Quick answers
- What is Prednisone used for?
- The FDA-approved label (Prednisone, Bryant Ranch Prepack, September 8, 2026) says: “PredniSONE 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 …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Prednisone have a boxed warning?
- No. None of the 240 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Prednisone?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Prednisone been recalled?
- FDA enforcement reports list 4 recalls of products of this medicine; the newest started July 19, 2022 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Prednisone?
- 40 companies list prescription products of Prednisone in the FDA NDC Directory, including A-S Medication Solutions, Bryant Ranch Prepack and Proficient Rx LP.
What Prednisone is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
PredniSONE 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 …
— FDA label: Prednisone, Bryant Ranch Prepack, effective September 8, 2026. Read the full label on DailyMed →
The FDA has 240 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 240 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet · Tablet, delayed release · Solution · Solution, concentrate |
|---|---|
| Route | Oral |
| Prescription products | 318 in the FDA NDC Directory |
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 |
|---|---|---|
| prednisone 1 mg tablet | Generic | $0.0397 per tablet |
| prednisone 10 mg tablet | Generic | $0.0521–$0.5711 per tablet 30 packages, lowest to highest |
| prednisone 2.5 mg tablet | Generic | $0.0638 per tablet |
| prednisone 20 mg tablet | Generic | $0.0645 per tablet |
| prednisone 5 mg tablet | Generic | $0.0371–$0.3327 per tablet 29 packages, lowest to highest |
| prednisone 5 mg/5 mL solution | Generic | $0.4322–$0.6040 per mL 2 packages, lowest to highest |
| prednisone 5 mg/mL solution, concentrate | Generic | $3.25 per mL |
| prednisone 50 mg tablet | Generic | $0.1671 per tablet |
NADAC list of November 4, 2026; these prices took effect on 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.
- A-S Medication Solutions43 products
- Bryant Ranch Prepack37 products
- Proficient Rx LP20 products
- NuCare Pharmaceuticals, Inc.18 products
- Northwind Health Company, LLC17 products
- Remedyrepack Inc.15 products
- Hikma Pharmaceuticals USA Inc.14 products
- PD-Rx Pharmaceuticals, Inc.14 products
- Asclemed USA, Inc.11 products
- Advanced Rx of Tennessee, LLC11 products
- Preferred Pharmaceuticals Inc.9 products
- QPharma, Inc.8 products
- Direct_Rx7 products
- Coupler LLC7 products
- Aurobindo Pharma Limited6 products
- American Health Packaging6 products
- ANI Pharmaceuticals, Inc.6 products
- Strides Pharma Science Limited6 products
- Marlex Pharmaceuticals, Inc.5 products
- Par Health USA, LLC5 products
- Cardinal Health 107, LLC5 products
- Amneal Pharmaceuticals NY LLC4 products
- NCS HealthCare of KY, LLC dba Vangard Labs4 products
- St. Mary's Medical Park Pharmacy4 products
- Granulation Technology, Inc.3 products
- Redpharm Drug3 products
- Dr.Reddys Laboratories Inc3 products
- Golden State Medical Supply, Inc.3 products
- Mylan Pharmaceuticals Inc.3 products
- Advanced Rx Pharmacy of Tennessee, LLC3 products
- Actavis Pharma, Inc.3 products
- Chartwell RX, LLC3 products
- Sportpharm LLC3 products
- INA Pharmaceutics Inc2 products
- Aphena Pharma Solutions - Tennessee, LLC2 products
- Atlantic Biologicals Corps1 product
- PharmPak, Inc.1 product
- Medsource Pharmaceuticals1 product
- Unit Dose Solutions, Inc.1 product
- Major Pharmaceuticals1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (34)
- ANDA080356Watson Labs · January 17, 1972
- ANDA080352Hikma · April 21, 1972
- ANDA083677Mylan · February 26, 1974
- ANDA084275Chartwell Molecular · June 27, 1974
- ANDA085161Watson Labs · November 11, 1976
- ANDA085162Watson Labs · November 12, 1976
- ANDA088703Hikma · November 8, 1984
- ANDA088810Hikma · February 20, 1985
- ANDA040362Jubilant Cadista · August 29, 2001
- ANDA040256Ph Health · July 12, 2002
- ANDA040392Ph Health · February 12, 2003
- ANDA040581Ph Health · December 21, 2004
- ANDA040584Ph Health · December 21, 2004
- ANDA040611Jubilant Cadista · June 6, 2005
- ANDA211496Quagen · December 28, 2018
- ANDA211575Novitium Pharma · November 15, 2019
- ANDA213385Amneal · June 16, 2020
- ANDA213386Amneal · June 24, 2020
- ANDA210785Strides Pharma · September 2, 2020
- ANDA208412Strides Pharma · February 11, 2021
- ANDA215246Novitium Pharma · July 6, 2021
- ANDA215671Aurobindo Pharma Ltd · November 16, 2021
- ANDA215672Aurobindo Pharma Ltd · March 28, 2022
- ANDA212629Pharmazone · December 5, 2023
- ANDA219477DR Reddys · October 1, 2025
- ANDA218035DR Reddys · June 26, 2026
- ANDA080292—
- ANDA084122—
- ANDA084283—
- ANDA087342—
- ANDA087801—
- ANDA088832—
- ANDA209727—
- ANDA211495—
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
July 19, 2022 · Class II · Terminated · D-1330-2022
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06. — Strides Pharma Inc.
-
March 4, 2020 · Class III · Terminated · D-1035-2020
Labeling: Incorrect or Missing Exp Date - An incorrect expiration date has been identified on Prednisone Tablets USP 5 mg
PrediniSONE Tablets, USP 5 mg, 48-count bottle, Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977, NDC 0603-5337-31 — Par Pharmaceutical Inc.
-
October 3, 2016 · Class II · Terminated · D-0008-2017
Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.
PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25. — West-Ward Pharmaceutical
-
June 14, 2013 · Class III · Terminated · D-882-2013
Labeling: Missing Label; missing label on blister card
Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablets per blister card, ten blister cards per carton, Roxanne, Columbus, OH --- NDC 0054-0018-20 — Boehringer Ingelheim Roxane Inc
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Prednisone, Bryant Ranch Prepack, effective September 8, 2026; 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 →