Quick answers
- What is Ketoprofen used for?
- The FDA-approved label (Orudis, Allegis Pharmaceuticals, Inc., January 7, 2026) says: “Carefully consider the potential benefits and risks of ORUDIS capsules USP and other treatment options before deciding to use ORUDIS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). ORUDIS is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ORUDIS is indicated for the management of pain. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ketoprofen have a boxed warning?
- Yes. The FDA label for Orudis has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ketoprofen?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ketoprofen been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ketoprofen?
- 5 companies list prescription products of Ketoprofen in the FDA NDC Directory, including Misemer Pharmaceuticals, Inc., Oncora Pharma, LLC and Allegis Pharmaceuticals, Inc..
What Ketoprofen is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Carefully consider the potential benefits and risks of ORUDIS capsules USP and other treatment options before deciding to use ORUDIS. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). ORUDIS is indicated for the management of the signs and symptoms of rheumatoid arthritis and osteoarthritis. ORUDIS is indicated for the management of pain. …
— FDA label: Orudis, Allegis Pharmaceuticals, Inc., effective January 7, 2026. Read the full label on DailyMed →
The FDA has 5 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.
This label has a boxed warning. Read it on the full label →
5 of 5 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Capsule, extended release |
|---|---|
| Route | Oral |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Orudis |
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 |
|---|---|---|
| ketoprofen 200 mg capsule, extended release | Generic | $6.46 per capsule |
NADAC list of November 4, 2026; these prices took effect on March 18, 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.
- Misemer Pharmaceuticals, Inc.3 products
- Oncora Pharma, LLC1 product
- Allegis Pharmaceuticals, Inc.1 product
- Marnel Pharmaceuticals, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
FDA approval history
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
Generic approvals (2)
- ANDA074014Misemer · January 29, 1993
- ANDA075679Mylan · February 20, 2002
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) — Orudis, Allegis Pharmaceuticals, Inc., effective January 7, 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 →