · June 23, 2025
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Orapred ODT, Advanz Pharma (US) Corp., effective June 3, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →