Quick answers
- What is PredniSONE Intensol?
- PredniSONE Intensol is a brand name of Prednisone, a prescription medicine. The FDA NDC Directory lists 1 PredniSONE Intensol product in 1 strength and form.
- Who makes PredniSONE Intensol?
- Hikma holds the FDA application for PredniSONE Intensol (ANDA088810, approved February 20, 1985).
- Is there a generic or store brand of PredniSONE Intensol?
- Other products of Prednisone are listed with the FDA, but none in exactly the same strength and form as a PredniSONE Intensol product.
- What do pharmacies pay for PredniSONE Intensol?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 PredniSONE Intensol strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has PredniSONE Intensol been recalled?
- FDA enforcement reports list 2 recalls of PredniSONE Intensol products; the newest started October 3, 2016. A recall usually concerns specific lots, not every product.
What PredniSONE Intensol is
Each PredniSONE Intensol product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Prednisone · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| prednisone 5 mg/mL solution, concentrate (oral) | PredniSONE Intensol | None listed | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Prednisone →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA088810 | Hikma | February 20, 1985 | 1 |
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 5 mg/mL solution, concentrate | Generic: PredniSONE Intensol | $3.25 per mL Generic of the same strength and form: $3.25 per mL |
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 PredniSONE Intensol
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of PredniSONE Intensol products.
- Hikma Pharmaceuticals USA Inc.1 product
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.